Cyclophosphamide ( DrugBank: Cyclophosphamide )


44 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症2
13多発性硬化症/視神経脊髄炎21
14慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー1
16クロウ・深瀬症候群2
19ライソゾーム病4
20副腎白質ジストロフィー2
26HTLV-1関連脊髄症3
28全身性アミロイドーシス35
35天疱瘡4
36表皮水疱症3
40高安動脈炎3
41巨細胞性動脈炎1
42結節性多発動脈炎9
43顕微鏡的多発血管炎28
44多発血管炎性肉芽腫症25
45好酸球性多発血管炎性肉芽腫症6
46悪性関節リウマチ2
49全身性エリテマトーデス25
50皮膚筋炎/多発性筋炎5
51全身性強皮症23
52混合性結合組織病2
56ベーチェット病2
60再生不良性貧血61
62発作性夜間ヘモグロビン尿症3
65原発性免疫不全症候群18
66IgA腎症5
84サルコイドーシス1
85特発性間質性肺炎1
93原発性胆汁性胆管炎1
96クローン病9
162類天疱瘡(後天性表皮水疱症を含む。)1
164眼皮膚白皮症3
172低ホスファターゼ症1
205脆弱X症候群関連疾患1
222一次性ネフローゼ症候群24
224紫斑病性腎炎3
256筋型糖原病1
274骨形成不全症1
283後天性赤芽球癆3
284ダイアモンド・ブラックファン貧血3
285ファンコニ貧血18
288自己免疫性後天性凝固因子欠乏症2
326大理石骨病3
331特発性多中心性キャッスルマン病5

11. 重症筋無力症


臨床試験数 : 332 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04561557
(ClinicalTrials.gov)
September 22, 202010/9/2020Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous SystemAn Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous SystemAutoimmune Diseases;Autoimmune Diseases of the Nervous System;Neuromyelitis Optica Spectrum Disorder;Myasthenia Gravis;Chronic Inflammatory Demyelinating Polyradiculoneuropathy;Immune-Mediated Necrotizing MyopathyBiological: CT103A cells;Drug: Cyclophosphamide and fludarabineTongji HospitalNanjing IASO Biotherapeutics Co.,LtdRecruiting18 Years75 YearsAll18Early Phase 1China
2NCT00424489
(ClinicalTrials.gov)
February 200218/1/2007Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia GravisHematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia GravisMyasthenia GravisBiological: Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Drug: ATG (rabbit);Drug: Mesna;Drug: Methylprednisolone;Drug: G-CSFNorthwestern UniversityNULLTerminated15 Years65 YearsAll9Phase 1United States

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05482542
(ClinicalTrials.gov)
January 1, 202312/7/2022Optimal Conditioning Regimen for Autologous Transplantation of Relapsing Remitting Multiple SclerosisOptimal Conditioning Regimen Protocol for Autologous Hematopoietic Stem Cell Transplantation of Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingOther: Autologous hematopoietic stem cell transplantation;Drug: Cyclophosphamide/ATG;Drug: Cyclophosphamide/RituximabScripps HealthNULLRecruiting18 Years58 YearsAll200N/AUnited States
2NCT04561557
(ClinicalTrials.gov)
September 22, 202010/9/2020Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous SystemAn Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous SystemAutoimmune Diseases;Autoimmune Diseases of the Nervous System;Neuromyelitis Optica Spectrum Disorder;Myasthenia Gravis;Chronic Inflammatory Demyelinating Polyradiculoneuropathy;Immune-Mediated Necrotizing MyopathyBiological: CT103A cells;Drug: Cyclophosphamide and fludarabineTongji HospitalNanjing IASO Biotherapeutics Co.,LtdRecruiting18 Years75 YearsAll18Early Phase 1China
3EUCTR2019-001549-42-GB
(EUCTR)
27/03/202003/02/2020Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MSA multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS Highly active relapsing remitting multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide monohydrate
INN or Proposed INN: Cyclophosphamide monohydrate
Product Name: Filgrastim
INN or Proposed INN: Filgrastim
Trade Name: Thymoglobuline
Product Name: Thymoglobuline
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
Trade Name: Alemtuzumab
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Product Name: Lenograstim
INN or Proposed INN: Lenograstim
Trade Name: Ocrelizumab
Product Name: Ocrelizumab
Sheffield Teaching HospitalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
198Phase 3United Kingdom
4NCT03829566
(ClinicalTrials.gov)
November 20191/2/2019Autologous Transplant To End NMO Spectrum DisorderAutologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica;Devic's Disease;NMO Spectrum DisorderDrug: Rituximab;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLWithdrawn18 Years65 YearsAll0Phase 2/Phase 3United States
5EUCTR2017-001362-25-NL
(EUCTR)
30/09/201910/09/2019 Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS Relapsing remitting multiple sclerosis.
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Trade Name: Thymoglobuline®
Product Name: Thymoglobuline®
INN or Proposed INN: ANTITHYMOCYTE IMMUNOGLOBULIN
Other descriptive name: ANTITHYMOCYTE IMMUNOGLOBULIN
Trade Name: Lemtrada
INN or Proposed INN: ALEMTUZUMAB
Other descriptive name: ALEMTUZUMAB
Trade Name: Mavenclad
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Trade Name: Ocrevus
Product Name: Ocrelizumab
INN or Proposed INN: ocrelizumab
Other descriptive name: OCRELIZUMAB
Helse Bergen HF, Haukeland University HospitalNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noDenmark;Netherlands
6EUCTR2017-001362-25-DK
(EUCTR)
27/06/201821/03/2018Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS Relapsing remitting multiple sclerosis.
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sendoxane
Product Name: Cyclophosphamide
Trade Name: Thymoglobuline®
Product Name: Thymoglobuline®
Trade Name: Lemtrada
Product Name: alemtuzumab
Trade Name: Sendoxane
Product Name: Cyclophosphamide
Trade Name: Mavenclad
Product Name: Cladribine
Trade Name: Ocrevus
Product Name: Ocrelizumab
Helse Bergen HF, Haukeland University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3Denmark;Netherlands
7EUCTR2017-001362-25-SE
(EUCTR)
02/05/201817/10/2017Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS Relapsing remitting multiple sclerosis.
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Sendoxane
Product Name: Cyclophosphamide
Trade Name: Thymoglobuline®
Product Name: Thymoglobuline®
Trade Name: Lemtrada
Trade Name: Mavenclad
Product Name: Cladribine
Trade Name: Ocrevus
Product Name: ocrelizumab
Helse Bergen HF, Haukeland University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3Denmark;Netherlands;Sweden
8NCT03477500
(ClinicalTrials.gov)
March 21, 201813/2/2018RCT Comparing Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab in MSRandomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for Patients With Relapsing Remitting Multiple SclerosisMultiple SclerosisDrug: Cyclophosphamide and ATG;Drug: Alemtuzumab;Drug: Cladribine Pill;Drug: OcrelizumabHaukeland University HospitalNULLRecruiting18 Years50 YearsAll100Phase 3Denmark;Netherlands;Norway;Sweden
9NCT03342638
(ClinicalTrials.gov)
November 8, 20179/11/2017Maximizing Outcome of Multiple Sclerosis TransplantationMaximizing Outcome of Multiple Sclerosis Transplantation: MOST TrialMultiple Sclerosis, Relapsing-RemittingDrug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLTerminated18 Years58 YearsAll66Phase 3United States
10NCT02529839
(ClinicalTrials.gov)
October 201510/6/2015Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation (BMT) in Patients With Multiple Sclerosis (MS)Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation in Patients With Multiple SclerosisMultiple SclerosisProcedure: Autologous bone marrow transplantation;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: AlemtuzumabHadassah Medical OrganizationNULLNot yet recruiting18 Years65 YearsBoth20N/ANULL
11NCT01679041
(ClinicalTrials.gov)
November 201229/8/2012High Dose Chemo With Stem Cell Transplant as Treatment for Multiple Sclerosis That Failed Prior TreatmentA Phase II Study of High Dose Chemotherapy With Autologous Hematopoietic Progenitor Cell Transplant for Multiple Sclerosis That Failed at Least Two Lines of TherapyMultiple SclerosisDrug: Alemtuzumab;Drug: Fludarabine;Drug: CyclophosphamideSeah Lim M.D.NULLTerminated18 Years60 YearsBoth1Phase 2United States
12EUCTR2010-023560-40-SE
(EUCTR)
23/03/201121/12/2010Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST Relapsing-remitting multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Sendoxan
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Trade Name: Thymoglobuline
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN
Trade Name: Neupogen
Trade Name: Solu-Medrol
Uppsala l?ns landstingNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120United States;Canada;Brazil;Sweden
13NCT00939549
(ClinicalTrials.gov)
November 201014/7/2009High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple SclerosisPhase II Study of High Dose Cyclophosphamide Followed by Glatiramer Acetate in the Treatment of Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: Cyclophosphamide/Glatiramer acetateJohns Hopkins UniversityNULLWithdrawn18 Years70 YearsAll0Phase 2United States
14EUCTR2007-000586-38-IT
(EUCTR)
21/12/200710/01/2008HIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - NDHIGH-DOSE IMMUNOSUPPRESSION WITH THIOTEPA AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN MULTIPLE SCLEROSIS - ND PATIENTS AFFECTED BY MULTIPLE SCLEROSIS
MedDRA version: 6.1;Level: HLT;Classification code 10052785
Trade Name: THIOPLEX
INN or Proposed INN: Thiotepa
Trade Name: ENDOXAN BAXTER
INN or Proposed INN: Cyclophosphamide
Trade Name: NEUPOGEN
INN or Proposed INN: Filgrastim
OSPEDALE S. RAFFAELENULLNot RecruitingFemale: yes
Male: yes
30Phase 2Italy
15EUCTR2006-002562-19-IT
(EUCTR)
21/04/200624/01/2007Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHTImmunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHT VERIFICARE Patients with multiple sclerosis, age between 18 and 50
MedDRA version: 6.1;Level: PT;Classification code 10028245
Trade Name: L04AA04 - IMMUNOGLOBULINA ANTITIMOCITARIA (DI CONIGLIO) IMMUNOGLOBULINA DI CONIGLIO ANTITIMOCITI UMANI THYMOGLOBULINE
Product Name: Thymoglobuline
INN or Proposed INN: Antithymocyte
Trade Name: Endoxan - ciclofosfamide
Product Name: Endoxan
INN or Proposed INN: Cyclophosfamide
Dipartimento di Neuroscienze Oftalmologia e Genetica DINOG - Universita di GenovaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Italy
16NCT00241254
(ClinicalTrials.gov)
December 200517/10/2005Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Secondary Progressive Multiple SclerosisA Double-blind, Two-arm, Multicenter, Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis: P.R.OM.E.S.S StudyMultiple Sclerosis, Chronic ProgressiveDrug: Cyclophosphamide (drug);Drug: Methylprednisolone (drug)University Hospital, BordeauxMinistry of Health, FranceCompleted18 Years65 YearsBoth138Phase 3France
17NCT00296205
(ClinicalTrials.gov)
October 200323/2/2006Phase II High-Dose Cyclophosphamide for Multiple SclerosisPhase II Trial of High-dose Cyclophosphamide for Moderate to Severe Refractory Multiple SclerosisMultiple SclerosisDrug: CyclophosphamideStony Brook UniversityNULLWithdrawn18 Years75 YearsBoth25Phase 2United States
18NCT00017628
(ClinicalTrials.gov)
April 20016/6/2001Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple SclerosisMultiple SclerosisDrug: cyclophosphamide;Drug: filgrastim;Drug: methylprednisolone;Procedure: Autologous Stem Cell TransplantationNorthwestern Memorial HospitalNULLCompletedN/A59 YearsBoth20Phase 1United States
19NCT00040482
(ClinicalTrials.gov)
April 199926/6/2002High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple SclerosisIntensive Immunosuppression Followed by Rescue With CD34 Selected, T Cell Depleted, Leukopheresis Products in Patients With Multiple SclerosisMultiple SclerosisDrug: Cyclophosphamide;Drug: ATG;Drug: MESNA;Procedure: Radiation therapyBaylor College of MedicineThe Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of MedicineCompleted18 Years60 YearsAll10Phase 2United States
20NCT00014755
(ClinicalTrials.gov)
December 199710/4/2001Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple SclerosisMultiple SclerosisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: filgrastim;Drug: prednisone;Procedure: peripheral blood stem cell transplantation;Procedure: irradiationFred Hutchinson Cancer Research CenterNULLCompleted18 Years60 YearsBoth35Phase 1United States
21EUCTR2008-005773-35-IT
(EUCTR)
15/01/2013AUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SMAUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SM MULTIPLE SCLEROSIS
MedDRA version: 15.1;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: ENDOXAN BAXTER
INN or Proposed INN: Cyclophosphamide
Trade Name: FLUDARA
INN or Proposed INN: Fludarabine
Trade Name: THYMOGLOBULINE
INN or Proposed INN: Antithymocyte immunoglobulin (rabbit)
Trade Name: MABTHERA
INN or Proposed INN: Rituximab
AZIENDA OSPEDALIERA DI PADOVANULLNAFemale: yes
Male: yes
Phase 1Italy

14. 慢性炎症性脱髄性多発神経炎/多巣性運動ニューロパチー


臨床試験数 : 175 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01236456
(ClinicalTrials.gov)
October 20035/11/2010High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating PolyneuropathyA Phase II Trial of High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating PolyneuropathyChronic Inflammatory Demyelinating PolyneuropathyDrug: CyclophosphamideStony Brook UniversityNULLWithdrawn18 Years75 YearsAll0Phase 2United States

16. クロウ・深瀬症候群


臨床試験数 : 13 薬物数 : 14 - (DrugBank : 7) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 75
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs031180421
15/08/201625/03/2019LDCY-POEMS studyPhase II study of efficiency of peripheral blood stem cell harvest using low-dose cyclophosphamide plus G-CSF for POEMS syndrome POEMS syndrome
POEMS syndrome
Treatment by cyclophosphamide, mesna, graniserton, and lenograstim. Autologous peripheral blood stem cell harvest (auto-PBSCH)Sakaida EmikoNULLRecruiting>= 20age old<= 70age oldBoth14Phase 2Japan
2JPRN-UMIN000018385
2015/07/0122/07/2015Phase II study of efficiency of peripheral blood stem cell harvest in POEMS syndrome patients with low-dose cyclophosphamide plus G-CSFPhase II study of efficiency of peripheral blood stem cell harvest in POEMS syndrome patients with low-dose cyclophosphamide plus G-CSF - Phase II study of efficiency of peripheral blood stem cell harvest in POEMS syndrome patients with low-dose cyclophosphamide plus G-CSF POEMS syndromeThis study is composed of the following two steps of therapy.
1)PBSC mobilization using low dose cyclophosphamide and G-CSF
2)autologous peripheral stem cell transplantation after high dose chemotherapy
Chiba University HospitalDepartment of HematologyNULLPending20years-old70years-oldMale and Female14Phase 2Japan

19. ライソゾーム病


臨床試験数 : 899 薬物数 : 684 - (DrugBank : 99) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 182
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01043640
(ClinicalTrials.gov)
December 20095/1/2010Allogeneic Bone Marrow Transplant for Inherited Metabolic DisordersAllogeneic Hematopoietic Stem Cell Transplantation for Standard Risk Inherited Metabolic DisordersMucopolysaccharidosis;Hurler Syndrome;Hunter Syndrome;Maroteaux-Lamy Syndrome;Sly Syndrome;Alpha Mannosidosis;Fucosidosis;Aspartylglucosaminuria;Adrenoleukodystrophy (ALD);Krabbe Disease;Metachromatic Leukodystrophy (MLD);Sphingolipidoses;Peroxisomal DisordersDrug: Campath-1H;Drug: Cyclophosphamide;Drug: Busulfan;Procedure: Allogeneic stem cell transplantation;Drug: Cyclosporine A;Drug: Mycophenolate MofetilMasonic Cancer Center, University of MinnesotaNULLCompletedN/A21 YearsAll46Phase 2United States
2NCT00668564
(ClinicalTrials.gov)
March 200825/4/2008Hematopoietic Stem Cell Transplantation (HCT) for Inborn Errors of MetabolismTreatment of Lysosomal and Peroxisomal Inborn Errors of Metabolism by Hematopoietic Cell TransplantationHurler's Syndrome;Maroteaux-Lamy Syndrome;Sly Syndrome;Alpha Mannosidosis;Fucosidosis;Aspartylglucosaminuria;Sphingolipidoses;Krabbe Disease;Wolman's Disease;Niemann-Pick Disease Type B;Niemann-Pick Disease, Type CProcedure: Stem Cell Transplantation;Drug: Cyclophosphamide;Drug: Campath-1H;Drug: BusulfanMasonic Cancer Center, University of MinnesotaNULLTerminatedN/A21 YearsAll18Phase 2United States
3NCT00176917
(ClinicalTrials.gov)
May 199912/9/2005Stem Cell Transplantation for HurlerHematopoietic Stem Cell Transplantation for Hurler Syndrome, Maroteaux Lamy Syndrome (MPS VI), and Alpha Mannosidase Deficiency (Mannosidosis)Mucopolysaccharidosis I;Mucopolysaccharidosis VI;Mannosidosis;Mucolipidosis Type II (I-cell Disease)Procedure: Stem Cell Transplant;Drug: Busulfan, Cyclophosphamide, ATGMasonic Cancer Center, University of MinnesotaNULLCompletedN/AN/AAll41Phase 2United States
4NCT00176904
(ClinicalTrials.gov)
January 199512/9/2005Stem Cell Transplant for Inborn Errors of MetabolismTreatment of Lysosomal and Peroxisomal Inborn Errors of Metabolism by Bone Marrow TransplantationAdrenoleukodystrophy;Metachromatic Leukodystrophy;Globoid Cell Leukodystrophy;Gaucher's Disease;Fucosidosis;Wolman Disease;Niemann-Pick Disease;Batten Disease;GM1 Gangliosidosis;Tay Sachs Disease;Sandhoff DiseaseProcedure: Stem Cell Transplant;Drug: Busulfan, Cyclophosphamide, Antithymocyte GlobulinMasonic Cancer Center, University of MinnesotaNULLCompletedN/AN/AAll135Phase 2/Phase 3United States

20. 副腎白質ジストロフィー


臨床試験数 : 61 薬物数 : 90 - (DrugBank : 31) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 126
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01043640
(ClinicalTrials.gov)
December 20095/1/2010Allogeneic Bone Marrow Transplant for Inherited Metabolic DisordersAllogeneic Hematopoietic Stem Cell Transplantation for Standard Risk Inherited Metabolic DisordersMucopolysaccharidosis;Hurler Syndrome;Hunter Syndrome;Maroteaux-Lamy Syndrome;Sly Syndrome;Alpha Mannosidosis;Fucosidosis;Aspartylglucosaminuria;Adrenoleukodystrophy (ALD);Krabbe Disease;Metachromatic Leukodystrophy (MLD);Sphingolipidoses;Peroxisomal DisordersDrug: Campath-1H;Drug: Cyclophosphamide;Drug: Busulfan;Procedure: Allogeneic stem cell transplantation;Drug: Cyclosporine A;Drug: Mycophenolate MofetilMasonic Cancer Center, University of MinnesotaNULLCompletedN/A21 YearsAll46Phase 2United States
2NCT00176904
(ClinicalTrials.gov)
January 199512/9/2005Stem Cell Transplant for Inborn Errors of MetabolismTreatment of Lysosomal and Peroxisomal Inborn Errors of Metabolism by Bone Marrow TransplantationAdrenoleukodystrophy;Metachromatic Leukodystrophy;Globoid Cell Leukodystrophy;Gaucher's Disease;Fucosidosis;Wolman Disease;Niemann-Pick Disease;Batten Disease;GM1 Gangliosidosis;Tay Sachs Disease;Sandhoff DiseaseProcedure: Stem Cell Transplant;Drug: Busulfan, Cyclophosphamide, Antithymocyte GlobulinMasonic Cancer Center, University of MinnesotaNULLCompletedN/AN/AAll135Phase 2/Phase 3United States

26. HTLV-1関連脊髄症


臨床試験数 : 29 薬物数 : 47 - (DrugBank : 29) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 119
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04301076
(ClinicalTrials.gov)
June 15, 20206/3/2020Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment (EPOCH) for Adult T-Cell Leukemia-Lymphoma (ATL)A Phase 1 Study of Lenalidomide in Combination With EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL)Acute Adult T-Cell Leukemia/Lymphoma;Adult T-Cell Leukemia/Lymphoma;Chronic Adult T-Cell Leukemia/Lymphoma;HTLV-1 InfectionDrug: Cyclophosphamide;Drug: Doxorubicin Hydrochloride;Drug: Etoposide;Drug: Lenalidomide;Drug: Prednisone;Drug: Vincristine SulfateNational Cancer Institute (NCI)NULLRecruiting18 YearsN/AAll30Phase 1United States
2NCT01000285
(ClinicalTrials.gov)
September 201019/10/2009EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia LymphomaPhase I/II Trial of Dose-Adjusted EPOCH Chemotherapy With Bortezomib Combined With Integrase Inhibitor Therapy for HTLV-1 Associated T-Cell Leukemia LymphomaLeukemia-Lymphoma, Adult T-CellDrug: Bortezomib;Drug: Etoposide;Drug: Vincristine;Drug: Doxorubicin;Drug: Prednisone;Drug: Cyclophosphamide;Drug: RaltegravirWashington University School of MedicineNULLCompleted18 YearsN/AAll18Phase 1/Phase 2United States
3NCT00041327
(ClinicalTrials.gov)
October 20028/7/2002Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/LymphomaPhase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's LymphomaLymphomaBiological: filgrastim;Biological: recombinant interferon alfa;Drug: Etoposide;Drug: cyclophosphamide;Drug: doxorubicin hydrochloride;Drug: lamivudine;Drug: prednisone;Drug: vincristine sulfate;Drug: zidovudineAIDS Malignancy ConsortiumNational Cancer Institute (NCI)Completed18 Years120 YearsBoth19Phase 2United States

28. 全身性アミロイドーシス


臨床試験数 : 267 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2031220037
20/06/202223/04/2022A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL AmyloidosisA Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis - AFFIRM-AL Light Chain (AL) Amyloidosis- Birtamimab group:
Intravenous administration of 24 mg/kg birtamimab every 28 days. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care is co-administered as Standard of Care Chemotherapy
- Placebo group:
Intravenous 0.9% Saline administration as a placebo every 28 days. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care is co-administered as Standard of Care Chemotherapy
Nie ChristieNULLRecruiting>= 18age oldNot applicableBoth16Phase 3Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Republic of Korea;Netherlands;New Zealand;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;United States;Japan
2NCT04754945
(ClinicalTrials.gov)
April 28, 20219/2/2021Isatuximab as Upfront Therapy for the Treatment of High Risk AL AmyloidosisSlow-Go Strategy for High Risk AL Amyloidosis: Isatuximab for Upfront TherapyAL AmyloidosisDrug: Bortezomib;Drug: Cyclophosphamide;Drug: Dexamethasone;Biological: IsatuximabEmory UniversitySanofi;National Cancer Institute (NCI)Recruiting18 YearsN/AAll25Phase 1United States
3NCT04504825
(ClinicalTrials.gov)
February 2, 202120/7/2020A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL AmyloidosisA Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL AmyloidosisAL AmyloidosisDrug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimenAlexionNULLRecruiting18 YearsN/AAll124Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Switzerland;United Kingdom
4NCT04512235
(ClinicalTrials.gov)
November 12, 202010/8/2020A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL AmyloidosisA Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL AmyloidosisAL AmyloidosisDrug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimenAlexionNULLRecruiting18 YearsN/AAll267Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom
5NCT04304144
(ClinicalTrials.gov)
March 18, 202028/2/2020A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL AmyloidosisCAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL AmyloidosisAL AmyloidosisDrug: CAEL-101;Drug: SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD);Drug: DaratumumabAlexion PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll25Phase 2United States
6NCT04612582
(ClinicalTrials.gov)
January 1, 202015/6/2020Comparison of BTD and BCD Based Regimens in the Treatment of AL AmyloidosisA Comparative Study of Bortezomib-Thalidomide-Dexamethason and Bortezomib-Cyclophosphamide-Dexamethason in the Treatment of Monoclonal Immunoglobulin Light Chain Amyloidosis: A Prospective Randomized Controlled Trial(BTD-CHINA-TRIAL)Immunoglobulin Light-Chain AmyloidosisDrug: Thalidomide;Drug: CyclophosphamideGuangdong Provincial People's HospitalNULLRecruiting18 Years80 YearsAll70Phase 4China
7EUCTR2016-001737-27-GB
(EUCTR)
08/10/201811/01/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
8EUCTR2016-001737-27-PL
(EUCTR)
06/09/201816/07/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Romania;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of;Sweden
9EUCTR2016-001737-27-DK
(EUCTR)
22/08/201804/06/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Australia;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
10JPRN-JapicCTI-183929
17/7/201813/04/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AmyloidosisIntervention name : Cyclophosphamide, Bortezomib, dexamethasone plus Daratumumab
INN of the intervention : -
Dosage And administration of the intervention : Participants will receive dexamethasone (20mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing) followed by 1800 mg of daratumumab subcutaneously followed by cyclophosphamide (300 mg/m^2 orally or IV dose weekly) and bortezomib (1.3 mg/m^2 subcutaneous injection weekly) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 2 years.
Control intervention name : Cyclophosphamide, Bortezomib, dexamethasone
INN of the control intervention : -
Dosage And administration of the control intervention : Participants will receive dexamethasone (40milligrams [mg] orally or intravenous [IV]dose), followed by cyclophosphamide (300milligram per meter square [mg/m^2] orally or IV dose), then bortezomib (1.3 mg/m^2 subcutaneous injection) weekly on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles.
Janssen Pharmaceutical K.K.NULLcomplete20BOTH370Phase 4Japan, Asia except Japan, North America, Europe
11EUCTR2016-001737-27-SE
(EUCTR)
07/05/201820/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
12EUCTR2016-001737-27-DE
(EUCTR)
16/04/201816/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
13EUCTR2016-001737-27-GR
(EUCTR)
16/04/201822/03/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
14EUCTR2016-001737-27-NL
(EUCTR)
15/03/201829/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Germany;Netherlands;Japan;China;Korea, Republic of;Sweden
15EUCTR2016-001737-27-IT
(EUCTR)
01/03/201817/06/2021A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis - ANDROMEDA AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis)
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: daratumumab coformulato con ialuronidasi umana ricombinante (rHuPH20)
Product Code: [JnJ 54767414]
INN or Proposed INN: Daratumumab
Other descriptive name: HUMAX-CD38
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of
16EUCTR2016-001737-27-ES
(EUCTR)
06/02/201823/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
17EUCTR2016-001737-27-HU
(EUCTR)
25/01/201828/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
18EUCTR2016-001737-27-BE
(EUCTR)
16/01/201816/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of;Sweden
19NCT03201965
(ClinicalTrials.gov)
October 5, 201727/6/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL AmyloidosisAmyloidosisDrug: Cyclophosphamide;Drug: Bortezomib;Drug: Dexamethasone, 40 mg;Drug: DaratumumabJanssen Research & Development, LLCNULLActive, not recruiting18 YearsN/AAll416Phase 3Canada;China;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Spain;Sweden;Turkey;United Kingdom;United States;Romania;Australia;Belgium;Brazil
20ChiCTR-IPR-17012637
2017-10-012017-09-11Prospective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosisProspective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosis type AL amyloidosisGroup 1:the combination regimen of bortezomib +thalidomide + dexamethasone (VTD);Group 2:the combination regimen of bortezomib + cyclophosphamide + dexamethasone (VCD);Guangdong General HospitalNULLPending1875BothGroup 1:35;Group 2:35;China
21NCT03252600
(ClinicalTrials.gov)
August 25, 201724/7/2017Lenalidomide, Dexamethasone, and Elotuzumab With or Without Cyclophosphamide in Treating Patients With Relapsed Primary AmyloidosisA Randomized Phase 2 Trial of Lenalidomide/ Dexamethasone/ Elotuzumab +/- Cyclophosphamide Followed by Lenalidomide/ Dexamethasone/Elotuzumab Maintenance as Second-Line Therapy for Patients With Relapsed AL AmyloidosisRecurrent Primary AmyloidosisDrug: Cyclophosphamide;Drug: Dexamethasone;Biological: Elotuzumab;Other: Laboratory Biomarker Analysis;Drug: Lenalidomide;Other: Pharmacological StudyBarbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI);Bristol-Myers Squibb;Multiple Myeloma Research ConsortiumActive, not recruiting18 YearsN/AAll53Phase 2United States
22NCT03236792
(ClinicalTrials.gov)
June 12, 201720/7/2017Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL AmyloidosisPhase 1/2 Study Of Ixazomib In Combination With Cyclophosphamide And Dexamethasone In Patients With Newly Diagnosed Immunoglobulin Light Chain AL AmyloidosisAL AmyloidosisDrug: Ixazomib;Drug: Cyclophosphamide;Drug: DexamethasoneIcahn School of Medicine at Mount SinaiMillennium Pharmaceuticals, Inc.Completed18 YearsN/AAll28Phase 1/Phase 2United States
23ChiCTR-IPR-16008422
2016-05-052016-05-08Randomized controlled study of the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD) and bortezomib +thalidomide + dexamethasone (BTD) for the initial treatment of primary systemic amyloidosis (AL)Randomized controlled study of the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD) and bortezomib +thalidomide + dexamethasone (BTD) for the initial treatment of primary systemic amyloidosis (AL) primary systemic amyloidosis (AL)the first group: the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD);the second group:the combination regimen of bortezomib +thalidomide + dexamethasone (BTD) ;People's Hospital, Beijing UniversityNULLRecruiting1875Boththe first group:60;the second group:60;China
24NCT01849783
(ClinicalTrials.gov)
April 4, 20136/5/2013Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple MyelomaSingle Autologous Transplant Followed by Consolidation and Maintenance for Participants = 65 Years of Age Diagnosed With Multiple Myeloma or a Related Plasma Cell MalignancyExtramedullary Plasmacytoma;Isolated Plasmacytoma of Bone;Light Chain Deposition Disease;Primary Systemic Amyloidosis;Stage I Multiple Myeloma;Stage II Multiple Myeloma;Stage III Multiple MyelomaDrug: dexamethasone;Drug: cisplatin;Drug: doxorubicin;Drug: cyclophosphamide;Drug: etoposide;Drug: bortezomib;Drug: thalidomide;Drug: melphalan;Procedure: autologous stem cell transplantYogesh JethavaNational Cancer Institute (NCI)Active, not recruiting65 Years85 YearsAll41Phase 2United States
25NCT01194791
(ClinicalTrials.gov)
October 201026/7/2010Lendexal in Patients With Primary Systemic Amyloidosis (AL) Newly DiagnosedA Multicentric, Phase II Trial of Lenalidomide, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed, Not Candidates for Hematopoietic Stem Cell TransplantationPrimary Systemic AmyloidosisDrug: Lenalidomide;Drug: Cyclophosphamide;Drug: DexamethasonePETHEMA FoundationNULLCompleted18 YearsN/AAll30Phase 2Spain
26NCT01072773
(ClinicalTrials.gov)
March 201017/2/2010Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain AmyloidosisPhase II Study of Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Light Chain AmyloidosisPrimary Systemic AmyloidosisDrug: bortezomib;Drug: cyclophosphamide;Drug: dexamethasoneMayo ClinicNULLCompleted18 YearsN/AAll2Phase 2United States
27EUCTR2007-006037-13-IT
(EUCTR)
21/02/200810/12/2007An open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - NDAn open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - ND amyloidosis AL
MedDRA version: 6.1;Level: PT;Classification code 10002022
Trade Name: Revlimid
INN or Proposed INN: Cyclophosphamide
INN or Proposed INN: Dexamethasone
OSPEDALE POLICLINICO S. MATTEONULLNot RecruitingFemale: yes
Male: yes
Phase 2Italy
28NCT00981708
(ClinicalTrials.gov)
February 200819/9/2009Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL)A Phase I/II Trial of Lenalidomide Combined With Cyclophosphamide and Intermediate Dose Dexamethasone in Patients With Primary (AL) Systemic AmyloidosisAmyloidosisDrug: Lenalidomide, Dexamethasone and CyclophosphamideUniversity of AthensHellenic Cooperative Oncology GroupCompleted18 YearsN/AAll37Phase 1/Phase 2Greece
29NCT00607581
(ClinicalTrials.gov)
February 200822/1/2008Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL AmyloidosisAn Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL AmyloidosisAmyloidosisDrug: cyclophosphamide;Drug: lenalidomide;Drug: dexamethasoneIRCCS Policlinico S. MatteoCelgene CorporationCompleted18 YearsN/ABoth21Phase 2Italy
30NCT00564889
(ClinicalTrials.gov)
December 200728/11/2007Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic AmyloidosisA Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmDrug: cyclophosphamide;Drug: dexamethasone;Drug: lenalidomideMayo ClinicNational Cancer Institute (NCI)Completed18 YearsN/AAll35Phase 2United States
31EUCTR2006-007082-36-GR
(EUCTR)
16/10/200718/07/2007A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosisA Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosis Primary (AL) amyloidosis in untreated patients or patientsw who have failed prior treatmentsTrade Name: REVLIMID
Trade Name: Endoxan
Trade Name: Dexamethasone
Trade Name: REVLIMID
INN or Proposed INN: Lenalidomide
INN or Proposed INN: Deaxamethasone
INN or Proposed INN: cyclophosphamide
Hellenic Oncology Cooperative GroupNULLNot RecruitingFemale: yes
Male: yes
55Phase 1/2Greece
32EUCTR2006-006395-37-GB
(EUCTR)
06/09/200731/07/2007A randomised, multi-centre feasibility trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients in whom SCT would not be considered appropriate as first line therapy - UK Amyloidosis Treatment Trial (UKATT)A randomised, multi-centre feasibility trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients in whom SCT would not be considered appropriate as first line therapy - UK Amyloidosis Treatment Trial (UKATT) The medical condition to be investigated is systemic AL Amyloidosis, a disorder of protein folding in which normally soluble proteins are deposited as abnormal, insoluble fibrils that progressively disrupt tissue structure and impair function.
MedDRA version: 9.1;Level: LLT;Classification code 10002022;Term: Amyloidosis
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Product Name: Dexamethasone
INN or Proposed INN: DEXAMETHASONE
Product Name: Dexamethasone
INN or Proposed INN: DEXAMETHASONE
Trade Name: Lenogastrim
Other descriptive name: GRANULOCYTE COLONY STIMULATING FACTOR
Product Name: Melphalan
INN or Proposed INN: MELPHALAN
Joint UCLH and UCL Biomedical Research UnitNULLNot Recruiting Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom
33NCT00536601
(ClinicalTrials.gov)
June 29, 200627/9/2007High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid TumorsAutologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid TumorsAdult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Burkitt Lymphoma;Childhood Diffuse Large Cell Lymphoma;Childhood Immunoblastic Large Cell Lymphoma;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET);Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Intraocular Lymphoma;Nodal Marginal Zone B-cell Lymphoma;Peripheral T-cell Lymphoma;Plasma Cell Neoplasm;Primary Systemic Amyloidosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Malignant Testicular Germ Cell Tumor;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Neuroblastoma;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Multiple Myeloma;Regional Neuroblastoma;Splenic Marginal Zone Lymphoma;Testicular Lymphoma;Unspecified Adult Solid Tumor, Protocol Specific;Unspecified Childhood Solid Tumor, Protocol Specific;Waldenström MacroglobulinemiaDrug: etoposide;Drug: cyclophosphamide;Drug: carmustine;Drug: melphalan;Drug: busulfan;Drug: carboplatin;Drug: thiotepa;Radiation: total-body irradiation;Procedure: autologous hematopoietic stem cell transplantation;Procedure: autologous-autologous tandem hematopoietic stem cell transplantationRoswell Park Cancer InstituteNational Cancer Institute (NCI)Completed4 YearsN/AAll174N/AUnited States
34NCT00064337
(ClinicalTrials.gov)
January 20048/7/2003S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic AmyloidosisS0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study)Multiple Myeloma;Plasma Cell MyelomaBiological: filgrastim;Drug: cyclophosphamide;Drug: dexamethasone;Drug: melphalan;Drug: thalidomide;Procedure: peripheral blood stem cell transplantationSouthwest Oncology GroupNational Cancer Institute (NCI)Completed18 Years120 YearsAll104Phase 2United States
35NCT00007995
(ClinicalTrials.gov)
July 19996/1/2001Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic AmyloidosisPhase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Biological: recombinant interferon alfa;Biological: sargramostim;Drug: busulfan;Drug: cyclophosphamide;Drug: melphalan;Procedure: autologous bone marrow transplantation;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantationHerbert Irving Comprehensive Cancer CenterNational Cancer Institute (NCI)Completed18 YearsN/ABoth75Phase 2United States

35. 天疱瘡


臨床試験数 : 99 薬物数 : 124 - (DrugBank : 36) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01974518
(ClinicalTrials.gov)
November 20134/10/2013Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe PemphigusA PILOT STUDY TO ASSESS THE EFFICACY OF RITUXIMAB VERSUS COMBINATION OF RITUXIMAB AND INTRAVENOUS CYCLOPHOSPHAMIDE IN THE TREATMENT OF REFRACTORY PEMPHIGUSPemphigusDrug: Rituximab and Cyclophosphamide IVUprety ShraddhaPostgraduate Institute of Medical Education and ResearchActive, not recruiting18 YearsN/ABoth20Phase 3India
2NCT00483119
(ClinicalTrials.gov)
April 20075/6/2007Randomized Trial of IVIg With or Without Cyclophosphamide in PemphigusPhase 2 Randomized Trial of IVIg With or Without Cyclophosphamide in PemphigusPemphigus VulgarisDrug: intravenous immunoglobulin;Drug: cyclophosphamideNew York University School of MedicineNULLTerminated18 Years85 YearsAll9Phase 2United States
3NCT00278642
(ClinicalTrials.gov)
September 200216/1/2006Hematopoietic Stem Cell Support in Patients With Autoimmune Bullous Skin DisordersHigh Dose Cyclophosphamide & ATG With Hematopoietic Stem Cell Support in Patients With Autoimmune Bullous Skin Disorders: A Phase I TrialPemphigusBiological: Hematopoietic stem cell transplantationRichard Burt, MDNULLTerminated18 Years60 YearsBoth1Phase 1United States
4NCT00010413
(ClinicalTrials.gov)
April 19992/2/2001Phase II Study of High-Dose Cyclophosphamide in Patients With Refractory PemphigusPemphigusDrug: cyclophosphamide;Drug: filgrastimJohns Hopkins UniversityNULLCompleted18 Years70 YearsBoth35Phase 2United States

36. 表皮水疱症


臨床試験数 : 163 薬物数 : 185 - (DrugBank : 46) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 125
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02582775
(ClinicalTrials.gov)
March 201616/10/2015MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCsMT2015-20: Biochemical Correction of Severe Epidermolysis Bullosa by Allogeneic Cell Transplantation and Serial Donor Mesenchymal Cell InfusionsEpidermolysis BullosaProcedure: Bone marrow infusion;Drug: Tacrolimus;Drug: Mycophenolate Mofetil;Biological: Donor mesenchymal stem cell infusions;Drug: Busulfan;Drug: Thymoglobulin;Drug: Cyclophosphamide;Drug: Fludarabine;Radiation: Total Body IrradiationMasonic Cancer Center, University of MinnesotaNULLActive, not recruitingN/A25 YearsAll17Phase 2United States
2NCT01033552
(ClinicalTrials.gov)
January 201014/12/2009Biochemical Correction of Severe EB by Allo HSCT and Off-the-shelf MSCsMT2009-09: Biochemical Correction of Severe Epidermolysis Bullosa by Allogeneic Stem Cell Transplantation and Off-the-shelf Mesenchymal Stem CellsEpidermolysis BullosaDrug: Cyclophosphamide;Drug: Fludarabine;Drug: Anti-thymocyte globulin;Drug: Cyclosporine A;Drug: Mycophenolate mofetil;Procedure: Mesenchymal stem cell transplantation;Radiation: Total body irradiation;Procedure: Bone marrow or umbilical cord blood (UCG) stem cell transplantationMasonic Cancer Center, University of MinnesotaNULLCompletedN/A25 YearsAll32Phase 1/Phase 2United States
3NCT00478244
(ClinicalTrials.gov)
April 200723/5/2007Allogeneic Hematopoietic Stem Cell Transplant For Epidermolysis BullosaAllogeneic Hematopoietic Cell Transplantation to Correct the Biochemical Defect and Create Tolerance to Donor Tissue in Subjects With Epidermolysis BullosaEpidermolysis BullosaDrug: busulfan;Drug: cyclophosphamide;Drug: fludarabine phosphate;Procedure: hematopoietic bone marrow transplantationMasonic Cancer Center, University of MinnesotaNULLTerminatedN/A25 YearsAll7N/AUnited States

40. 高安動脈炎


臨床試験数 : 24 薬物数 : 40 - (DrugBank : 18) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 110
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03550781
(ClinicalTrials.gov)
June 1, 20185/5/2018Anti-inflammatory Treatment for Inactive Takayasu ArteritisDoes Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment?Takayasu Arteritis;Anti-Inflammatory AgentsDrug: Prednisone, cyclophosphamideChinese Academy of Medical Sciences, Fuwai HospitalNULLNot yet recruiting10 Years40 YearsAll40Phase 2/Phase 3NULL
2NCT03096275
(ClinicalTrials.gov)
March 16, 201713/3/2017Comparison of Mycophenolate Mofetil and Cyclophosphamide for Active Takayasu's ArteritisComparison of the Efficacy of Mycophenolate Mofetil Combined With Methotrexate and Cyclophosphamide for the Treatment of Takayasu's ArteritisTakayasu ArteritisDrug: MMF;Drug: CYC;Drug: Glucocorticoids;Drug: MTX;Drug: AZAChinese SLE Treatment And Research GroupPeking Union Medical College HospitalActive, not recruiting18 YearsN/AAll138Phase 3China
3NCT00006055
(ClinicalTrials.gov)
March 20005/7/2000Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune DiseasesPurpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu ArteritisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell TransplantationFairview University Medical CenterNULLActive, not recruiting1 Year55 YearsBoth10N/AUnited States

41. 巨細胞性動脈炎


臨床試験数 : 131 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00006055
(ClinicalTrials.gov)
March 20005/7/2000Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune DiseasesPurpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu ArteritisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell TransplantationFairview University Medical CenterNULLActive, not recruiting1 Year55 YearsBoth10N/AUnited States

42. 結節性多発動脈炎


臨床試験数 : 15 薬物数 : 26 - (DrugBank : 16) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 105
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-004668-71-ES
(EUCTR)
13/10/201605/08/2016A study of treatment for polyarteritis nodosa in childrenAn Open Label Randomised Controlled Trial of Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission of Childhood Polyarteritis Nodosa - MYPAN Childhood systemic polyarteritis nodosa (PAN)
MedDRA version: 19.0;Level: LLT;Classification code 10036026;Term: Polyarteritis nodosa of childhood;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept (Mycophenolate Mofetil)
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
University College LondonNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Belgium;Poland;Croatia;Germany;Netherlands;Sweden
2EUCTR2013-004668-71-IT
(EUCTR)
01/08/201614/07/2015An Open Label Randomised Controlled Trial of Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission of Childhood Polyarteritis Nodosa - MYPAN An Open Label Randomised Controlled Trial of Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission of Childhood Polyarteritis Nodosa - MYPAN Childhood systemic polyarteritis nodosa (PAN)
MedDRA version: 19.0;Level: LLT;Classification code 10036026;Term: Polyarteritis nodosa of childhood;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept (Mycophenolate Mofetil)
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
University College LondonNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Belgium;Poland;Croatia;Germany;Netherlands;Sweden
3EUCTR2013-004668-71-GB
(EUCTR)
25/09/201425/09/2014A study of treatment for polyarteritis nodosa in childrenAn Open Label Randomised Controlled Trial of Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission of Childhood Polyarteritis Nodosa - MYPAN Childhood systemic polyarteritis nodosa (PAN)
MedDRA version: 17.0;Level: LLT;Classification code 10036026;Term: Polyarteritis nodosa of childhood;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept (Mycophenolate Mofetil)
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
University College LondonNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Croatia;Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Belgium;Poland;Germany;Netherlands;Sweden
4NCT00751517
(ClinicalTrials.gov)
September 200811/9/2008Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing VasculitidesCyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis;Polyarteritis NodosaDrug: Methotrexate;Drug: CyclophosphamideUniversity of ParmaNULLActive, not recruiting18 Years80 YearsBothPhase 2Italy
5NCT00307671
(ClinicalTrials.gov)
July 200527/3/2006Treatment of Necrotizing Vasculitides for Patients Older Than 65 YearsTreatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without ImmunosuppressantsVasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Polyarteritis NodosaDrug: prednisone, methylprednisolone,cyclophosphamides;Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone;Drug: Mycophenolate mofetil,methotrexateAssistance Publique - Hôpitaux de ParisNULLCompleted65 YearsN/ABoth108Phase 4France
6NCT00006055
(ClinicalTrials.gov)
March 20005/7/2000Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune DiseasesPurpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu ArteritisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell TransplantationFairview University Medical CenterNULLActive, not recruiting1 Year55 YearsBoth10N/AUnited States
7NCT00400075
(ClinicalTrials.gov)
July 199614/11/2006CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis FactorsCHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 PatientsPolyarteritis Nodosa;Microscopic PolyangiitisDrug: azathioprine;Drug: cyclophosphamideHospices Civils de LyonNULLActive, not recruiting15 Years90 YearsBoth124Phase 4Switzerland
8EUCTR2013-004668-71-BE
(EUCTR)
12/04/2017A study of treatment for polyarteritis nodosa in childrenAn Open Label Randomised Controlled Trial of Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission of Childhood Polyarteritis Nodosa - MYPAN Childhood systemic polyarteritis nodosa (PAN)
MedDRA version: 19.1;Level: LLT;Classification code 10036026;Term: Polyarteritis nodosa of childhood;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept (Mycophenolate Mofetil)
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
INN or Proposed INN: CYCLOPHOSPHAMIDE
University College LondonNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Belgium;Poland;Croatia;Germany;Netherlands;Sweden
9EUCTR2013-004668-71-PT
(EUCTR)
16/02/2016A study of treatment for polyarteritis nodosa in childrenAn Open Label Randomised Controlled Trial of Mycophenolate Mofetil Versus Cyclophosphamide for the Induction of Remission of Childhood Polyarteritis Nodosa - MYPAN Childhood systemic polyarteritis nodosa (PAN)
MedDRA version: 18.1;Level: LLT;Classification code 10036026;Term: Polyarteritis nodosa of childhood;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: CellCept (Mycophenolate Mofetil)
Product Name: CellCept (Mycophenolate Mofetil)
INN or Proposed INN: Mycophenolate mofetil
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
University College LondonNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Portugal;Slovenia;Greece;Spain;Turkey;United Kingdom;Italy;Czech Republic;Belgium;Poland;Croatia;Germany;Netherlands;Sweden

43. 顕微鏡的多発血管炎


臨床試験数 : 88 薬物数 : 81 - (DrugBank : 21) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 90
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000024574
2018/07/0201/05/2017Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitisClinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis - AAVTCZ Microscopic polyangiitis (MPA)Granulomatosis with polyangiitis (GPA)TCZ group
Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks.
Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks.
If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24.
Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48.

PSL
PSL will be prescribed by the same schedule to both treatment groups.
Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule.
Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day.


IVCY group
Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times).
From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52.

PSL
PSL will be prescribed by the same schedule to both treatment groups.
Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule.
Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day.
Tokyo women's medical universityInstitute of rheumatologyHokkaido university hospitalSaitama medical centerTokyo women's medical university hospitalKeio university hospitalJuntendo university hospitalKyorin university hospitalSt. Marianna university hospitalOkayama university hospitalKagawa university hospitalHospital of the university of occupational and environmental health, JapanTokyo Medical CenterTouhoku University HospitalKyusyu University HospitalHiroshima University HospitalRecruiting20years-old85years-oldMale and Female48Phase 2Japan
2JPRN-JMA-IIA00325
01/07/201823/01/2018Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitisClinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis Microscopic polyangiitis (MPA) Granulomatosis with polyangiitis (GPA)Intervention type:DRUG. Intervention1:remission induction therapy, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen:Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks.
Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks.
If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24.
Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48.
. Control intervention1:Cyclophosphamide (CY), Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, Intended dose regimen:Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times).
From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52.
PSL will be prescribed by the same schedule to both treatment groups.
Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule.
Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day..
Masayoshi HarigaiNULLPending>=20 YEARS<80 YEARSBOTH48Phase 2Japan
3EUCTR2016-001121-14-NO
(EUCTR)
06/10/201707/02/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;New Zealand;Sweden
4EUCTR2016-001121-14-NL
(EUCTR)
15/06/201718/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
5EUCTR2016-001121-14-BE
(EUCTR)
08/05/201706/02/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
6EUCTR2016-001121-14-IT
(EUCTR)
04/05/201707/01/2021A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCAAssociated Vasculitis (AAV).Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Trade Name: Prednison acis¿ 5 mg
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Trade Name: Prednison acis¿ 20 mg
CHEMOCENTRYX, INC.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
7EUCTR2016-001121-14-HU
(EUCTR)
24/04/201723/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
8EUCTR2016-001121-14-DK
(EUCTR)
07/04/201701/02/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden
9EUCTR2016-001121-14-GB
(EUCTR)
06/04/201723/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Hungary;United States;United Kingdom;Switzerland;Spain;New Zealand;Canada;Austria;Czech Republic;Netherlands;Sweden;Belgium;Norway;Ireland;Denmark;Italy;Australia;France;Germany
10EUCTR2016-001121-14-ES
(EUCTR)
21/03/201720/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
11EUCTR2016-001121-14-CZ
(EUCTR)
20/03/201712/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
12EUCTR2016-001121-14-AT
(EUCTR)
13/02/201710/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: prednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
13EUCTR2016-001121-14-SE
(EUCTR)
13/02/201721/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
14JPRN-UMIN000011244
2013/09/0101/09/2013A prospective, open label, randomized, controlled trial of tocilizumab versus cyclophosphamide in patients with microscopic polyangiitisA prospective, open label, randomized, controlled trial of tocilizumab versus cyclophosphamide in patients with microscopic polyangiitis - Tocilizumab versus cyclophosphamide in microscopic polyangiitis Microscopic polyangiitisTocilizumab group
Cyclophosphamide group
Saitama Medical Center, Saitama Medical UniversityDepartment of Rheumatology and Clinical ImmunologyNULLComplete: follow-up complete20years-old80years-oldMale and Female40Not selectedJapan
15NCT00751517
(ClinicalTrials.gov)
September 200811/9/2008Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing VasculitidesCyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis;Polyarteritis NodosaDrug: Methotrexate;Drug: CyclophosphamideUniversity of ParmaNULLActive, not recruiting18 Years80 YearsBothPhase 2Italy
16EUCTR2006-001663-33-IT
(EUCTR)
09/06/200828/05/2008A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYCA randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC ANCA-associated vasculitis (Microscopic Polyangiitis, Wegener's granulomatosis)
MedDRA version: 9.1;Level: HLT;Classification code 10047113;Term: Vasculitides NEC
Trade Name: CELLCEPT
INN or Proposed INN: Mycophenolic acid
Trade Name: ENDOXAN BAXTER
INN or Proposed INN: Cyclophosphamide
Vasculitis and Lupus ClinicNULLNot RecruitingFemale: yes
Male: yes
140France;Spain;Austria;Germany;United Kingdom;Italy;Sweden
17EUCTR2006-001663-33-SE
(EUCTR)
13/05/200819/03/2008A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYCA randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC Anti neutrophil cytoplasmic antibody (ANCA) associated vasculitis. Wegener´s granulomatosis (WG) and microscopic polyangiitis (MPA) are primary systemic vasculitides associated with ANCATrade Name: Cellcept
Product Name: Cellcept
Product Code: Ro106-1443
INN or Proposed INN: Mycophenolate mofetil
Trade Name: Sendoxan
Product Name: Sendoxan
Product Code: 5009111000001105
INN or Proposed INN: CYCLOPHOSPHAMIDE
Cambridge University Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
140Phase 2France;Czech Republic;Spain;Austria;Germany;Italy;United Kingdom;Sweden
18EUCTR2005-003610-15-CZ
(EUCTR)
29/08/200623/02/2006An international, randomised, open label trial comparing a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, ‘generalised’ ANCA associated vasculitis. - RITUXVASAn international, randomised, open label trial comparing a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, ‘generalised’ ANCA associated vasculitis. - RITUXVAS The ANCA associated vasculitides (AASV), namely Wegener’s granulomatosis, microscopic polyangiitis, and renal limited vasculitis.INN or Proposed INN: RituximabAddenbrooke's Hospital, Cambridge University Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
66Phase 3Czech Republic;United Kingdom;Sweden
19NCT00307671
(ClinicalTrials.gov)
July 200527/3/2006Treatment of Necrotizing Vasculitides for Patients Older Than 65 YearsTreatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without ImmunosuppressantsVasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Polyarteritis NodosaDrug: prednisone, methylprednisolone,cyclophosphamides;Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone;Drug: Mycophenolate mofetil,methotrexateAssistance Publique - Hôpitaux de ParisNULLCompleted65 YearsN/ABoth108Phase 4France
20NCT00104299
(ClinicalTrials.gov)
January 200524/2/2005Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic PolyangiitisRituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI)Vasculitis;Wegener's Granulomatosis;Microscopic PolyangiitisDrug: Rituximab plus cyclophosphamide placebo (rituximab group);Drug: Cyclophosphamide plus rituximab placebo (control group);Drug: Azathioprine;Drug: Methylprednisolone (or other glucocorticoid);Drug: PrednisoneNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN);Genentech, Inc.Completed15 YearsN/AAll197Phase 2/Phase 3United States;Netherlands
21NCT00103792
(ClinicalTrials.gov)
December 200414/2/2005Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA)Comparative Study of the Efficacy of Induction Therapy With Cyclophosphamide or Mycophenolate Mofetil for Non-Life-Threatening Relapses of PR3- or MPO-ANCA Associated VasculitisWegener's Granulomatosis;VasculitisDrug: mycophenolate mofetil;Drug: cyclophosphamideUniversity Medical Centre GroningenNULLRecruiting18 YearsN/ABoth90Phase 3Netherlands
22NCT00307645
(ClinicalTrials.gov)
May 200327/3/2006IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic VasculitisMycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic VasculitisANCA Associated Systemic Vasculitis Including Wegener’s;Granulomatosis and Microscopic Polyangiitis and;Renal Limited VasculitisDrug: Cyclophosphamide;Drug: Mycophenolate mofetil;Drug: Azathioprine;Drug: Prednisone (and methylprednisolone)Assistance Publique - Hôpitaux de ParisNULLTerminated18 YearsN/ABoth160Phase 3France;United Kingdom
23NCT00753103
(ClinicalTrials.gov)
January 200315/9/2008Anti-Cytokine Therapy for VasculitisPhase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated VasculitisWegener's Granulomatosis;Renal Limited Vasculitis;Microscopic PolyangiitisBiological: Infliximab;Drug: Cyclophosphamide;Drug: Prednisolone;Drug: Azathioprine;Procedure: Plasma exchange;Drug: Mycophenolate mofetil;Drug: MethylprednisoloneUniversity Hospital Birmingham NHS Foundation TrustNULLCompleted18 YearsN/ABoth37Phase 2United Kingdom
24NCT00430105
(ClinicalTrials.gov)
February 199831/1/2007Pulse Versus Continuous Cyclophosphamide for Induction of Remission in ANCA-Associated VasculitidesRandomized Trial of Intravenous Pulse Versus Oral Continuous Cyclophosphamide for Induction of Remission in Systemic ANCA-Associated VasculitidesANCA Associated Systemic Vasculitis;Wegener's Granulomatosis;Microscopic PolyangiitisDrug: cyclophosphamideCambridge University Hospitals NHS Foundation TrustNULLCompleted18 Years80 YearsBoth160Phase 2/Phase 3NULL
25NCT00400075
(ClinicalTrials.gov)
July 199614/11/2006CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis FactorsCHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 PatientsPolyarteritis Nodosa;Microscopic PolyangiitisDrug: azathioprine;Drug: cyclophosphamideHospices Civils de LyonNULLActive, not recruiting15 Years90 YearsBoth124Phase 4Switzerland
26EUCTR2016-001121-14-FR
(EUCTR)
22/06/2018A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
27EUCTR2016-001121-14-DE
(EUCTR)
23/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 21.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
28EUCTR2016-001121-14-IE
(EUCTR)
21/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

44. 多発血管炎性肉芽腫症


臨床試験数 : 98 薬物数 : 108 - (DrugBank : 28) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 81
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000024574
2018/07/0201/05/2017Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitisClinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis - AAVTCZ Microscopic polyangiitis (MPA)Granulomatosis with polyangiitis (GPA)TCZ group
Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks.
Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks.
If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24.
Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48.

PSL
PSL will be prescribed by the same schedule to both treatment groups.
Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule.
Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day.


IVCY group
Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times).
From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52.

PSL
PSL will be prescribed by the same schedule to both treatment groups.
Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule.
Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day.
Tokyo women's medical universityInstitute of rheumatologyHokkaido university hospitalSaitama medical centerTokyo women's medical university hospitalKeio university hospitalJuntendo university hospitalKyorin university hospitalSt. Marianna university hospitalOkayama university hospitalKagawa university hospitalHospital of the university of occupational and environmental health, JapanTokyo Medical CenterTouhoku University HospitalKyusyu University HospitalHiroshima University HospitalRecruiting20years-old85years-oldMale and Female48Phase 2Japan
2JPRN-JMA-IIA00325
01/07/201823/01/2018Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitisClinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis Microscopic polyangiitis (MPA) Granulomatosis with polyangiitis (GPA)Intervention type:DRUG. Intervention1:remission induction therapy, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen:Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks.
Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks.
If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24.
Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48.
. Control intervention1:Cyclophosphamide (CY), Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, Intended dose regimen:Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times).
From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52.
PSL will be prescribed by the same schedule to both treatment groups.
Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule.
Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day..
Masayoshi HarigaiNULLPending>=20 YEARS<80 YEARSBOTH48Phase 2Japan
3EUCTR2016-001121-14-NO
(EUCTR)
06/10/201707/02/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;New Zealand;Sweden
4EUCTR2016-001121-14-NL
(EUCTR)
15/06/201718/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
5EUCTR2016-001121-14-BE
(EUCTR)
08/05/201706/02/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
6EUCTR2016-001121-14-IT
(EUCTR)
04/05/201707/01/2021A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCAAssociated Vasculitis (AAV).Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Trade Name: Prednison acis¿ 5 mg
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Trade Name: Prednison acis¿ 20 mg
CHEMOCENTRYX, INC.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Czechia;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
7EUCTR2016-001121-14-HU
(EUCTR)
24/04/201723/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
8EUCTR2016-001121-14-DK
(EUCTR)
07/04/201701/02/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden
9EUCTR2016-001121-14-GB
(EUCTR)
06/04/201723/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Hungary;United States;United Kingdom;Switzerland;Spain;New Zealand;Canada;Austria;Czech Republic;Netherlands;Sweden;Belgium;Norway;Ireland;Denmark;Italy;Australia;France;Germany
10EUCTR2016-001121-14-ES
(EUCTR)
21/03/201720/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.1;Classification code 10063344;Term: Microscopic polyangiitis;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
11EUCTR2016-001121-14-CZ
(EUCTR)
20/03/201712/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
12EUCTR2016-001121-14-SE
(EUCTR)
13/02/201721/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
13EUCTR2016-001121-14-AT
(EUCTR)
13/02/201710/01/2017A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: prednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
14NCT02807103
(ClinicalTrials.gov)
December 5, 201620/5/2016Rituximab in Eosinophilic Granulomatosis With PolyangiitisEvaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind StudyEosinophilic Granulomatosis With Polyangiitis (EGPA)Drug: Rituximab;Drug: Placebo-rituximab;Drug: Cyclophosphamide;Drug: Placebo-cyclophosphamideAssistance Publique - Hôpitaux de ParisFrench Vasculitis Study GroupCompleted18 YearsN/AAll107Phase 3France
15EUCTR2016-000275-25-FR
(EUCTR)
21/03/201613/04/2016Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVASEvaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVAS Patients with a diagnosis of EGPA with newly-diagnosed disease or with a relapsing disease at the time of screening
MedDRA version: 19.0;Level: PT;Classification code 10048594;Term: Allergic granulomatous angiitis;System Organ Class: 10021428 - Immune system disorders
Trade Name: RITUXIMAB
Product Name: RITUXIMAB
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: CYCLOPHOSPHAMIDE
Product Name: CYCLOPHOSPHAMIDE
INN or Proposed INN: CYCLOPHOSPHAMIDE
Trade Name: MESNA
Product Name: MESNA
INN or Proposed INN: mesna
Other descriptive name: MESNA
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
108Phase 3France
16EUCTR2011-001219-30-DE
(EUCTR)
17/01/201220/06/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) Relapse of Wegener’s Granulomatosis
MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
INN or Proposed INN: gusperimus
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
INN or Proposed INN: cyclophosphamide
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
INN or Proposed INN: azathioprine
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
INN or Proposed INN: methotrexate
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
INN or Proposed INN: methotrexate
Nordic Pharma SASNULLNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
17EUCTR2011-001219-30-GB
(EUCTR)
08/11/201112/07/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) Relapse of Wegener’s Granulomatosis
MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
INN or Proposed INN: gusperimus
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
INN or Proposed INN: cyclophosphamide
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
INN or Proposed INN: azathioprine
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
INN or Proposed INN: methotrexate
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
INN or Proposed INN: methotrexate
Nordic Pharma SASNULLNot Recruiting Female: yes
Male: yes
216 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
18NCT01446211
(ClinicalTrials.gov)
November 201120/9/2011Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus Versus Conventional Therapy in Relapse of Granulomatosis With Polyangiitis (Wegener's Granulomatosis) SPARROW Study - SPAnidin in Relapsing GRanulomatosis With POlyangiitis Wegener's Granulomatosis)Wegeners GranulomatosisDrug: Gusperimus + glucocorticoids;Drug: cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoidsNordic Pharma SASNULLTerminated18 Years75 YearsBoth4Phase 3Czech Republic
19EUCTR2011-001219-30-ES
(EUCTR)
14/10/201104/07/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener?s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener?s Granulomatosis) - SPARROW study ? SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener?s granulomatosis) Relapse of Wegener?s Granulomatosis
MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
INN or Proposed INN: gusperimus
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
INN or Proposed INN: cyclophosphamide
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
INN or Proposed INN: azathioprine
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
INN or Proposed INN: methotrexate
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
INN or Proposed INN: methotrexate
Nordic Pharma FranceNULLNot RecruitingFemale: yes
Male: yes
216United Kingdom;Slovakia;Russian Federation;Germany;Czech Republic;Netherlands;France;Spain;Italy;United States;Sweden
20EUCTR2011-001219-30-SK
(EUCTR)
28/09/201105/10/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) Relapse of Wegener’s Granulomatosis
MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
INN or Proposed INN: gusperimus
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
INN or Proposed INN: cyclophosphamide
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
INN or Proposed INN: azathioprine
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
INN or Proposed INN: methotrexate
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
INN or Proposed INN: methotrexate
Nordic Pharma SASNULLNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
21EUCTR2011-001219-30-SE
(EUCTR)
31/08/201121/06/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) Relapse of Wegener’s Granulomatosis
MedDRA version: 13.1;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 13.1;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
INN or Proposed INN: gusperimus
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
INN or Proposed INN: cyclophosphamide
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
INN or Proposed INN: azathioprine
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
INN or Proposed INN: methotrexate
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
INN or Proposed INN: methotrexate
Nordic Pharma FranceNULLNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
22EUCTR2011-001219-30-CZ
(EUCTR)
18/08/201120/06/2011Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s GranulomatosisRandomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) Relapse of Wegener’s Granulomatosis
MedDRA version: 13.1;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 13.1;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Gusperimus
INN or Proposed INN: gusperimus
Trade Name: Endoxan® 500 mg
Product Name: Cyclophosphamidum 500 mg
INN or Proposed INN: cyclophosphamide
Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten
Product Name: Azathioprine 25 mg
INN or Proposed INN: azathioprine
Trade Name: Metex 2,5 mg Tabletten
Product Name: Methotrexate 2.5 mg
INN or Proposed INN: methotrexate
Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie
Product Name: Methotrexate 25 mg
INN or Proposed INN: methotrexate
Nordic Pharma FranceNULLNot RecruitingFemale: yes
Male: yes
216France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden
23EUCTR2016-001121-14-DE
(EUCTR)
23/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 21.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 21.1;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
24EUCTR2016-001121-14-IE
(EUCTR)
21/12/2016A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
25EUCTR2016-001121-14-FR
(EUCTR)
22/06/2018A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Avacopan
Product Code: CCX168
INN or Proposed INN: Avacopan
Other descriptive name: CCX168
Trade Name: Prednison acis® 5 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
Trade Name: Prednison acis® 20 mg
INN or Proposed INN: Pednisone
Other descriptive name: PREDNISONE
ChemoCentryx, Inc.NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden

45. 好酸球性多発血管炎性肉芽腫症


臨床試験数 : 31 薬物数 : 44 - (DrugBank : 18) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 101
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02807103
(ClinicalTrials.gov)
December 5, 201620/5/2016Rituximab in Eosinophilic Granulomatosis With PolyangiitisEvaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind StudyEosinophilic Granulomatosis With Polyangiitis (EGPA)Drug: Rituximab;Drug: Placebo-rituximab;Drug: Cyclophosphamide;Drug: Placebo-cyclophosphamideAssistance Publique - Hôpitaux de ParisFrench Vasculitis Study GroupCompleted18 YearsN/AAll107Phase 3France
2EUCTR2016-000275-25-FR
(EUCTR)
21/03/201613/04/2016Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVASEvaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVAS Patients with a diagnosis of EGPA with newly-diagnosed disease or with a relapsing disease at the time of screening
MedDRA version: 19.0;Level: PT;Classification code 10048594;Term: Allergic granulomatous angiitis;System Organ Class: 10021428 - Immune system disorders
Trade Name: RITUXIMAB
Product Name: RITUXIMAB
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: CYCLOPHOSPHAMIDE
Product Name: CYCLOPHOSPHAMIDE
INN or Proposed INN: CYCLOPHOSPHAMIDE
Trade Name: MESNA
Product Name: MESNA
INN or Proposed INN: mesna
Other descriptive name: MESNA
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNot RecruitingFemale: yes
Male: yes
108Phase 3France
3NCT00751517
(ClinicalTrials.gov)
September 200811/9/2008Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing VasculitidesCyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis;Polyarteritis NodosaDrug: Methotrexate;Drug: CyclophosphamideUniversity of ParmaNULLActive, not recruiting18 Years80 YearsBothPhase 2Italy
4NCT00307671
(ClinicalTrials.gov)
July 200527/3/2006Treatment of Necrotizing Vasculitides for Patients Older Than 65 YearsTreatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without ImmunosuppressantsVasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Polyarteritis NodosaDrug: prednisone, methylprednisolone,cyclophosphamides;Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone;Drug: Mycophenolate mofetil,methotrexateAssistance Publique - Hôpitaux de ParisNULLCompleted65 YearsN/ABoth108Phase 4France
5NCT00006055
(ClinicalTrials.gov)
March 20005/7/2000Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune DiseasesPurpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu ArteritisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell TransplantationFairview University Medical CenterNULLActive, not recruiting1 Year55 YearsBoth10N/AUnited States
6NCT00399399
(ClinicalTrials.gov)
July 199613/11/2006CHUSPAN SCS BP Treatment of Churg–Strauss Syndrome Without Poor-Prognosis FactorsCHUSPAN SCS BP Treatment of Churg–Strauss Syndrome Without Poor-Prognosis Factors: a Prospective Randomized Study in 72 Patients.Churg-Strauss SyndromeDrug: azathioprine;Drug: cyclophosphamideHospices Civils de LyonNULLActive, not recruiting15 Years90 YearsBoth72Phase 4Switzerland

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02693210
(ClinicalTrials.gov)
February 200123/2/2016A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid ArthritisA Randomised, Double Dummy Controlled, Parallel Group Study of the Efficacy and Safety of MabThera (Rituximab) Alone or in Combination With Either Cyclophosphamide or Methotrexate, in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Cyclophosphamide;Drug: Methotrexate;Other: Placebo Cyclophosphamide;Other: Placebo Methotrexate;Other: Placebo Rituximab;Drug: RituximabHoffmann-La RocheNULLCompleted21 YearsN/ABoth161Phase 2Australia;Belgium;Canada;Czech Republic;Germany;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
2NCT00006055
(ClinicalTrials.gov)
March 20005/7/2000Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune DiseasesPurpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu ArteritisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell TransplantationFairview University Medical CenterNULLActive, not recruiting1 Year55 YearsBoth10N/AUnited States

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05666336
(ClinicalTrials.gov)
December 31, 20228/12/2022Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE PatientsProteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus ErythematosusSystemic Lupus ErythematosusBiological: Telitacicept;Drug: Hydroxychloroquine;Drug: Prednisone;Drug: Methylprednisolone;Drug: Cyclophosphamide;Drug: Mycophenolate Mofetil;Drug: TacrolimusFen LiNULLNot yet recruiting18 Years75 YearsAll30Phase 4NULL
2ITMCTR2100005063
2021-07-152021-07-16A prospective non-randomized controlled study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosusA prospective cohort study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus Systemic lupus erythematosusExperimental group:Western medicine + Jiedu Quyu Zishen Fang's modified treatment based on syndrome differentiation;Control Group:Western Medicine (glucocorticoid, hydroxychloroquine, methotrexate, azathioprine or cyclophosphamide);Zhejiang Chinese Medical UniversityNULLPending1865FemaleExperimental group:264;Control Group:264;N/AChina
3ChiCTR2100048796
2021-07-152021-07-16A prospective non-randomized controlled study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosusA prospective cohort study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus Systemic lupus erythematosusExperimental group:Western medicine + Jiedu Quyu Zishen Fang's modified treatment based on syndrome differentiation;Control Group:Western Medicine (glucocorticoid, hydroxychloroquine, methotrexate, azathioprine or cyclophosphamide);Zhejiang Chinese Medical UniversityNULLPending1865FemaleExperimental group:264;Control Group:264;N/AChina
4ChiCTR2200055471
2021-01-012022-01-10Efficacy and safety of low-dose CTX combined with belimumab based on B/T cell balance in the treatment of moderate to severe systemic lupus erythematosus: a medical record-based studyEfficacy and safety of low-dose CTX combined with belimumab based on B/T cell balance in the treatment of moderate to severe systemic lupus erythematosus Systemic Lupus Erythematosus (SLE)belimumab group:Low-dose cyclophosphamide combined with belimumab;cyclophosphamide group:Standard dose cyclophosphamide;The Second Hospital of Shanxi Medical UniversityNULLRecruiting1880Bothbelimumab group:40;cyclophosphamide group:42;China
5NCT03492255
(ClinicalTrials.gov)
April 12, 201816/3/2018CYCLONES - CYClophosphamide LOw Dose and No Extra SteroidCYCLONES - CYClophosphamide LOw Dose and No Extra SteroidSystemic Lupus Erythematosus (SLE)Drug: Cyclophosphamide;Drug: Methylprednisolone;Drug: Prednisone;Drug: Mycophenolate MofetilUniversity of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloTerminated18 YearsN/AAll49N/ABrazil
6NCT03030976
(ClinicalTrials.gov)
March 201722/1/2017A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE)An Open-labeled, Uncontrolled, Single-arm Pilot Study to Evaluate Cellular Immunotherapy Using CD19-targeted Chimeric Antigen Receptor Engineered T Cells in Patients With CD19+ B Cell Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus (SLE)Drug: cyclophosphamide;Drug: anti-CD19-CAR-T cellsShanghai GeneChem Co., Ltd.RenJi HospitalRecruiting18 Years69 YearsAll5Phase 1China
7NCT02080195
(ClinicalTrials.gov)
September 13, 201628/2/2014Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)A Phase I/II Study of Nonmyeloablative Conditioning and Transplantation of Human Leukocyte Antigen (HLA)-Matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated Bone Marrow for Patients With Refractory SLELupus Erythematosus;Graft-versus-host DiseaseDrug: Cyclophosphamide;Drug: Fludarabine;Drug: Tacrolimus;Drug: Mycophenolate Mofetil;Drug: Rabbit antithymocyte globulin;Radiation: Total body irradiation;Biological: Allogeneic bone marrow transplantSidney Kimmel Comprehensive Cancer Center at Johns HopkinsMaryland Stem Cell Research FundTerminated18 Years75 YearsAll1Phase 1/Phase 2United States
8ChiCTR-ONC-15007547
2015-12-052015-12-04Clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus: a multicenter prospective cohort studyStudy of the clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus systemic lupus erythematosusThe combination of Chinese and western group:Traditional Chinese medicine combined western medicine;Treating by Western Medicine group:Treating by Western medicine (sugar cortical hormone, hydroxychloroquine, and methotrexate, azathioprine, or cyclophosphamide);Zhejiang Chinese Medical UniversityNULLRecruiting1860BothThe combination of Chinese and western group:264;Treating by Western Medicine group:264;China
9NCT02444728
(ClinicalTrials.gov)
July 201512/5/2015Cyclophosphamide and Hydroxychloroquine for Thrombocytopenia in SLECyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus ErythematosusThrombocytopeniaDrug: Hydroxychloroquine;Drug: Cyclophosphamide;Drug: Azathioprine;Drug: MethylprednisoloneChinese SLE Treatment And Research GroupPeking Union Medical College HospitalRecruiting18 Years70 YearsAll220Phase 3China
10NCT01689350
(ClinicalTrials.gov)
October 201217/9/2012A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus TreatmentProspective Study Based on Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus TreatmentSystemic Lupus ErythematosusGenetic: Genotype DetectionSun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen UniversityCompleted12 Years60 YearsAll92N/AChina
11NCT01060410
(ClinicalTrials.gov)
May 20101/2/2010Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus TreatmentExploration of Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus TreatmentLupus Erythematosus, Systemic;Adverse EffectsGenetic: Polymorphism Analysis;Drug: Cyclophosphamide;Other: Pharmacokinetic analysisSun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen UniversityCompleted12 Years80 YearsBoth222N/AChina
12NCT00626197
(ClinicalTrials.gov)
February 200820/2/2008A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus ErythematosusLupus Nephritis;Systemic Lupus ErythematosusDrug: corticosteroids;Drug: cyclophosphamide;Drug: mycophenolate mofetil;Drug: ocrelizumab;Drug: placeboGenentech, Inc.Roche Pharma AGCompleted16 YearsN/AAll381Phase 3United States
13EUCTR2005-003957-28-DK
(EUCTR)
21/12/200620/11/2006FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMISEDACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILESYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS: ORALCYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUSCYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUSCYCLOPHOSPHAMIDEFIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMISEDACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILESYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS: ORALCYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUSCYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUSCYCLOPHOSPHAMIDE SYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS
MedDRA version: 8.1;Level: LLT;Classification code 10029142;Term: Nephritis systemic lupus erythematosus
Product Name: Cyclophosphamide
Product Name: Cyclophosphamide
Istituto Giannina GasliniNULLNot RecruitingFemale: yes
Male: yes
141Phase 3Denmark;Italy
14NCT00336414
(ClinicalTrials.gov)
June 200612/6/2006Five-Year Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus NephritisFive-Year Single-Blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis: Oral Cyclophosphamide Versus High Dose Intravenous Cyclophosphamide Versus Intermediate Dose Intravenous CyclophosphamideSystemic Lupus Erythematosus NephritisDrug: cyclophosphamide-prednisone-azathioprineIstituto Giannina GasliniNULLWithdrawn1 Year18 YearsAll0Phase 3Italy
15EUCTR2005-003957-28-IT
(EUCTR)
02/05/200609/05/2006FIVE-YEAR SINGLE-BLIND, PHASE II EFFECTIVENESS RANDOMISED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE SYSTEMIC LUPUS ERYTHEMATOSUS NEPHTRITIS ORAL CYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUS CYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUS CYCLOPHOSPHAMIDE. - NDFIVE-YEAR SINGLE-BLIND, PHASE II EFFECTIVENESS RANDOMISED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE SYSTEMIC LUPUS ERYTHEMATOSUS NEPHTRITIS ORAL CYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUS CYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUS CYCLOPHOSPHAMIDE. - ND New onset juvenile sistemic lupus erythematosus nephritis
MedDRA version: 6.1;Level: PT;Classification code 10025140
INN or Proposed INN: Azathioprine
INN or Proposed INN: Methylprednisolone
INN or Proposed INN: Prednisone
INN or Proposed INN: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide
ISTITUTO GIANNINA GASLININULLNot RecruitingFemale: yes
Male: yes
141Phase 3Belgium;Denmark;Italy
16NCT00278538
(ClinicalTrials.gov)
September 23, 200515/1/2006Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus ErythematosusCyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus: Phase II TrialSystemic Lupus ErythematosusBiological: Hematopoietic stem cell transplantationNorthwestern UniversityNULLCompleted15 Years60 YearsAll32Phase 2United States
17NCT00094380
(ClinicalTrials.gov)
September 200416/10/2004Treating Systemic Lupus Erythematosus (SLE) Patients With CTLA4-IgG4m (RG2077)Treatment of Systemic Lupus Erythematosus With CTLA4-IgG4m Plus Cyclophosphamide: A Phase I/IIA StudyLupus Erythematosus, Systemic;Lupus NephritisDrug: CTLA4-IgG4m (RG2077);Drug: CyclophosphamideNational Institute of Allergy and Infectious Diseases (NIAID)Immune Tolerance Network (ITN)Completed18 YearsN/AAll6Phase 1/Phase 2United States
18NCT00076752
(ClinicalTrials.gov)
January 30, 20042/2/2004Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus ErythematosusA Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: fludarabine phosphate;Drug: cyclophosphamide;Biological: Rituxan (rituximab);Biological: filgrastim;Drug: methylprednisolone;Other: immunologic technique;Other: laboratory biomarker analysis;Procedure: autologous hematopoietic stem cell transplantation;Drug: Diphenhydramine;Drug: MesnaNational Cancer Institute (NCI)NULLCompleted15 Years40 YearsAll9Phase 2United States
19NCT00976300
(ClinicalTrials.gov)
January 200211/9/2009Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune StudyCyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune StudySystemic Lupus Erythematosus;Lupus NephritisDrug: Cyclosporine A;Drug: CyclophosphamideInstitute of Rheumatology, PragueMinistry of Health, Czech Republic;Charles University, Czech Republic;Palacky University;Department of Rheumatology, Hospital, Ceske Budejovice, Czech Republic;National Institute of Rheumatology, Piestany, Slovakia;Faculty Hospital St. Anna, BrnoCompleted18 Years70 YearsBoth40Phase 2Czech Republic
20NCT00017641
(ClinicalTrials.gov)
April 20016/6/2001Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: filgrastim;Procedure: CD34+ Peripheral Blood Stem Cell ReinfusionNorthwestern Memorial HospitalNULLActive, not recruitingN/A59 YearsBoth10Phase 1United States
21NCT00006055
(ClinicalTrials.gov)
March 20005/7/2000Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune DiseasesPurpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu ArteritisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell TransplantationFairview University Medical CenterNULLActive, not recruiting1 Year55 YearsBoth10N/AUnited States
22NCT00001676
(ClinicalTrials.gov)
January 19983/11/1999Cyclophosphamide and Fludarabine to Treat Lupus NephritisCombination of Cyclophosphamide and Fludarabine for Lupus Nephritis: Tolerance, Toxicity, Efficacy and Effects on B and T Lymphocyte RegenerationGlomerulonephritis;Lupus Nephritis;Systemic Lupus ErythematosusDrug: SQ FludarabineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompletedN/AN/ABoth15Phase 1United States
23NCT00010400
(ClinicalTrials.gov)
April 19972/2/2001Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody SyndromeSystemic Lupus Erythematosus;Antiphospholipid Antibody SyndromeDrug: Cyclophosphamide;Drug: filgrastimJohns Hopkins UniversityNULLCompleted18 Years70 YearsBoth35N/AUnited States
24NCT00001212
(ClinicalTrials.gov)
November 19863/11/1999Drug Therapy in Lupus NephropathyImmunosuppressive Drug Therapy in Membranous Lupus NephropathyNephrotic Syndrome;Systemic Lupus ErythematosusDrug: prednisone;Drug: cyclophosphamide;Drug: cyclosporin ANational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompletedN/AN/ABoth45Phase 2United States
25EUCTR2005-003957-28-BE
(EUCTR)
24/10/2006Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile systemic lupus erythematosus nephritis: oral cyclophosphamide versus high dose intravenous cyclophosphamide versus intermediate dose intravenous cyclophosphamide - PRINTO JSLE TrialFive year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile systemic lupus erythematosus nephritis: oral cyclophosphamide versus high dose intravenous cyclophosphamide versus intermediate dose intravenous cyclophosphamide - PRINTO JSLE Trial Systemic lupus erythematosus nephritisProduct Name: Azathioprine
INN or Proposed INN: Azathioprine
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolone sodium succinate
Product Name: Prednisolone
INN or Proposed INN: Methylprednisolone
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide
University Hospital GentNULLNAFemale: yes
Male: yes
216Phase 3Belgium;Denmark;Italy

50. 皮膚筋炎/多発性筋炎


臨床試験数 : 194 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2200059159
2022-04-262022-04-26Efficacy and safety of triple therapy based on prognostic risk stratification in patients with anti-MDA5 antibody-positive dermatomyositis: a multicenter, prospective, randomized controlled studyEfficacy and safety of triple therapy based on prognostic risk stratification in patients with anti-MDA5 antibody-positive dermatomyositis: a multicenter, prospective, randomized controlled study anti-MDA5 antibody-positive dermatomyositisexperimental group:High-dose glucocorticoid + cyclophosphamide + calcineurin inhibitor;control group:High-dose glucocorticoid + cyclophosphamide or calcineurin inhibitor;First Affiliated Hospital of Nanjing Medical UniversityNULLPending18100Bothexperimental group:60;control group:60;Phase 4China
2ChiCTR2000036709
2020-10-012020-08-24Study on early warning of rapid progressive interstitial lung disease in dermatomyositisStudy on early warning of rapid progressive interstitial lung disease in dermatomyositis DermatomyositisGroup 1:Glucocorticoid + cyclophosphamide + cyclosporin;Group 2:Glucocorticoid + cyclophosphamide + Tofacitinib;Zhongshan Hospital of Fudan UniversityNULLPending1860BothGroup 1:15;Group 2:15;N/AChina
3ChiCTR1900028143
2020-01-012019-12-13Effect of Tacrolimus on dermatomyositis/polymyositisA Single-center, randomized, controlled trial for Tacrolimus in patients with dermatomyositis/polymyositis dermatomyositis/polymyositisControl group:glucocorticoid ;Treatment group:Glucocorticoid+Tacrolimus;Control group:Glucocorticoid+Cyclophosphamide;Department of Rheumatology and Immunology, Tianjin Medical University General HospitalNULLPending1870BothControl group:20;Treatment group:20;Control group:20;Phase 4China
4EUCTR2012-003633-42-GB
(EUCTR)
18/10/201322/08/2013A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseasesA randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease
MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Cyclophosphamide Injection 1g
Product Name: Cyclophosphamide Injection 1g
INN or Proposed INN: Cyclophosphamide
Royal Brompton and Harefield NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
5JPRN-UMIN000031931
2010/12/0127/03/2018Phase 2 trial of autologous hematopoietic stem cell transplantation for severe dermatomyositisPhase 2 trial of autologous hematopoietic stem cell transplantation for severe dermatomyositis - Autologous hematopoietic stem cell transplantation for severe dermatomyositis DermatomyositisCyclophosphamide 2g/m2, 2 days
Harvest of autologous hematopoietic stem cells
Cyclophosphamide 50mg/kg, 4 days
Transplantation of autologous hematopoietic stem cells
Kyushu UniversityNULLComplete: follow-up complete16years-old65years-oldMale and Female10Phase 2Japan

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05298358
(ClinicalTrials.gov)
November 18, 20227/3/2022RIC alloBMT With Post-transplant Cyclophosphamide for Refractory Systemic SclerosisA Phase I Study of Reduced Intensity Conditioning Allogeneic Bone Marrow Transplant With Post-transplant Cyclophosphamide for Refractory Systemic SclerosisSystemic SclerosisBiological: RIC alloBMT w PTCy in refractory SScSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNULLRecruiting18 Years65 YearsAll30Phase 1United States
2NCT04380831
(ClinicalTrials.gov)
February 24, 202230/4/2020TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic SclerosisPilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic SclerosisSystemic SclerodermaProcedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Radiation: Intensity-Modulated Radiation Therapy;Procedure: Total-Body IrradiationCity of Hope Medical CenterNational Cancer Institute (NCI)Recruiting18 Years65 YearsAll15Early Phase 1United States
3JPRN-jRCTc071190041
04/01/201909/01/2020A clinical trial of autologous stem cell transplantation for severe systemic sclerosisA single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis - A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis systemic sclerosisAfter peripheral blood stem cell mobilization and aphereisi with cyclophosphamide 4 g/m2 and G-CSF, CD34+ cells were enriched by using anti-CD34 immunomagnetic beads. Conditioning was performed using high-dose cyclophosphamide (50 mg/kg) for 4 days, and freeze-thawed CD34+ cells were transplanted.Akashi KoichiNULLNot Recruiting>= 16age old< 65age oldBoth12Phase 2Japan
4NCT03630211
(ClinicalTrials.gov)
July 31, 20187/8/2018Autologous Stem Cell Transplantation in Patients With Systemic SclerosisAutologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc)Systemic Sclerosis;Diffuse Sclerosis Systemic;Interstitial Lung Disease;Pulmonary HypertensionDrug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body Irradiation;Drug: Anti Thymocyte GlobulinPaul SzabolcsNULLRecruiting8 Years60 YearsAll8Phase 2United States
5NCT03593902
(ClinicalTrials.gov)
May 17, 201828/6/2018Cardiac Safe Transplants for Systemic SclerosisAutologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac DysfunctionSystemic Sclerosis;SclerodermaDrug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem CellsNorthwestern UniversityNULLTerminated18 Years65 YearsAll9Phase 2/Phase 3United States
6NCT01862926
(ClinicalTrials.gov)
November 201422/5/2013Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILDA Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung DiseaseInterstitial Lung Disease;Scleroderma;Idiopathic Inflammatory Myositis;Mixed Connective Tissue DiseaseDrug: Rituximab;Drug: CyclophosphamideRoyal Brompton & Harefield NHS Foundation TrustImperial College London;University of East Anglia;University College London HospitalsCompleted18 Years80 YearsAll104Phase 2/Phase 3United Kingdom
7EUCTR2012-003633-42-GB
(EUCTR)
18/10/201322/08/2013A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseasesA randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease
MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Cyclophosphamide Injection 1g
Product Name: Cyclophosphamide Injection 1g
INN or Proposed INN: Cyclophosphamide
Royal Brompton and Harefield NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
8NCT01570764
(ClinicalTrials.gov)
January 14, 20132/4/2012Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung DiseaseIntravenous Cyclophosphamide for the Treatment of Systemic Sclerosis Associated Interstitial Lung DiseaseSystemic Sclerosis;Scleroderma;Interstitial Lung Disease;Lung FibrosisDrug: Cyclophosphamide;Drug: PlaceboAssistance Publique - Hôpitaux de ParisHôpital Claude-HuriezCompleted18 YearsN/AAll40Phase 3France
9NCT01445821
(ClinicalTrials.gov)
September 15, 201129/9/2011Autologous Stem Cell Systemic Sclerosis Immune Suppression TrialRandomized Study of Different Non-myeloablative Conditioning Regimens With Hematopoietic Stem Cell Support in Patients With Scleroderma (Autologous Systemic Sclerosis Immune Suppression Trial - II ASSIST-IIb)Scleroderma, SystemicBiological: Peripheral Blood Stem Cells;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: Filgrastim;Drug: FludarabineNorthwestern UniversityNULLTerminated17 Years60 YearsAll44Phase 3United States
10JPRN-UMIN000031940
2010/09/0728/03/2018Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosisPhase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosis - Autologous hematopoietic stem cell transplantation for severe systemic sclerosis Systemic sclerosisCyclophosphamide 2g/m2, 2 days
Harvest of autologous hematopoietic stem cells
Cyclophosphamide 50mg/kg, 4 days
Transplantation of autologous hematopoietic stem cells
Kyushu UniversityNULLComplete: follow-up complete16years-old65years-oldMale and Female24Phase 2Japan
11NCT02339441
(ClinicalTrials.gov)
June 201022/12/2014Treatment Outcome in Early Diffuse Cutaneous Systemic SclerosisTreatment Outcome in Early Diffuse Cutaneous Systemic SclerosisEarly Diffuse Cutaneous Systemic SclerosisDrug: Methotrexate;Drug: Mycophenolate mofetil;Drug: CyclophosphamideUniversity of ManchesterNULLCompleted18 YearsN/ABoth320N/ANULL
12NCT01047072
(ClinicalTrials.gov)
January 201011/1/2010Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic SclerosisPhase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic SclerosisSystemic SclerodermaDrug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationFred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumNational Cancer Institute (NCI)Withdrawn18 Years65 YearsBoth0Phase 2United States
13NCT00883129
(ClinicalTrials.gov)
September 200916/4/2009Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II)Scleroderma;Interstitial Lung DiseaseDrug: Mycophenolate mofetil;Drug: Cyclophosphamide;Drug: PlaceboMichael RothNational Heart, Lung, and Blood Institute (NHLBI);Hoffmann-La RocheCompleted18 YearsN/AAll142Phase 2United States
14EUCTR2006-004598-83-GB
(EUCTR)
22/10/200824/10/2008High dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy cyclophosphamide in severe systemic sclerosis ( ‘ASTIS’-TRIAL: Autologous Stem Cell Transplantation International Scleroderma Trial) - ASTISHigh dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy cyclophosphamide in severe systemic sclerosis ( ‘ASTIS’-TRIAL: Autologous Stem Cell Transplantation International Scleroderma Trial) - ASTIS Severe systemic sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Trade Name: Neupogen
Product Name: Filgrastim
INN or Proposed INN: FILGRASTIM
Trade Name: Thymoglobuline
Product Name: Thymoglobuline
Product Code: rbATG
INN or Proposed INN: Anti-Thymocyte Globulin, Rabbit
Other descriptive name: ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS
Trade Name: Solu-Medrone
Product Name: Methylprednisolone
INN or Proposed INN: METHYLPREDNISOLONE
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Trade Name: Mesna
Product Name: Mesna
INN or Proposed INN: MESNA
Trade Name: Mesna
Product Name: Mesna
INN or Proposed INN: MESNA
EBMT (European group for Blood and Marrow Transplantation)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150United Kingdom
15EUCTR2008-000224-27-GB
(EUCTR)
15/10/200807/08/2008Systemic sclerosis associated interstitial lung disease: A longitudinal observational study assessing optimum treatment regimens. - Assessment of scleroderma lung diseaseSystemic sclerosis associated interstitial lung disease: A longitudinal observational study assessing optimum treatment regimens. - Assessment of scleroderma lung disease Systemic Sclerosis associated interstitial lung disease
MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis
Trade Name: Solu-medrone
Product Name: methylprednisolone
INN or Proposed INN: METHYLPREDNISOLONE
Product Name: cyclophosphamide
Product Code: cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Newcastle upon Tyne NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
20Phase 4United Kingdom
16NCT00278525
(ClinicalTrials.gov)
September 200515/1/2006Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic SclerodermaTrial of High Dose Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG) With Hematopoietic Stem Cell Support in Patients With Systemic Scleroderma: A Randomized TrialSYSTEMIC SCLERODERMADrug: standard of care;Procedure: stem cell transplantationNorthwestern UniversityNULLCompletedN/A60 YearsAll19Phase 2United States
17NCT00114530
(ClinicalTrials.gov)
June 200515/6/2005Scleroderma: Cyclophosphamide or Transplantation (SCOT)A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01)Scleroderma, Systemic;Sclerosis;Autoimmune DiseaseBiological: mHSCT;Drug: cyclophosphamideNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years69 YearsAll75Phase 2/Phase 3United States;Canada
18NCT00860548
(ClinicalTrials.gov)
June 200511/3/2009SCOT Scleroderma Treatment Alternative Registry (STAR Registry)An Observational, Long-term Follow-up Study of Eligible Individuals Declining To Participate in the Scleroderma Cyclophosphamide or Transplantation (SCOT) Study (SCSSc-02)Scleroderma, Systemic;SclerosisDrug: currently available therapy in the communityNational Institute of Allergy and Infectious Diseases (NIAID)NULLCompleted18 Years69 YearsAll19N/AUnited States
19NCT00040651
(ClinicalTrials.gov)
July 20025/7/2002Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma PatientsTransplantation With T-Cell Depleted Autologous Peripheral Stem Cells for Severe Systemic Sclerosis: A Phase I Dose Escalation StudyScleroderma;Systemic SclerosisDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Thymoglobulin;Procedure: Leukapheresis;Procedure: Self bone marrow transplantNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)University of Pittsburgh;Amgen;Genzyme, a Sanofi CompanyTerminated18 Years70 YearsBoth15Phase 1United States
20NCT00501995
(ClinicalTrials.gov)
February 200113/7/2007High Dose Cyclophosphamide for Treatment of SclerodermaHigh Dose Cyclophosphamide for Treatment of Systemic Sclerosis (Scleroderma)SclerodermaDrug: IV CyclophosphamideJohns Hopkins UniversityNULLCompleted18 Years70 YearsAll6Phase 3United States
21NCT00016458
(ClinicalTrials.gov)
June 20006/5/2001Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic SclerosisSystemic SclerosisDrug: anti-thymocyte globulin;Drug: cyclophosphamideFred Hutchinson Cancer Research CenterNULLCompletedN/A64 YearsBoth20Phase 2United States
22NCT00004563
(ClinicalTrials.gov)
August 19999/2/2000Scleroderma Lung DiseaseCyclophosphamide Versus Placebo in Scleroderma Lung StudyLung Diseases;Pulmonary Fibrosis;Systemic Scleroderma;Scleroderma, SystemicDrug: Cyclophosphamide;Drug: PlaceboThe University of Texas Health Science Center, HoustonNational Heart, Lung, and Blood Institute (NHLBI)Completed18 YearsN/AAll158Phase 3NULL
23NCT00058578
(ClinicalTrials.gov)
June 19998/4/2003Stem Cell Transplant to Treat Patients With Systemic SclerosisAutologous T-Cell Depleted Peripheral Blood Stem Cell Transplantation for the Treatment of Selected Patients With Systemic SclerosisSystemic SclerosisDrug: Cyclophosphamide;Drug: Mesna;Drug: G-CSF;Procedure: Leukopheresis;Procedure: Total Body IrradiationBaylor College of MedicineThe Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of MedicineCompleted18 Years65 YearsAll24Phase 1United States

52. 混合性結合組織病


臨床試験数 : 8 薬物数 : 7 - (DrugBank : 3) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 1
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01862926
(ClinicalTrials.gov)
November 201422/5/2013Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILDA Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung DiseaseInterstitial Lung Disease;Scleroderma;Idiopathic Inflammatory Myositis;Mixed Connective Tissue DiseaseDrug: Rituximab;Drug: CyclophosphamideRoyal Brompton & Harefield NHS Foundation TrustImperial College London;University of East Anglia;University College London HospitalsCompleted18 Years80 YearsAll104Phase 2/Phase 3United Kingdom
2EUCTR2012-003633-42-GB
(EUCTR)
18/10/201322/08/2013A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseasesA randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease
MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Cyclophosphamide Injection 1g
Product Name: Cyclophosphamide Injection 1g
INN or Proposed INN: Cyclophosphamide
Royal Brompton and Harefield NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom

56. ベーチェット病


臨床試験数 : 81 薬物数 : 107 - (DrugBank : 30) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 116
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03371095
(ClinicalTrials.gov)
March 15, 20187/12/2017Induction Therapy With Anti-TNFa vs Cyclophosphamide in Severe Behçet DiseaseMulticenter, Randomized, Prospective Trial Comparing the Efficacy and Safety of Infliximab to That of Cyclophosphamide in Severe Behçet's Disease. ITAC : Induction Therapy With Anti-TNFa vs Cyclophosphamide in Severe Behçet DiseaseBehcet's Disease;VasculitisDrug: Infliximab;Drug: CyclophosphamideAssistance Publique - Hôpitaux de ParisNULLNot yet recruiting12 YearsN/AAll52Phase 3NULL
2EUCTR2017-002264-41-FR
(EUCTR)
19/07/2017NA Etude randomisée multicentrique évaluant l’efficacité et la tolérance de l’infliximab comparativement au Cyclophosphamide dans les formes sévères de maladie de Behçet Multicenter, randomized, prospective trial comparing the Efficacy and Safety of Infliximab to that of Cyclophosphamide in severe Behçet's disease - ITAC Induction Therapy with Anti-TNF vs Cyclophosphamide in severe Behçet disease
MedDRA version: 20.0;Level: LLT;Classification code 10004212;Term: Behcet's disease;System Organ Class: 100000017240 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Remicade 100 mg
Product Name: Remicade 100 mg
INN or Proposed INN: infliximab
Other descriptive name: infliximab
Trade Name: cyclophosphamide
Product Name: cyclophosphamide
INN or Proposed INN: cyclophosphamide
Other descriptive name: cyclophosphamide
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLNA Female: yes
Male: yes
52 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance

60. 再生不良性貧血


臨床試験数 : 245 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05600426
(ClinicalTrials.gov)
January 25, 202320/10/2022A Trial Comparing Unrelated Donor BMT With IST for Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202)A Phase III Randomized Trial Comparing Unrelated Donor Bone Marrow Transplantation With Immune Suppressive Therapy for Newly Diagnosed Pediatric and Young Adult Patients With Severe Aplastic Anemia (TransIT, BMT CTN 2202)Severe Aplastic AnemiaDrug: cyclosporine;Procedure: Matched Unrelated Donor Hematopoetic Stem Cell Transplant;Drug: horse anti-thymocyte globulin (ATG);Drug: rabbit anti-thymocyte globulin (ATG);Drug: Methotrexate;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: low-dose total body irradiation (TBI);Procedure: Immunosuppressive Therapy (IST)Boston Children's HospitalCenter for International Blood and Marrow Transplant Research;National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);North American Pediatric Aplastic Anemia Consortium;Pediatric Transplantation and Cellular Therapy Consortium;Blood and Marrow Transplant Clinical Trials NetworkRecruiting0 Years25 YearsAll234Phase 3United States
2NCT05031897
(ClinicalTrials.gov)
October 25, 202131/8/2021Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell TransplantA 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity ConditioningAcute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Aplastic Anemia;Chronic Lymphocytic Leukemia;Chronic Myelomonocytic Leukemia;Essential Thrombocythemia;Hematopoietic and Lymphoid Cell Neoplasm;Hodgkin Lymphoma;Myelodysplastic Syndromes;Myelofibrosis;Myeloid Leukemia;Myeloid Neoplasm;Non-Hodgkin Lymphoma;Plasma Cell Myeloma;Polycythemia Vera;Small Lymphocytic LymphomaProcedure: Hematopoietic Cell Transplantation;Drug: Mycophenolate Mofetil;Drug: Tacrolimus;Drug: Cyclophosphamide;Radiation: Total-Body Irradiation;Procedure: Donor Lymphocyte Infusion;Drug: Fludarabine;Drug: MelphalanThomas Jefferson UniversityNULLRecruiting18 YearsN/AAll67Phase 2United States
3ChiCTR1900026462
2019-08-192019-10-11Clinical study for umbilical cord blood mesenchymal stem cells combined with peripheral blood stem cells co-transplantation with reduced PT-Cy in the prevention of GVHD in the treatment of aplastic anemiaClinical study for umbilical cord blood mesenchymal stem cells combined with peripheral blood stem cell co-transplantation with reduced PT-Cy in the prevention of GVHD in the treatment of aplastic anemia--single-center, single-arm, open clinical study aplastic anemia,AACass series:low dose post Cyclophosphamide and Mesenchymal stem cell;Cancer Hospital Affiliated to Zhengzhou University-He'nan Cancer HospitalNULLRecruitingBothCass series:20;China
4NCT03622788
(ClinicalTrials.gov)
August 8, 20193/8/2018Cytokine-Treated Veto Cells in Treating Patients With Hematologic Malignancies Following Stem Cell TransplantAnti-Viral Central Memory CD8 Veto Cells in Haploidentical Hematopoietic Stem Cell TransplantationFollicular Lymphoma;Hodgkin Lymphoma;Mantle Cell Lymphoma;Myelodysplastic Syndrome;Myeloproliferative Neoplasm;Non-Hodgkin Lymphoma;Plasma Cell Myeloma;Acute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Aplastic Anemia;Bone Marrow Failure;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 PositiveBiological: Anti-Thymocyte Globulin;Drug: Cyclophosphamide;Biological: Cytokine-treated Veto Cells;Drug: Fludarabine;Procedure: Peripheral Blood Stem Cell Transplantation;Radiation: Total-Body IrradiationM.D. Anderson Cancer CenterNULLRecruiting12 Years75 YearsAll24Phase 1/Phase 2United States
5NCT03520647
(ClinicalTrials.gov)
February 19, 20199/5/2018Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD ProphylaxisHaplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD ProphylaxisSevere Aplastic Anemia (SAA);Hypo-Plastic Myelodysplastic Syndrome (MDS);Paroxysmal Nocturnal Hemoglobinuria (PNH)Drug: Cyclophosphamide;Other: Peripheral Blood Stem CellsNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting4 Years75 YearsAll56Phase 2United States
6NCT03579875
(ClinicalTrials.gov)
November 13, 201825/5/2018T Cell Receptor a/ß TCD HCT in Patients With Fanconi AnemiaT Cell Receptor Alpha/Beta T Cell Depleted (a/ß TCD) Hematopoietic Cell Transplantation in Patients With Fanconi Anemia (FA)Fanconi Anemia;Severe Aplastic Anemia;Myelodysplastic SyndromesDrug: Total Body Irradiation (TBI) (Plan 1);Drug: Cyclophosphamide (CY) (Plan 1);Drug: Fludarabine (FLU);Drug: Methylprednisolone (MP);Device: Donor mobilized PBSC infusion;Drug: G-CSF;Drug: Cyclophosphamide (CY) (Plan 2);Drug: Rituximab;Drug: BusulfanMasonic Cancer Center, University of MinnesotaNULLRecruitingN/A65 YearsAll48Phase 2United States
7NCT03955601
(ClinicalTrials.gov)
July 12, 201822/4/2019A Novel TBI Free Conditioning Protocol for Haploidentical Transplant in Acquired Aplastic Anemia:A Novel TBI Free Conditioning Protocol for Haploidentical Hematopoeitic Stem Cell Transplant in Acquired Aplastic AnemiaAplastic Anemia IdiopathicDrug: Haploidentical HSCT using TBI free regimen, ''ATG'' with ''Post transplant cyclophosphamide''National Institute of Blood and Marrow Transplant (NIBMT), PakistanNULLRecruiting2 Years60 YearsAll30Phase 2Pakistan
8NCT03531736
(ClinicalTrials.gov)
May 9, 20189/5/2018T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic AnemiaAllogeneic Hematopoietic Stem Cell Transplantation of a/ß T-Lymphocyte Depleted Graft Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic AnemiaMyeloid DiseasesDrug: Antithymocyte globulin (Rabbit);Drug: fludarabine;Radiation: total body irradiation;Drug: cyclophosphamide;Drug: Rituxan;Procedure: Allogeneic Hematopoietic Stem Cell TransplantationMemorial Sloan Kettering Cancer CenterNULLRecruiting18 YearsN/AAll15Phase 1United States
9NCT03333486
(ClinicalTrials.gov)
December 7, 20172/11/2017Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood CancerA Phase II Trial of Haploidentical Allogeneic Stem Cell Transplantation Utilizing Mobilized Peripheral Blood Stem CellsAccelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Acute Leukemia in Remission;Acute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Acute Myeloid Leukemia With FLT3/ITD Mutation;Acute Myeloid Leukemia With Gene Mutations;Aplastic Anemia;B-Cell Non-Hodgkin Lymphoma;CD40 Ligand Deficiency;Chronic Granulomatous Disease;Chronic Leukemia in Remission;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Congenital Amegakaryocytic Thrombocytopenia;Congenital Neutropenia;Congenital Pure Red Cell Aplasia;Glanzmann Thrombasthenia;Immunodeficiency Syndrome;Myelodysplastic Syndrome;Myelofibrosis;Myeloproliferative Neoplasm;Paroxysmal Nocturnal Hemoglobinuria;Plasma Cell Myeloma;Polycythemia Vera;Recurrent Non-Hodgkin Lymphoma;Refractory Non-Hodgkin Lymphoma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndrome;Severe Aplastic Anemia;Shwachman-Diamond Syndrome;Sickle Cell Disease;T-Cell Non-Hodgkin Lymphoma;Thalassemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich SyndromeDrug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Procedure: Peripheral Blood Stem Cell Transplantation;Radiation: Total-Body IrradiationRoswell Park Cancer InstituteNULLActive, not recruiting1 Year75 YearsAll31Phase 2United States
10ChiCTR-ONC-17012896
2017-10-012017-10-07Haploidentical Stem Cell Transplantation with Post-Transplant Cyclophosphamide Combined with Short-Term Methotrexate for Severe Aplastic AnemiaHaploidentical Stem Cell Transplantation with Post-Transplant Cyclophosphamide Combined with Short-Term Methotrexate for Severe Aplastic Anemia:a multicenter, prospective, open-label, single-arm II/III phase study Aplastic AnemiaCase series:Post-Transplant Cyclophosphamide Combined with Short-Term Methotrexate;Xiangya Hosptial of Central South UniversityNULLRecruiting265BothCase series:30;China
11NCT03192397
(ClinicalTrials.gov)
August 9, 201716/6/2017Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell TransplantA Phase Ib/2 Trial of Fludarabine/Melphalan/Total Body Irradiation With Post Transplant Cyclophosphamide as Graft Versus Host Disease Prophylaxis in Matched-Related and Matched-Unrelated Allogeneic Hematopoietic Cell TransplantationAcute Myeloid Leukemia in Remission;Adult Acute Lymphoblastic Leukemia in Complete Remission;Chronic Myelogenous Leukemia, BCR-ABL1 Positive in Remission;Chronic Myelomonocytic Leukemia in Remission;Graft Versus Host Disease;Hodgkin Lymphoma;Minimal Residual Disease;Myelodysplastic Syndrome;Myeloproliferative Neoplasm;Non-Hodgkin Lymphoma;Plasma Cell Myeloma;Severe Aplastic Anemia;Waldenstrom MacroglobulinemiaProcedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Melphalan Hydrochloride;Drug: Mycophenolate Mofetil;Drug: Sirolimus;Radiation: Total-Body IrradiationRoswell Park Cancer InstituteNULLActive, not recruiting18 YearsN/AAll35Phase 1/Phase 2United States
12NCT02918292
(ClinicalTrials.gov)
July 3, 201727/9/2016Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP) (BMT CTN 1502)Severe Aplastic AnemiaDrug: Antithymocyte Globulin (ATG);Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation (TBI);Procedure: Haplo HSCT;Drug: Tacrolimus;Drug: Mycophenolate mofetil (MMF);Drug: G-CSFMedical College of WisconsinNational Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI);Blood and Marrow Transplant Clinical Trials Network;National Marrow Donor ProgramCompletedN/A75 YearsAll32Phase 2United States
13NCT02838992
(ClinicalTrials.gov)
February 20176/7/2016ATG Combined With Cyclophosphamide And Cord Blood Transfusion in Treating Patients With Severe Aplastic AnemiaMulti-center Clinical Study of Immunosuppressants, Cyclophosphamide, And Cord Blood Transfusion in Treating Patients With Severe Aplastic AnemiaAplastic AnemiaDrug: Rabbit ATG, (Genzyme);Drug: Cy;Drug: CsA;Biological: Cord bloodJinan Military General HospitalShandong University of Traditional Chinese Medicine;Jining Medical University;Affiliated Hospital of Weifang Medical University;Guangzhou First People's Hospital;Harbin Hematology and Oncology Institute;JINING No.1 People's Hospital;JIANGXI Provincal People's Hospital;Jinhua Central Hospital;Linyi People's Hospital;Shandong Cord Blood Bank;Qingdao Center Medical Group;Qingdao University;Taian City Central Hospital;Yantai Yuhuangding Hospital;Yishui Central Hospital of LINYI;Institute of Hematology & Blood Diseases Hospital;Shengjing HospitalNot yet recruiting1 Year60 YearsAll130Phase 4China
14NCT02960646
(ClinicalTrials.gov)
January 18, 20178/11/2016Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic MalignanciesPhase I Clinical Trial Using an Engineered Peripheral Blood Graft for Haploidentical TransplantationAcute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome;Aplastic Anemia;Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Lymphoblastic Lymphoma;Myelodysplastic Syndrome;Myeloproliferative Neoplasm;Plasma Cell Myeloma;Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma;Recurrent Hodgkin Lymphoma;Recurrent Non-Hodgkin Lymphoma;Recurrent Plasma Cell Myeloma;Therapy-Related Myelodysplastic SyndromeDrug: Cyclophosphamide;Biological: Filgrastim;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Biological: Rituximab;Drug: Tacrolimus;Radiation: Total-Body IrradiationM.D. Anderson Cancer CenterNational Cancer Institute (NCI)Completed18 Years65 YearsAll11Phase 1United States
15ChiCTR1900023509
2017-01-012019-05-31Allogeneic Hematopoietic Stem Cell Transplantation with Risk-adapted Conditioning Regimens for Children with Aplastic Anemia or Refractory Cytopenia of Childhood: a Single-Center Prospective TrialAllogeneic Hematopoietic Stem Cell Transplantation with Risk-adapted Conditioning Regimens for Children with Aplastic Anemia or Refractory Cytopenia of Childhood: a Single-Center Prospective Trial aplastic anemia,Refractory Cytopenia of Childhood1:Fludarabine150 mg/m2 +Cyclophosphamide200 mg/kg+ Thymoglobuline10mg/kg;2:Fludarabine200 mg/m2 +Cyclophosphamide120 mg/kg+ Thymoglobuline10mg/kg+300cGy TBI;3:Fludarabine200 mg/m2 +Cyclophosphamide120 mg/kg+ Thymoglobuline10mg/kg+ Busulfan 8mg/kg;Shanghai Children's Medical Center affiliated to Shanghai Jiao Tong University School of MedicineNULLRecruiting18Both1:50;2:50;3:50;China
16NCT02828592
(ClinicalTrials.gov)
September 9, 20166/7/2016Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic AnemiaA Study of T-Cell Replete, HLA-Mismatched Haploidentical Bone Marrow Transplantation With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia Lacking HLA-Matched Related DonorSevere Aplastic AnemiaDrug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation;Drug: Rabbit ATGNorthside Hospital, Inc.NULLRecruiting1 Year75 YearsAll20Phase 2United States
17NCT02833805
(ClinicalTrials.gov)
September 201612/7/2016NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic AnemiaA Phase II Trial of Non-Myeloablative (NMA) Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Donor (MUD) Bone Marrow for Newly Diagnosed Patients With Severe Aplastic AnemiaSevere Aplastic Anemia;Aplastic Anemia;Bone Marrow Failure;ImmunosuppressionDrug: Thymoglobulin;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total body irradiation;Drug: Tacrolimus;Drug: Mycophenolate mofetilSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNULLCompletedN/AN/AAll21Phase 2United States
18NCT02845596
(ClinicalTrials.gov)
August 20169/5/2016Unrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic AnemiaUnrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: cyclosporine;Procedure: Matched Unrelated Donor Hematopoietic Stem Cell Transplant;Drug: horse anti-thymocyte globulin (ATG);Drug: rabbit anti-thymocyte globulin (ATG);Drug: methotrexate;Drug: fludarabine;Drug: cyclophosphamide;Radiation: low-dose total body irradiation (TBI);Procedure: Immunosuppressive Therapy (IST)Michael Pulsipher, MDNULLActive, not recruitingN/A25 YearsAll40N/AUnited States
19NCT02566304
(ClinicalTrials.gov)
November 13, 201530/9/2015Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic MalignanciesA Two Step Approach to Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic MalignanciesAcute Myeloid Leukemia;Acute Myeloid Leukemia in Remission;Aplastic Anemia;Chronic Myelomonocytic Leukemia;Hodgkin Lymphoma;Indolent Non-Hodgkin Lymphoma;Malignant Neoplasm;Myelodysplastic Syndrome;Myeloproliferative Neoplasm;Plasma Cell Myeloma;Refractory Anemia;Refractory Anemia With Excess Blasts;Refractory Anemia With Ring Sideroblasts;Refractory Cytopenia With Multilineage Dysplasia;Refractory Cytopenia With Multilineage Dysplasia and Ring SideroblastsDrug: Fludarabine;Radiation: Total-Body Irradiation;Biological: T Cell-Depleted Donor Lymphocyte Infusion;Drug: Cyclophosphamide;Procedure: Peripheral Blood Stem Cell Transplantation;Procedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Tacrolimus;Drug: Mycophenolate mofetil;Other: Laboratory Biomarker AnalysisSidney Kimmel Cancer Center at Thomas Jefferson UniversityNULLRecruiting18 YearsN/AAll35Phase 2United States
20NCT02162420
(ClinicalTrials.gov)
January 10, 201510/6/2014Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic AnemiaHematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic AnemiaDyskeratosis Congenita;Aplastic AnemiaDrug: Alemtuzumab;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation;Biological: Stem Cell Transplant;Drug: Anti-thymocyte globulinMasonic Cancer Center, University of MinnesotaNULLRecruiting0 Years70 YearsAll50N/AUnited States
21NCT02224872
(ClinicalTrials.gov)
August 201418/8/2014Transplantation of Partially Mismatched Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic AnemiaA Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia and Other Bone Marrow Failure SyndromesSevere Aplastic Anemia;Bone Marrow Failure SyndromesProcedure: Bone marrow transplant;Drug: Thymoglobulin;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: TBI;Drug: Mesna;Drug: Tacrolimus;Drug: Mycophenolic acid mofetilSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNULLCompletedN/A73 YearsAll18Phase 2United States
22NCT02065154
(ClinicalTrials.gov)
August 27, 20135/11/2013Post Transplant Cyclophosphamide (Cytoxan) for GvHD ProphylaxisPhase II Clinical Trial of the Use of Post-Transplant Cyclophosphamide for Graft Versus Host Disease (GvHD) Prophylaxis Following Matched Unrelated Donor (MUD) and Mismatched Unrelated Donor (MMUD)Hematopoietic Stem Cell Transplant (HSCT)Leukemia;Lymphoma;Myelodysplastic Syndrome;Myelofibrosis;Severe Aplastic Anemia;Allogeneic TransplantDrug: CyclophosphamideUniversity of Alabama at BirminghamNULLActive, not recruiting19 Years65 YearsAll41Phase 2United States
23NCT01760655
(ClinicalTrials.gov)
December 24, 20122/1/2013Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic MalignanciesA Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Hematologic MalignanciesAcute Myeloid Leukemia With FLT3/ITD Mutation;Acute Myeloid Leukemia With Gene Mutations;Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2); GATA2, MECOM;Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214;Aplastic Anemia;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Follicular Lymphoma;Hodgkin Lymphoma;Myelodysplastic Syndrome;Myelofibrosis;Myeloid Leukemia;Non-Hodgkin Lymphoma;Plasma Cell Myeloma;Polycythemia Vera;Recurrent Adult Acute Myeloid Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Refractory Acute Myeloid Leukemia;Secondary Acute Myeloid Leukemia;Therapy-Related Acute Myeloid LeukemiaDrug: Fludarabine phosphate;Drug: Busulfan;Radiation: Total-Body Irradiation;Biological: Therapeutic Allogeneic Lymphocytes;Drug: Cyclophosphamide;Procedure: Allogeneic Hematopoietic Stem Cell Transplantation;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Tacrolimus;Drug: Mycophenolate Mofetil;Other: Laboratory Biomarker AnalysisSidney Kimmel Cancer Center at Thomas Jefferson UniversityNational Cancer Institute (NCI)CompletedN/AN/AAll62Phase 2United States
24NCT01759732
(ClinicalTrials.gov)
September 201230/12/2012Haploidentical Stem Cell Transplantation for Children With Acquired Severe Aplastic AnemiaHaploidentical Stem Cell Transplantation With Fixed Dose of T Cells After in Vitro T Cell Depletion Using CD3 Monoclonal Antibody for Children With Acquired Severe Aplastic AnemiaAcquired Aplastic AnemiaDrug: Fludarabine;Drug: Cyclophosphamide;Biological: anti-thymocyte globulin;Biological: filgrastim;Radiation: Total body irradiation;Procedure: CD3-depleted hematopoietic cell transplantationAsan Medical CenterNULLRecruitingN/A21 YearsBoth10Phase 2Korea, Republic of
25NCT01995331
(ClinicalTrials.gov)
March 201221/11/2013Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic AnemiaModerate-dose Cyclophosphamide for Childhood Acquired Aplastic AnemiaAplastic AnemiaDrug: cyclophosphamide,cyclosporine AXiaofan ZhuNULLActive, not recruiting1 Year18 YearsBoth30Phase 4China
26NCT01384513
(ClinicalTrials.gov)
August 4, 201127/6/2011A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological MalignanciesA Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic MalignanciesAdult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Aplastic Anemia;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Myelodysplastic Syndromes;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Essential Thrombocythemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Juvenile Myelomonocytic Leukemia;Mastocytosis;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Polycythemia Vera;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Anemia;Refractory Anemia With Ringed Sideroblasts;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Myelodysplastic Syndromes;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenström Macroglobulinemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q)Drug: Fludarabine;Drug: Busulfan;Radiation: Total Body Irradiation (TBI);Biological: Donor Lymphocyte Infusion (DLI);Drug: Cyclophosphamide (CY);Drug: Tacrolimus;Drug: Mycophenolate mofetil;Device: Allogeneic hematopoietic stem cell transplantation;Procedure: Peripheral blood stem cell transplantation (PBSCT)Sidney Kimmel Cancer Center at Thomas Jefferson UniversityNULLCompleted18 YearsN/AAll40Phase 2United States
27JPRN-UMIN000006071
2011/08/0131/08/2011Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulinAllogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin - HSCT for AA using low-dose ATG SAAConditioning regimen
Fludarabine
30mg/m2/day iv day-6,-5,-4,-3
Cyclophosphamide
25mg/kg/day iv day-6,-5,-4,-3
ATG(thymoglobulin)
1.25mg/kg iv day-4,-3

In case of HSCT from unrelated donor or HLA-mismatched related donor,
TBI 2Gy day-1 will be added.
Kanto Study Group for Cell TherapyNULLComplete: follow-up complete16years-old65years-oldMale and Female28Phase 2Japan
28NCT01187017
(ClinicalTrials.gov)
August 201020/8/2010A Pilot Study of Fludarabine Plus Cyclophosphamide in Refractory Severe Aplastic AnemiaA Pilot Study of Fludarabine Plus Cyclophosphamide in Refractory Severe Aplastic AnemiaAplastic Anemia;Neutropenia;Pancytopenia;Severe Aplastic AnemiaDrug: Cyclophosphamide;Drug: FludarabineNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted2 YearsN/AAll1Phase 1/Phase 2United States
29NCT01193283
(ClinicalTrials.gov)
August 201031/8/2010Cyclophosphamide Plus Cyclosporine in Treatment-Naive Severe Aplastic AnemiaCyclophosphamide Plus Cyclosporine in Treatment-Naive Severe Aplastic AnemiaAplastic Anemia;Neutropenia;Pancytopenia;Severe Aplastic AnemiaDrug: Cyclophosphamide;Drug: CyclosporineNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted2 YearsN/AAll22Phase 1/Phase 2United States
30NCT01350245
(ClinicalTrials.gov)
July 20104/5/2011Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative DonorA Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies in Remission From HLA Partially-Matched Related DonorsAcute Myeloid Leukemia;Myelodysplastic Syndromes;Biphenotypic Leukemia;Acute Lymphocytic Leukemia;Chronic Myeloid Leukemia;Chronic Lymphocytic Leukemia;Plasma Cell Neoplasms;Lymphoma;Hodgkin's Disease;Aplastic AnemiaRadiation: Total Body Irradiation (TBI);Biological: Donor Lymphocyte Infusion (DLI);Drug: Cyclophosphamide;Drug: Mycophenolate Mofetil (MMF);Drug: Tacrolimus;Device: Hematopoietic stem cell transplantation (HSCT)Sidney Kimmel Cancer Center at Thomas Jefferson UniversityNULLCompleted18 YearsN/AAll28Phase 2United States
31NCT01145976
(ClinicalTrials.gov)
March 201019/5/2010Comparison of Cy-Atg vs Flu-Atg for the Conditioning Therapy in Allo-HCT for Adult Aplastic AnemiaRandomized Comparison of Cyclophosphamide Versus Fludarabine in Addition to Anti-thymocyte Globulin for the Conditioning Therapy in Allogeneic Hematopoietic Cell Transplantation for Adult Acquired Aplastic AnemiaAplastic AnemiaDrug: Cy-ATG;Drug: Flu-ATGCooperative Study Group A for HematologyNULLRecruiting15 Years65 YearsBoth98Phase 3Korea, Republic of
32NCT01129323
(ClinicalTrials.gov)
November 200921/4/2010Reduced-Intensity Preparative Regimen for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic AnemiaReduced-Intensity Preparative Regimen for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: Cyclophosphamide, Fludarabine, Rabbit ATGCity of Hope Medical CenterNULLWithdrawnN/A21 YearsBoth0N/AUnited States
33NCT00987480
(ClinicalTrials.gov)
September 25, 200930/9/2009Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and FludarabineA Multicenter Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and FludarabineAplastic Anemia;Leukemia;Myelodysplastic SyndromeDrug: Busulfan, fludarabine, & cyclophosphamide with immunosuppression with ATG and cyclosporine.;Device: CliniMACS deviceMemorial Sloan Kettering Cancer CenterBoston Children's Hospital;Children's Hospital Medical Center, Cincinnati;Children's Hospital and Health System Foundation, Wisconsin;Rockefeller University;Fred Hutchinson Cancer Research CenterCompletedN/AN/AAll45Phase 2United States
34NCT01105273
(ClinicalTrials.gov)
July 20098/4/2010Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Aplastic AnemiaHLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3±CD19 Depletion for Patients With Aplastic Anemia After Conditioning of Fludarabine, Cyclophosphamide and Antithymocyte GlobulinAplastic AnemiaBiological: anti-thymocyte globulin;Biological: filgrastim;Drug: Fludarabine;Drug: Cyclophosphamide;Procedure: CD3±CD19 depleted hematopoietic stem cell transplantationAsan Medical CenterNULLCompletedN/A21 YearsBoth12Phase 1/Phase 2Korea, Republic of
35NCT00882323
(ClinicalTrials.gov)
November 200815/4/2009Reduced Toxicity Fludarabine (Flu) + Cyclophosphamide (CPM) + Rabbit Antithymocyte Globulin (rATG) Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia (SAA)Reduced Toxicity Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic AnemiaAplastic AnemiaDrug: Cyclophosphamide, Fludarabine, ThymoglobulinThe Korean Society of Pediatric Hematology OncologyNULLRecruiting1 Year21 YearsBoth33Phase 2Korea, Republic of
36EUCTR2007-001657-26-GB
(EUCTR)
29/02/200807/11/2007Single Centre Phase II Pilot study of Unrelated Cord Blood Transplantation in Patients with Poor Risk Haematological Malignancies.Single Centre Phase II Pilot study of Unrelated Cord Blood Transplantation in Patients with Poor Risk Haematological Malignancies. 1.Acute, chronic leukaemia or myelodysplastic syndrome for which allogeneic transplantation is considered as the best treatment option. 2.Acute lymphoblastic leukaemia (ALL)3.Non-Hodgkin’s lymphoma4.Hodgkin’s disease5.Chronic lymphocytic leukaemia. 6.Acquired bone marrow failure syndromes7.Other haematological malignancies for which UD bone marrow transplantation is indicated
MedDRA version: 9.1;Level: LLT;Classification code 10000880;Term: Acute myeloid leukaemia
MedDRA version: 9.1;Classification code 10028533;Term: Myelodysplastic syndrome
MedDRA version: 9.1;Classification code 10009013;Term: Chronic myeloid leukaemia
MedDRA version: 9.1;Classification code 10000844;Term: Acute lymphoblastic leukaemia
MedDRA version: 9.1;Classification code 10020328;Term: Hodgkin's lymphoma
MedDRA version: 9.1;Classification code 10029593;Term: Non-Hodgkin's lymphoma NOS
MedDRA version: 9.1;Classification code 10003892;Term: B-cell chronic lymphocytic leukaemia/prolymphocytic leukaemia/small lymphocytic lymphoma
MedDRA version: 9.1;Classification code 10002968;Term: Aplastic anaemia, unspecified
Trade Name: Fludarabine
INN or Proposed INN: FLUDARABINE PHOSPHATE
Trade Name: Busilvex
INN or Proposed INN: BUSULFAN
Trade Name: Thymoglobulin
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN
Trade Name: Thiotepa
INN or Proposed INN: THIOTEPA
Trade Name: Cyclophosphamide
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Trade Name: Alkeran
INN or Proposed INN: MELPHALAN
King's College Hospital NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
27Phase 2United Kingdom
37NCT00455312
(ClinicalTrials.gov)
August 200730/3/2007Stem Cell Transplant (SCT) for Dyskeratosis Congenita or SAAHematopoietic Stem Cell Transplant For Patients With Dyskeratosis Congenita and Severe Aplastic AnemiaDyskeratosis Congenita;Aplastic AnemiaDrug: Campath 1H;Drug: Cyclophosphamide;Drug: Fludarabine;Procedure: Total Body Irradiation;Procedure: Stem Cell Transplantation;Drug: antithymocyte globulin;Drug: MethylprednisoloneMasonic Cancer Center, University of MinnesotaNULLCompletedN/A70 YearsAll36Phase 2/Phase 3United States
38NCT00578266
(ClinicalTrials.gov)
February 200717/12/2007Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic AnemiaAllogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related DonorsAnemia, AplasticDrug: Cyclophosphamide,Campath IH and TBIMayo ClinicNULLCompletedN/A60 YearsAll8Phase 1United States
39NCT00358657
(ClinicalTrials.gov)
May 24, 200628/7/2006Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant and Cyclophosphamide, Mycophenolate Mofetil, Tacrolimus, and Sirolimus in Treating Patients With Primary Immunodeficiency Disorders or Noncancerous Inherited DisordersHLA-Haploidentical Related Marrow Grafts for the Treatment of Primary Immunodeficiencies and Other Nonmalignant Disorders Using Conditioning With Low-Dose Cyclophosphamide, TBI and Fludarabine and Postgrafting CyclophosphamideImmunodeficiency Syndrome;Non-Cancer Diagnosis;Severe Aplastic Anemia;DonorProcedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Sirolimus;Drug: Tacrolimus;Radiation: Total-Body IrradiationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI);National Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingN/A55 YearsAll14Phase 2United States
40NCT00474747
(ClinicalTrials.gov)
February 7, 200616/5/2007Fludarabine-Based Conditioning for Allogeneic Marrow Transplantation in Aplastic AnemiaFludarabine-Based Conditioning for Allogeneic Marrow Transplantation From HLA-Compatible Unrelated Donors in Severe Aplastic AnemiaAplastic AnemiaDrug: Antithymocyte Globulin;Drug: Cyclophosphamide;Drug: Fludarabine;Radiation: Total Body Irradiation (TBI);Procedure: Bone Marrow TransplantM.D. Anderson Cancer CenterNational Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI)CompletedN/A65 YearsAll5Phase 1/Phase 2United States
41NCT00354419
(ClinicalTrials.gov)
February 200619/7/2006Cyclophosphamide, Antithymocyte Globulin, and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood TransplantA Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord BloodAplastic AnemiaRadiation: total-body irradiation;Drug: cyclophosphamide;Biological: anti-thymocyte globulin;Drug: cyclosporine;Procedure: umbilical cord blood transplantation;Drug: mycophenolate mofetil;Procedure: bone marrow aspiration;Genetic: DNA analysis;Biological: filgrastimFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)TerminatedN/A40 YearsBoth30Phase 1United States
42NCT00343785
(ClinicalTrials.gov)
February 200622/6/2006Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow TransplantCyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia: Effect of Marrow Cell Dose on Chronic Graft-vs.-Host Disease: A Multi-Center TrialAplastic AnemiaDrug: cyclophosphamide;Biological: anti-thymocyte globulin;Drug: cyclosporine;Procedure: allogeneic bone marrow transplantation;Drug: methotrexate;Genetic: DNA analysis;Other: flow cytometry;Genetic: polymorphism analysis;Other: laboratory biomarker analysisFred Hutchinson Cancer Research CenterNational Heart, Lung, and Blood Institute (NHLBI)CompletedN/A65 YearsAll21Phase 2United States;Canada
43NCT00326417
(ClinicalTrials.gov)
January 200612/5/2006Fludarabine-based Conditioning for Severe Aplastic Anemia (BMT CTN 0301)Fludarabine-based Conditioning for Allogeneic Marrow Transplantation From HLA-compatible Unrelated Donors in Severe Aplastic Anemia (BMT CTN #0301)Anemia, AplasticDrug: Fludarabine;Drug: Cyclophosphamide 150mg;Drug: Cyclophosphamide 100mg;Drug: Cyclophosphamide 50mgMedical College of WisconsinNational Heart, Lung, and Blood Institute (NHLBI);Blood and Marrow Transplant Clinical Trials Network;National Cancer Institute (NCI);National Marrow Donor ProgramCompletedN/A65 YearsAll97Phase 1/Phase 2United States
44NCT00737685
(ClinicalTrials.gov)
January 200618/8/2008Flu+CPM+rATG Conditioning Regimes for Unrelated Bone Marrow Transplantation (UBMT)(or Mobilized Peripheral Blood)in Severe Aplastic Anemia (SAA)Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Bone Marrow (or Mobilized Peripheral Blood) Transplantation in Severe Aplastic AnemiaAnemia, AplasticDrug: cyclophosphamide, fludarabine , thymoglobulinThe Korean Society of Pediatric Hematology OncologyNULLActive, not recruitingN/A25 YearsBoth30Phase 2Korea, Republic of
45NCT00295997
(ClinicalTrials.gov)
May 200523/2/2006Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic AnemiaNon-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic AnemiaChronic Myeloproliferative Disorders;Kidney Cancer;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative NeoplasmsBiological: anti-thymocyte globulin;Biological: filgrastim;Biological: graft-versus-tumor induction therapy;Biological: therapeutic allogeneic lymphocytes;Drug: busulfan;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methotrexate;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationUniversity of California, San FranciscoNational Cancer Institute (NCI)Active, not recruitingN/A74 YearsBoth35N/AUnited States
46NCT00533923
(ClinicalTrials.gov)
December 200220/9/2007Nonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic DisordersNonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic DisordersAML;ALL;CLL;Myelodysplastic Syndrome;Non-Hodgkin's Lymphoma;Hodgkin's Lymphoma;Multiple Myeloma;Aplastic Anemia;Myeloproliferative DisorderDrug: Cyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H (Alemtuzumab); GM-CSFBeth Israel Deaconess Medical CenterBayerCompletedN/A65 YearsBoth25Phase 2United States
47NCT00186797
(ClinicalTrials.gov)
December 20029/9/2005Purified CD34+ Hematopoietic Stem Cell Transplantation From Alternate Donors for Patients With Severe Aplastic AnemiaAplastic AnemiaProcedure: Allogeneic stem cell transplant;Drug: Fludarabine, CyclophosphamideSt. Jude Children's Research HospitalNULLCompletedN/A21 YearsBoth28N/AUnited States
48NCT00054236
(ClinicalTrials.gov)
May 20025/2/2003Combination Chemotherapy Followed By Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Severe Aplastic AnemiaPilot Study Of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning In Patients With Hematologic Disorders Or Severe Aplastic AnemiaChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative DiseasesBiological: anti-thymocyte globulin;Biological: filgrastim;Drug: cyclophosphamide;Drug: fludarabine phosphate;Procedure: umbilical cord blood transplantation;Drug: methylprednisoloneCase Comprehensive Cancer CenterNULLCompletedN/A120 YearsAll55Phase 1United States
49NCT00053989
(ClinicalTrials.gov)
January 29, 20025/2/2003NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/DisordersNon-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and DisordersChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Fanconi Anemia;Aplastic AnemiaBiological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Biological: sargramostim;Biological: therapeutic allogeneic lymphocytes;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methylprednisolone;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: peripheral blood stem cell transplantation;Procedure: umbilical cord blood transplantationRoswell Park Cancer InstituteNULLCompleted4 Years75 YearsAll41Phase 2United States
50NCT00017654
(ClinicalTrials.gov)
April 20016/6/2001Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic AnemiaGraft Versus Host Disease;Aplastic AnemiaDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: methylprednisolone;Procedure: Allogeneic Bone Marrow TransplantationNorthwestern Memorial HospitalNULLActive, not recruiting15 Years55 YearsBoth3N/AUnited States
51NCT00427336
(ClinicalTrials.gov)
December 200025/1/2007Purine Analog-Based Conditioning in Patients With Severe Aplastic AnemiaPurine Analog-Based Conditioning for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic AnemiaAplastic AnemiaDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Antithymocyte GlobulinM.D. Anderson Cancer CenterNULLCompletedN/A70 YearsAll9N/AUnited States
52NCT00006379
(ClinicalTrials.gov)
June 20004/10/2000Non-Ablative Allo HSCT For Hematologic Malignancies or SAAPurine-Analog-Containing Non-Myeloablative Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies and Severe Aplastic AnemiaChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Precancerous/Nonmalignant Condition;Small Intestine CancerBiological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Drug: cyclophosphamide;Drug: fludarabine phosphate;Procedure: peripheral blood stem cell transplantationCase Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedN/A70 YearsBoth58Phase 2United States
53NCT00636909
(ClinicalTrials.gov)
July 199910/3/2008Nonmyeloablative Allo SCT for the Treatment of Hematologic DisordersNonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic DisordersAML;ALL;CML Chronic Phase, Accelerated Phase, or Blast Crisis;CLL;MDS;RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA;APLASTIC ANEMIA;MULTIPLE MYELOMA;MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)Drug: Cyclophosphamide;Drug: fludarabine;Drug: cyclosporine;Drug: methotrexate;Biological: G-CSFBeth Israel Deaconess Medical CenterAmgenCompletedN/A65 YearsAll25Phase 2NULL
54NCT00003816
(ClinicalTrials.gov)
October 19, 19981/11/1999Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic CancerAllogeneic Blood or Marrow Transplantation for Hematologic Malignancy and Aplastic AnemiaChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Nonmalignant Neoplasm;Unspecified Adult Solid Tumor, Protocol Specific;Unspecified Childhood Solid Tumor, Protocol SpecificBiological: anti-thymocyte globulin;Drug: busulfan;Drug: carboplatin;Drug: cyclophosphamide;Drug: etoposide;Drug: fludarabine phosphate;Drug: melphalan;Drug: thiotepa;Radiation: total-body irradiationRoswell Park Cancer InstituteNULLCompleted4 Years70 YearsAll362Phase 2/Phase 3United States
55NCT00004474
(ClinicalTrials.gov)
September 199818/10/1999Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic AnemiaPhase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic AnemiaAplastic AnemiaDrug: Anti-thymocyte globulin;Drug: Cyclophosphamide;Procedure: Bone marrow transplantationRoswell Park Cancer InstituteNULLCompletedN/A59 YearsAll224Phase 3United States
56NCT00003336
(ClinicalTrials.gov)
January 19981/11/1999Pilot Study Of Unrelated UCB Transplant for Non-Malignant Hematologic ConditionsA Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With Severe Aplastic Anemia, Inborn Errors in Metabolism, or Inherited Hematologic Stem Cell DisordersLeukemia;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative DiseasesBiological: anti-thymocyte globulin;Drug: busulfan;Drug: cyclophosphamide;Drug: melphalan;Drug: methylprednisolone;Procedure: bone marrow ablation with stem cell support;Procedure: umbilical cord blood transplantation;Radiation: radiation therapyCase Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedN/A55 YearsBoth6Phase 2United States
57NCT00001626
(ClinicalTrials.gov)
June 2, 19973/11/1999Comparing Therapies for the Treatment of Severe Aplastic AnemiaA Randomized Trial of Antithymocyte Globulin and Cyclosporine Versus Cyclophosphamide and Cyclosporine in the Treatment of Severe Aplastic AnemiaSevere Aplastic Anemia (SAA)Drug: antithymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporineNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted15 Years110 YearsAll33Phase 2United States
58NCT00005852
(ClinicalTrials.gov)
June 19962/6/2000Bone Marrow Transplantation in Treating Patients With Severe Aplastic Anemia or Rejection of Previous Bone Marrow TransplantAllogeneic Bone Marrow Transplantation for Marrow Failure StatesChronic Myeloproliferative Disorders;Graft Versus Host Disease;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic SyndromesBiological: anti-thymocyte globulin;Biological: filgrastim;Biological: muromonab-CD3;Drug: cyclophosphamide;Drug: cyclosporine;Drug: methylprednisolone;Procedure: allogeneic bone marrow transplantationH. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)Terminated15 Years55 YearsBothPhase 2NULL
59NCT00004464
(ClinicalTrials.gov)
February 199618/10/1999Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal HemoglobinuriaHigh Dose Cyclophosphamide for the Treatment of Severe Aplastic Anemia and Paroxysmal Nocturnal HemoglobinuriaAplastic Anemia;Paroxysmal Hemoglobinuria, NocturnalDrug: cyclophosphamide;Drug: filgrastimSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNULLCompletedN/A70 YearsAll69Phase 2United States
60NCT00002718
(ClinicalTrials.gov)
November 19951/11/1999T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Aplastic AnemiaA Phase II Trial of T-Cell Depleted Marrow Grafts Combined With Infusions of G-CSF Stimulated, CD34 Ceprate Stem Cell Column Selected, E-Rosette Depleted Peripheral Blood Progenitor Cells Derived From HLA Haplotype Matched Related Donors for Patients With Leukemia Lacking an HLA-Matched Related or Unrelated DonorLeukemia;Lymphoma;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative NeoplasmsBiological: anti-thymocyte globulin;Biological: filgrastim;Drug: cyclophosphamide;Drug: cytarabine;Drug: methylprednisolone;Drug: thiotepa;Procedure: in vitro-treated bone marrow transplantation;Procedure: in vitro-treated peripheral blood stem cell transplantation;Radiation: radiation therapyMemorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedN/A49 YearsBoth31Phase 2United States
61NCT00004323
(ClinicalTrials.gov)
February 199518/10/1999Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic AnemiaAplastic AnemiaDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: mesna;Drug: methotrexate;Drug: methylprednisoloneNational Center for Research Resources (NCRR)University of California, Los AngelesCompletedN/A55 YearsBoth10Phase 2United States

62. 発作性夜間ヘモグロビン尿症


臨床試験数 : 292 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03520647
(ClinicalTrials.gov)
February 19, 20199/5/2018Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD ProphylaxisHaplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD ProphylaxisSevere Aplastic Anemia (SAA);Hypo-Plastic Myelodysplastic Syndrome (MDS);Paroxysmal Nocturnal Hemoglobinuria (PNH)Drug: Cyclophosphamide;Other: Peripheral Blood Stem CellsNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting4 Years75 YearsAll56Phase 2United States
2NCT03333486
(ClinicalTrials.gov)
December 7, 20172/11/2017Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood CancerA Phase II Trial of Haploidentical Allogeneic Stem Cell Transplantation Utilizing Mobilized Peripheral Blood Stem CellsAccelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Acute Leukemia in Remission;Acute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Acute Myeloid Leukemia With FLT3/ITD Mutation;Acute Myeloid Leukemia With Gene Mutations;Aplastic Anemia;B-Cell Non-Hodgkin Lymphoma;CD40 Ligand Deficiency;Chronic Granulomatous Disease;Chronic Leukemia in Remission;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Congenital Amegakaryocytic Thrombocytopenia;Congenital Neutropenia;Congenital Pure Red Cell Aplasia;Glanzmann Thrombasthenia;Immunodeficiency Syndrome;Myelodysplastic Syndrome;Myelofibrosis;Myeloproliferative Neoplasm;Paroxysmal Nocturnal Hemoglobinuria;Plasma Cell Myeloma;Polycythemia Vera;Recurrent Non-Hodgkin Lymphoma;Refractory Non-Hodgkin Lymphoma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndrome;Severe Aplastic Anemia;Shwachman-Diamond Syndrome;Sickle Cell Disease;T-Cell Non-Hodgkin Lymphoma;Thalassemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich SyndromeDrug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Procedure: Peripheral Blood Stem Cell Transplantation;Radiation: Total-Body IrradiationRoswell Park Cancer InstituteNULLActive, not recruiting1 Year75 YearsAll31Phase 2United States
3NCT00004464
(ClinicalTrials.gov)
February 199618/10/1999Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal HemoglobinuriaHigh Dose Cyclophosphamide for the Treatment of Severe Aplastic Anemia and Paroxysmal Nocturnal HemoglobinuriaAplastic Anemia;Paroxysmal Hemoglobinuria, NocturnalDrug: cyclophosphamide;Drug: filgrastimSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNULLCompletedN/A70 YearsAll69Phase 2United States

65. 原発性免疫不全症候群


臨床試験数 : 500 薬物数 : 614 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05463133
(ClinicalTrials.gov)
July 8, 202215/7/2022Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) AntagonistsPhase I/II Study Using Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) AntagonistsChronic Granulomatous DiseaseDrug: Sirolimus;Drug: Cyclophosphamide;Drug: Alemtuzumab;Drug: Busulfan;Biological: Pheripheral blood stem cells;Drug: Emapalumab-Izsg;Drug: Tociluzumab;Drug: Total Body IrradiationNational Institute of Allergy and Infectious Diseases (NIAID)NULLRecruiting4 Years65 YearsAll50Phase 1/Phase 2United States
2NCT04339777
(ClinicalTrials.gov)
September 22, 20208/4/2020Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of ImmunityA Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of ImmunityLymphoproliferative Disorders;Autoimmune Lymphoproliferative;Immune System Diseases;Common Variable Immunodeficiency;Primary T-cell Immunodeficiency DisordersDrug: Busulfan test dose;Drug: Fludarabine;Drug: Busulfan;Drug: Alemtuzumab;Radiation: Total body Irradiation;Procedure: Allogeneic HSCT;Drug: Tacrolimus (Tacro);Drug: Mycophenolate mofetil (MMF);Drug: Cyclophosphamide (Cytoxan)National Cancer Institute (NCI)NULLRecruiting4 Years69 YearsAll66Phase 2United States
3NCT03910452
(ClinicalTrials.gov)
October 28, 20199/4/2019Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant CyclophosphamideHaploidentical Transplant for Patients With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant CyclophosphamideChronic Granulomatous DiseaseDrug: Busulfan;Drug: Alemtuzumab;Drug: Cyclophosphamide;Drug: Sirolimus;Radiation: Total Body Irradiation;Biological: Allogeneic peripheral blood stem cellNational Institute of Allergy and Infectious Diseases (NIAID)NULLRecruiting4 Years65 YearsAll30Early Phase 1United States
4NCT03333486
(ClinicalTrials.gov)
December 7, 20172/11/2017Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood CancerA Phase II Trial of Haploidentical Allogeneic Stem Cell Transplantation Utilizing Mobilized Peripheral Blood Stem CellsAccelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Acute Leukemia in Remission;Acute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Acute Myeloid Leukemia With FLT3/ITD Mutation;Acute Myeloid Leukemia With Gene Mutations;Aplastic Anemia;B-Cell Non-Hodgkin Lymphoma;CD40 Ligand Deficiency;Chronic Granulomatous Disease;Chronic Leukemia in Remission;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Congenital Amegakaryocytic Thrombocytopenia;Congenital Neutropenia;Congenital Pure Red Cell Aplasia;Glanzmann Thrombasthenia;Immunodeficiency Syndrome;Myelodysplastic Syndrome;Myelofibrosis;Myeloproliferative Neoplasm;Paroxysmal Nocturnal Hemoglobinuria;Plasma Cell Myeloma;Polycythemia Vera;Recurrent Non-Hodgkin Lymphoma;Refractory Non-Hodgkin Lymphoma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndrome;Severe Aplastic Anemia;Shwachman-Diamond Syndrome;Sickle Cell Disease;T-Cell Non-Hodgkin Lymphoma;Thalassemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich SyndromeDrug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Procedure: Peripheral Blood Stem Cell Transplantation;Radiation: Total-Body IrradiationRoswell Park Cancer InstituteNULLActive, not recruiting1 Year75 YearsAll31Phase 2United States
5NCT02629120
(ClinicalTrials.gov)
December 17, 201510/12/2015High Dose Peripheral Blood Stem Cell Transplantation With Post Transplant Cyclophosphamide for Patients With Chronic Granulomatous DiseaseHigh Dose Peripheral Blood Stem Cell Transplantation With Post Transplant Cyclophosphamide for Patients With Chronic Granulomatous DiseaseChronic Granulomatous Disease TransplantDrug: Alemtuzumab;Drug: Busulfan;Drug: Sirolimus;Drug: Cyclophosphamide;Radiation: Total Body Irradiation;Biological: Peripheral blood stem cellsNational Institute of Allergy and Infectious Diseases (NIAID)NULLActive, not recruiting4 Years65 YearsAll44Phase 1/Phase 2United States
6JPRN-UMIN000019532
2015/12/0101/12/2015Clinical Phase II Study of hematopoietic stem ctell transplantation for ataxia telangiectasia and related diseasesClinical Phase II Study of hematopoietic stem ctell transplantation for ataxia telangiectasia and related diseases - HSCT for ataxia telangiectasia and related diseases ataxia telangiectasiaDNA damage response disorderfludarabine 30 mg/m2x5, cyclophosphamide 5mg/kgx4, ATG 1.25mg/kgx4Graduate Schoool,Dept. of Community Pediatrics,Perinatal and Maternal Medicine,Tokyo Medical and Dental UniversityNULLRecruitingNot applicableNot applicableMale and Female5Phase 2Japan
7NCT02162420
(ClinicalTrials.gov)
January 10, 201510/6/2014Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic AnemiaHematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic AnemiaDyskeratosis Congenita;Aplastic AnemiaDrug: Alemtuzumab;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation;Biological: Stem Cell Transplant;Drug: Anti-thymocyte globulinMasonic Cancer Center, University of MinnesotaNULLRecruiting0 Years70 YearsAll50N/AUnited States
8NCT02282904
(ClinicalTrials.gov)
October 23, 20144/11/2014Haploidentical Transplant for People With Chronic Granulomatous Disease Using Post Transplant CyclophosphamideHaploidentical Transplant for Patients With Chronic Granulomatous Disease (CGD) Using Post-Transplant CyclophosphamideChronic Granulomatous DiseaseDrug: Sirolimus;Biological: Donor peripheral blood stem cells.;Drug: Cyclophosphamide post transplant;Radiation: Total body 200cGy;Drug: Cyclophosphamide;Drug: Fludarabine;Drug: BusulfanNational Institute of Allergy and Infectious Diseases (NIAID)NULLTerminated2 Years65 YearsAll7Phase 1/Phase 2United States
9NCT01652092
(ClinicalTrials.gov)
September 4, 201225/7/2012Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune DeficienciesAllogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune DeficienciesSCID;Omenn's Syndrome;Reticular Dysgenesis;Wiskott-Aldrich Syndrome;Bare Lymphocyte Syndrome;Common Variable Immunodeficiency;Chronic Granulomatous Disease;CD40 Ligand Deficiency;Hyper IgM Syndrome;X-linked Lymphoproliferative Disease;Hemophagocytic Lymphohistiocytosis;Griscelli Syndrome;Chediak-Higashi Syndrome;Langerhan's Cell HistiocytosisDrug: Alemtuzumab 0.3 mg;Drug: Cyclophosphamide;Drug: Busulfan;Biological: Stem Cell Transplantation;Drug: Fludarabine phosphate 40 mg;Drug: Melphalan;Drug: Alemtuzumab 0.2 mg;Drug: Fludarabine phosphate 30 mg;Drug: MESNAMasonic Cancer Center, University of MinnesotaNULLRecruitingN/A50 YearsAll30N/AUnited States
10NCT00455312
(ClinicalTrials.gov)
August 200730/3/2007Stem Cell Transplant (SCT) for Dyskeratosis Congenita or SAAHematopoietic Stem Cell Transplant For Patients With Dyskeratosis Congenita and Severe Aplastic AnemiaDyskeratosis Congenita;Aplastic AnemiaDrug: Campath 1H;Drug: Cyclophosphamide;Drug: Fludarabine;Procedure: Total Body Irradiation;Procedure: Stem Cell Transplantation;Drug: antithymocyte globulin;Drug: MethylprednisoloneMasonic Cancer Center, University of MinnesotaNULLCompletedN/A70 YearsAll36Phase 2/Phase 3United States
11NCT02512679
(ClinicalTrials.gov)
February 200721/5/2015Related Hematopoietic Stem Cell Transplantation (HSCT) for Genetic Diseases of Blood CellsProtocol for Related Donor Hematopoietic Stem Cell Transplantation (HSCT) for Treatment of Symptomatic Genetic Lymphohematological DiseasesStem Cell Transplantation;Bone Marrow Transplantation;Peripheral Blood Stem Cell Transplantation;Allogeneic Transplantation;Genetic Diseases;Thalassemia;Pediatrics;Diamond-Blackfan Anemia;Combined Immune Deficiency;Wiskott-Aldrich Syndrome;Chronic Granulomatous Disease;X-linked Lymphoproliferative Disease;Metabolic DiseasesDrug: Cyclophosphamide Dose Level 1;Drug: Cyclophosphamide Dose Level 2;Drug: Cyclophosphamide Dose Level 3;Drug: Cyclophosphamide Dose Level 4Children's Hospital Los AngelesLucile Packard Children's HospitalTerminated3 MonthsN/AAll20Phase 2NULL
12NCT00358657
(ClinicalTrials.gov)
May 24, 200628/7/2006Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant and Cyclophosphamide, Mycophenolate Mofetil, Tacrolimus, and Sirolimus in Treating Patients With Primary Immunodeficiency Disorders or Noncancerous Inherited DisordersHLA-Haploidentical Related Marrow Grafts for the Treatment of Primary Immunodeficiencies and Other Nonmalignant Disorders Using Conditioning With Low-Dose Cyclophosphamide, TBI and Fludarabine and Postgrafting CyclophosphamideImmunodeficiency Syndrome;Non-Cancer Diagnosis;Severe Aplastic Anemia;DonorProcedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Sirolimus;Drug: Tacrolimus;Radiation: Total-Body IrradiationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI);National Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingN/A55 YearsAll14Phase 2United States
13NCT00578643
(ClinicalTrials.gov)
March 200419/12/2007Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous DiseaseHLA Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous DiseaseChronic Granulomatous DiseaseDrug: Busulfan;Biological: Alemtuzumab;Drug: Cyclophosphamide;Drug: Fludarabine;Drug: Cyclosporine;Procedure: Stem Cell InfusionBaylor College of MedicineNULLCompletedN/AN/AAll15Phase 2United States
14NCT00187057
(ClinicalTrials.gov)
September 200212/9/2005Study for Treatment of Cancer in Children With Ataxia-telangiectasiaPilot Study I for Treatment of Cancer in Children With Ataxia-TelangiectasiaAtaxia-TelangiectasiaDrug: vinblastine, vincristine, prednisone, daunorubicin;Drug: doxorubicin, methotrexate, cyclophosphamide, L-asparaginase;Drug: etoposide, cytarabine, mercaptopurine;Drug: dexamethasone, procarbazine;Procedure: chemotherapy, intrathecal chemotherapy, steroid therapySt. Jude Children's Research HospitalChildren's Hospital of Philadelphia;National Cancer Institute (NCI)CompletedN/A10 YearsBoth6N/AUnited States
15NCT00176852
(ClinicalTrials.gov)
June 200212/9/2005Stem Cell Transplant for HemoglobinopathyAllogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathy Using a Preparative Regimen to Achieve Stable Mixed ChimerismSickle Cell Disease;Thalassemia;Severe Congenital Neutropenia;Diamond-Blackfan Anemia;Shwachman-Diamond SyndromeDrug: Busulfan, Fludarabine, ATG, TLI;Drug: Busulfan, Cyclophosphamide, ATG, GCSF;Drug: Campath, Fludarabine, Cyclophosphamide;Radiation: Total Body Irradiation;Procedure: Stem cell infusionMasonic Cancer Center, University of MinnesotaNational Marrow Donor ProgramCompletedN/A50 YearsAll22Phase 2/Phase 3United States
16NCT01019876
(ClinicalTrials.gov)
June 200223/11/2009Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant DiseasesRisk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Selected Non-Malignant DiseasesBone Marrow Failure;Osteopetrosis;Fanconi Anemia;Severe Combined ImmunodeficiencyDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Cyclophosphamide 40;Drug: Cyclophosphamide 30Columbia UniversityNULLRecruitingN/A30 YearsBoth50Phase 2/Phase 3United States
17NCT00006054
(ClinicalTrials.gov)
March 20005/7/2000Allogeneic Bone Marrow Transplantation in Patients With Primary ImmunodeficienciesImmunologic Deficiency Syndromes;Chediak-Higashi Syndrome;Common Variable Immunodeficiency;Graft Versus Host Disease;X-Linked Lymphoproliferative Syndrome;Familial Erythrophagocytic Lymphohistiocytosis;Hemophagocytic Lymphohistiocytosis;X-linked Agammaglobulinemia;Wiskott-Aldrich Syndrome;Chronic Granulomatous Disease;X-linked Hyper IgM Syndrome;Severe Combined Immunodeficiency;Leukocyte Adhesion Deficiency Syndrome;Virus-Associated Hemophagocytic SyndromeDrug: anti-thymocyte globulin;Drug: busulfan;Drug: cyclophosphamide;Drug: cyclosporine;Drug: etoposide;Drug: methotrexate;Drug: methylprednisolone;Drug: prednisone;Procedure: Allogeneic Bone Marrow TransplantationFairview University Medical CenterNULLTerminatedN/A35 YearsBothN/AUnited States
18NCT00006056
(ClinicalTrials.gov)
March 20005/7/2000Pilot Study of Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients With Life Threatening Hemophagocytic DisordersChediak-Higashi Syndrome;Graft Versus Host Disease;X-Linked Lymphoproliferative Syndrome;Familial Erythrophagocytic Lymphohistiocytosis;Hemophagocytic Lymphohistiocytosis;Virus-Associated Hemophagocytic SyndromeDrug: anti-thymocyte globulin;Drug: busulfan;Drug: cyclophosphamide;Drug: cyclosporine;Drug: etoposide;Drug: filgrastim;Drug: methotrexate;Procedure: allogeneic hematopoietic stem cell transplantationFairview University Medical CenterNULLActive, not recruitingN/A55 YearsBoth40N/AUnited States

66. IgA腎症


臨床試験数 : 275 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03218852
(ClinicalTrials.gov)
December 20167/12/2016Extended Follow-up of Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA NephropathyAn Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA NephropathyIgA NephropathyDrug: prednisone and cyclophosphamide;Drug: prednisone aloneGuangdong General HospitalNULLActive, not recruiting18 Years70 YearsAll133Phase 4China
2NCT03015974
(ClinicalTrials.gov)
January 20163/1/2017Registry of IgA Nephropathy in Chinese ChildrenRegistry of IgA Nephropathy in Chinese ChildrenIgA Nephropathy;Proteinuria in Nephrotic Range;Immunosuppressive TreatmentDrug: Corticosteroid;Drug: Cyclophosphamide;Drug: Mycophenolate mofetil;Drug: Dipyridamole;Drug: ACE Inhibitor or Angiotensin receptor antagonistPeking University First HospitalNanjing PLA General Hospital;Beijing Children's Hospital;Central South University;The Children's Hospital of Zhejiang University School of Medicine;First Affiliated Hospital, Sun Yat-Sen University;Tongji Hospital;Hunan Children's Hospital;Shanghai Children's Hospital;Nanjing Children's Hospital;Children's Hospital of Chongqing Medical University;Shandong Provincial Hospital;Fuzhou General Hospital;Second Affiliated Hospital of Wenzhou Medical University;Children's Hospital of Hebei Province;Guangzhou Women and Children's Medical Center;Jiangxi Province Children's Hospital;Guangzhou First People's Hospital;Xian Children's Hospital;Capital Institute of Pediatrics, China;The First Hospital of Jilin University;Wuhan Women and Children's Medical Center;Tianjin Children's Hospital;Chengdu Women's and Children's Central Hospital;The First People's Hospital of YunnanRecruiting1 Month18 YearsAll1200China
3NCT01758120
(ClinicalTrials.gov)
December 201212/12/2012Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA NephropathyA Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA NephropathyIgA NephropathyDrug: prednisone plus cyclophosphamide;Drug: Prednisone aloneGuangdong General HospitalNULLActive, not recruiting18 Years70 YearsAll135Phase 4China
4EUCTR2007-000871-41-DE
(EUCTR)
24/01/200827/11/2007Supportive versus Immunosuppressive Therapy for the treatment Of Progressive IgA Nephropathy - STOP IgANSupportive versus Immunosuppressive Therapy for the treatment Of Progressive IgA Nephropathy - STOP IgAN IgA nephropathy (IgAN) as the most common type of glomerulonephritis.
MedDRA version: 16.1;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders
Product Name: Azathioprine
INN or Proposed INN: AZATHIOPRINE
Product Name: Cyclophosphamid
INN or Proposed INN: CYCLOPHOSPHAMIDE
Product Name: Prednisolon
INN or Proposed INN: PREDNISOLONE
Product Name: Methylprednisolon
INN or Proposed INN: METHYLPREDNISOLONE
Product Name: supportive therapy
RWTH AachenNULLNot RecruitingFemale: yes
Male: yes
148Germany
5NCT00301600
(ClinicalTrials.gov)
January 200310/3/2006Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA NephropathyMycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA NephropathyIGA NephropathyDrug: Mycophenolate mofetilNanjing University School of MedicineNULLCompleted12 Years65 YearsBoth40N/AChina

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00000596
(ClinicalTrials.gov)
June 197827/10/1999Diffuse Fibrotic Lung DiseaseLung Diseases;Pulmonary Fibrosis;SarcoidosisDrug: prednisone;Drug: cyclophosphamide;Drug: dapsoneNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted18 YearsN/ABothPhase 2NULL

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR1900027121
2019-10-282019-11-01The efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trialThe efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trial nonspecific interstitial pneumonia (NSIP)Group-1:Mycophenolate mofetil dispersible tablets 2 g /d; Steroid 0.75 mg/kg/d;Group-2:Tacrolimus capsule, 3mg/d, Steroid 0.75 mg/kg/d;Group-3:Cyclophosphamide 1-2mg/kg/d, Steroid 0.75 mg/kg/d;Control group:Steroid from 0.75 mg/kg/d to 15 mg/d.;Peking Union Medical College HospitalNULLRecruiting1875BothGroup-1:30;Group-2:30;Group-3:30;Control group:30;Phase 4China

93. 原発性胆汁性胆管炎


臨床試験数 : 298 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000015789
2012/11/3029/11/2015Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantationTolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation - Operational tolerance by a Treg therapy in LDLT non-compenzated liver cirrhosis(HBV,HCV, alcoholic, etc), primary biliary cirrhosis (PBC), primary screlosing cholangitis (PSC), hepatocellular carcinoma (HCC within Milan criteria), non-alcoholic steatohepatitis (NASH), othersThe patient is given cyclophosphamide (40mg/kg,iv) on postoperative days (POD) 5, and ex-vivo generated regulatory T cells on POD 13. Postoperative immunosuppression is with comventioal method. Tke immunosuppressant is reduced to 3/4 daily dose of the twice daily dose at 6 months, which is reduced to 3 times/week, 2 times/ week and 1 time/week every 3 months after confirming normal graft function and liver biopsy. the immunosuppressant is completely discontinued by 18 months after transplantation.Traslational Research and Clinical Trial CenterNULLRecruiting18years-old65years-oldMale and Female10Phase 1,2Japan

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04224558
(ClinicalTrials.gov)
December 15, 20204/4/2018Stem Cell Transplantation in Crohn's DiseaseAutologous Hematopoietic Stem Cell Transplantation for Refractory Crohn's DiseaseCrohn DiseaseDrug: Mesna;Drug: Cyclophosphamide;Drug: Filgrastim;Procedure: Apheresis catheter placement;Procedure: Leukapheresis;Drug: Fludarabine;Drug: Methylprednisolone;Drug: Diphenhydramine;Drug: Acetaminophen;Drug: anti-thymocyte globulin (rabbit);Drug: lymphocyte immune globulin;Biological: Peripheral Blood Stem Cell Infusion;Drug: CytoxanCedars-Sinai Medical CenterNULLRecruiting13 Years28 YearsAll15Phase 1/Phase 2United States
2NCT04154735
(ClinicalTrials.gov)
November 20198/3/2019Autologous Transplant Targeted Against Crohn'sAutologous Hematopoietic Stem Cell Transplant for Crohn's DiseaseCrohn's DiseaseDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: Alemtuzumab;Drug: G-CSF;Drug: Rifaximin;Drug: TacrolimusNorthwestern UniversityNULLWithdrawn18 Years49 YearsAll0Phase 2United States
3EUCTR2017-002545-30-GB
(EUCTR)
06/11/201707/06/2018Controlled trial to assess low intensity autologous stem cell transplant in refractory Crohn's DiseaseAutologous Stem cell Transplantation In refractory Crohn's disease - Low Intensity Therapy Evaluation - ASTIClite Refractory Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Cyclophosphamide
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide monohydrate
INN or Proposed INN: Cyclophosphamide monohydrate
Trade Name: Filgrastim
Product Name: Filgrastim
INN or Proposed INN: Filgrastim
Trade Name: Fludarabine
Product Name: Fludarabine
INN or Proposed INN: Fludarabine phosphate
Trade Name: Thymoglobuline
Product Name: Thymoglobuline
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
Barts Health NHS TrustNULLNot RecruitingFemale: yes
Male: yes
99Phase 3United Kingdom
4NCT03219359
(ClinicalTrials.gov)
July 12, 201713/7/2017Autologous Stem Cell Transplant for Crohn's DiseaseMaintenance in Autologous Stem Cell Transplant for Crohn's Disease (MASCT - CD)Crohn DiseaseProcedure: Autologous stem cell transplant;Drug: Cyclophosphamide;Drug: Thymoglobulin;Drug: Methylprednisolone;Drug: VedolizumabAaron EtraNULLRecruiting18 YearsN/AAll50Phase 2United States
5NCT01836289
(ClinicalTrials.gov)
March 201517/4/2013High-dose Cyclophosphamide for Severe Refractory Crohn DiseaseHigh-dose Cyclophosphamide for Severe Refractory Crohn DiseaseCrohn's Disease;Crohn DiseaseDrug: High-dose CyclophosphamideJohns Hopkins UniversityNULLWithdrawn18 Years100 YearsAll0Phase 1/Phase 2United States
6NCT01570348
(ClinicalTrials.gov)
July 17, 20122/4/2012Crohn's Allogeneic Transplant StudyAllogeneic Hematopoietic Cell Transplantation for Patients With Treatment-Refractory Crohn's Disease: A Phase 2 StudyCrohn DiseaseProcedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Drug: Mycophenolic Acid;Other: Quality-of-Life Assessment;Drug: Tacrolimus;Radiation: Total-Body IrradiationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI);National Institutes of Health (NIH)Terminated18 Years60 YearsAll2Phase 2United States
7NCT00692939
(ClinicalTrials.gov)
June 26, 20123/6/2008Autologous Stem Cell Transplantation for Crohn's DiseaseAutologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's DiseaseCrohn's DiseaseBiological: autologous CD34-selected peripheral blood stem cells transplant;Drug: Alemtuzumab;Drug: ATG;Drug: Melphalan;Drug: Thiotepa;Drug: Rituximab;Drug: Cyclophosphamide;Drug: G-CSF;Drug: MesnaPaul SzabolcsNULLRecruiting10 Years60 YearsAll20Phase 1/Phase 2United States
8EUCTR2005-003337-40-IT
(EUCTR)
19/11/200730/12/2008Autologous Stem Cell Transplantation for Crohn?s Disease: Autologous Stem Cell Transplantation International Crohn?s Disease Trial A multicentre, prospective, randomised phase III study conducted by the European Crohn?s and Colitis Organisation (ECCO), sponsored by the Autoimmune Disease Working Party of the European Group for Blood and Marrow Transplantation (EBMT) - ASTICAutologous Stem Cell Transplantation for Crohn?s Disease: Autologous Stem Cell Transplantation International Crohn?s Disease Trial A multicentre, prospective, randomised phase III study conducted by the European Crohn?s and Colitis Organisation (ECCO), sponsored by the Autoimmune Disease Working Party of the European Group for Blood and Marrow Transplantation (EBMT) - ASTIC Crohn`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns
Trade Name: ENDOXAN BAXTER
INN or Proposed INN: Cyclophosphamide
Trade Name: THYMOGLOBULINE
INN or Proposed INN: Antithymocyte immunoglobulin (rabbit)
WOLFSON DIGESTIVE DISEASES CENTRENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3United Kingdom;Italy
9EUCTR2005-003337-40-GB
(EUCTR)
13/02/200613/01/2006Autologous Stem Cell Transplantation for Crohn's Disease ('ASTIC'-Trial: Autologous Stem Cell Transplantation International Crohn's Disease Trial) - ASTICAutologous Stem Cell Transplantation for Crohn's Disease ('ASTIC'-Trial: Autologous Stem Cell Transplantation International Crohn's Disease Trial) - ASTIC Patients with Crohn's disease who have not responded to immunosupressant medicationProduct Name: Cyclophosphamide
Product Code: N/A
INN or Proposed INN: cyclophosphamide
Other descriptive name: N/A
INN or Proposed INN: cyclophosphamide
Other descriptive name: N/A
Product Name: Filgrastim
Product Code: N/A
INN or Proposed INN: Filgrastim
Other descriptive name: N/A
Product Name: rabbit antithymocyte globulin
Product Code: rbATG
INN or Proposed INN: rabbit antithymocyte globulin
Other descriptive name: N/A
Product Name: Mesna
Product Code: N/A
INN or Proposed INN: mensa
Other descriptive name: N/A
Product Name: methyl prednisolone
Product Code: N/A
INN or Proposed INN: methyl prednisolone
Other descriptive name: N/A
Product Name: ciprofloxacin
Product Code: N/A
INN or Proposed INN: ciprofloxacin
Other descriptive name: N/A
European Group for Blood and Marrow Transplantation (EMBT)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48United Kingdom

162. 類天疱瘡(後天性表皮水疱症を含む。)


臨床試験数 : 90 薬物数 : 122 - (DrugBank : 47) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 144
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03295383
(ClinicalTrials.gov)
July 11, 201922/9/2017Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane PemphigoidRandomized Double Blind Double Dummy Control Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane PemphigoidSevere Forms of Mucous Membrane PemphigoidDrug: Rituximab 1g IV;Drug: Cyclophosphamide 50Mg Oral Tablet;Drug: Placebo of Rituximab;Drug: Placebo Oral TabletUniversity Hospital, RouenNULLRecruiting18 Years80 YearsAll130Phase 3France

164. 眼皮膚白皮症


臨床試験数 : 15 薬物数 : 54 - (DrugBank : 34) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01652092
(ClinicalTrials.gov)
September 4, 201225/7/2012Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune DeficienciesAllogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune DeficienciesSCID;Omenn's Syndrome;Reticular Dysgenesis;Wiskott-Aldrich Syndrome;Bare Lymphocyte Syndrome;Common Variable Immunodeficiency;Chronic Granulomatous Disease;CD40 Ligand Deficiency;Hyper IgM Syndrome;X-linked Lymphoproliferative Disease;Hemophagocytic Lymphohistiocytosis;Griscelli Syndrome;Chediak-Higashi Syndrome;Langerhan's Cell HistiocytosisDrug: Alemtuzumab 0.3 mg;Drug: Cyclophosphamide;Drug: Busulfan;Biological: Stem Cell Transplantation;Drug: Fludarabine phosphate 40 mg;Drug: Melphalan;Drug: Alemtuzumab 0.2 mg;Drug: Fludarabine phosphate 30 mg;Drug: MESNAMasonic Cancer Center, University of MinnesotaNULLRecruitingN/A50 YearsAll30N/AUnited States
2NCT00006056
(ClinicalTrials.gov)
March 20005/7/2000Pilot Study of Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients With Life Threatening Hemophagocytic DisordersChediak-Higashi Syndrome;Graft Versus Host Disease;X-Linked Lymphoproliferative Syndrome;Familial Erythrophagocytic Lymphohistiocytosis;Hemophagocytic Lymphohistiocytosis;Virus-Associated Hemophagocytic SyndromeDrug: anti-thymocyte globulin;Drug: busulfan;Drug: cyclophosphamide;Drug: cyclosporine;Drug: etoposide;Drug: filgrastim;Drug: methotrexate;Procedure: allogeneic hematopoietic stem cell transplantationFairview University Medical CenterNULLActive, not recruitingN/A55 YearsBoth40N/AUnited States
3NCT00006054
(ClinicalTrials.gov)
March 20005/7/2000Allogeneic Bone Marrow Transplantation in Patients With Primary ImmunodeficienciesImmunologic Deficiency Syndromes;Chediak-Higashi Syndrome;Common Variable Immunodeficiency;Graft Versus Host Disease;X-Linked Lymphoproliferative Syndrome;Familial Erythrophagocytic Lymphohistiocytosis;Hemophagocytic Lymphohistiocytosis;X-linked Agammaglobulinemia;Wiskott-Aldrich Syndrome;Chronic Granulomatous Disease;X-linked Hyper IgM Syndrome;Severe Combined Immunodeficiency;Leukocyte Adhesion Deficiency Syndrome;Virus-Associated Hemophagocytic SyndromeDrug: anti-thymocyte globulin;Drug: busulfan;Drug: cyclophosphamide;Drug: cyclosporine;Drug: etoposide;Drug: methotrexate;Drug: methylprednisolone;Drug: prednisone;Procedure: Allogeneic Bone Marrow TransplantationFairview University Medical CenterNULLTerminatedN/A35 YearsBothN/AUnited States

172. 低ホスファターゼ症


臨床試験数 : 34 薬物数 : 17 - (DrugBank : 4) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 6
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000003828
2010/07/0101/07/2010Allogeneic Bone Marrow and Mesenchymal Stem Cell Transplantation for patients with severe HypophosphatasiaAllogeneic Bone Marrow and Mesenchymal Stem Cell Transplantation for patients with severe Hypophosphatasia - Allogeneic Bone Marrow and Mesenchymal Stem Cell Transplantation for patients with severe Hypophosphatasia Hypophosphatasia1. BM harvest
1)Agreement about Harvesting BM
2)Harvest volume; 100-120ml
3)Anesthetic protocol; discuss by donor
2.BMT and MSCT
First, we perform allogeneic BMT, and then allogeneic MSCT from same BM donor. Only MSCT is repeatedly performed if the patient deteriorates symptoms after BMT and MSCT.
1)BMT
-Timing of BMT
as soon as possible after diagnosis
-Conditioning
Buslfan 0.9-1mg/kg/dose every 6 hours,
4days
Cyclophosphamide 50mg/kg/dose, 4days
Antithymocyte globulin 1.25mg/kg/dose,
4days
-Prophylaxis of GVHD
Methotrexate 10-15mg/m2/dose, 4days
Taclolimus, 0.02-0.04mg/kg/day, about
6 months
2)MSCT
-Cultured-Expansion of MSCs from BM
-Preservation of MSCs
-Timing of MSCT
About 14 to 21 days After BMT
-Administration route and volume
More than 106/kg is intravenously
injected.
-Administration of immunosuppressant drugs
-Taclolimus 0.02-0.04mg/kg/day, about 6 months
3. Examination period
From July 1, 2010 to March 31, 2013
Shimane University School of MedicineNational Institute of Advanced Industrial Science and TechnologyComplete: follow-up completeNot applicable6months-oldMale and Female5Phase 2,3Japan

205. 脆弱X症候群関連疾患


臨床試験数 : 5 薬物数 : 7 - (DrugBank : 5) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 25
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00033293
(ClinicalTrials.gov)
March 15, 20049/4/2002Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With NeuroblastomaA Pilot Study Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and PrednisoneDisseminated Neuroblastoma;Localized Resectable Neuroblastoma;Localized Unresectable Neuroblastoma;Regional Neuroblastoma;Stage 4S NeuroblastomaBiological: therapeutic immune globulin;Other: clinical observation;Drug: cyclophosphamide;Drug: prednisone;Procedure: magnetic resonance imaging;Other: laboratory biomarker analysis;Drug: Corticotropin-Releasing HormoneChildren's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingN/A8 YearsAll53Phase 3United States;Australia;Canada;Netherlands;New Zealand;Puerto Rico;Switzerland

222. 一次性ネフローゼ症候群


臨床試験数 : 310 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05532111
(ClinicalTrials.gov)
September 1, 20221/9/2022Efficacy and Safety of the Treatment of Primary Membranous Nephropathy: A Randomized Clinical TrialEfficacy and Safety of Rituximab Combined With Tacrolimus in the Treatment of Intermediate-to-high Risk Primary Membranous Nephropathy: A Randomized Clinical TrialEfficacy and SafetyDrug: Rituximab combined with tacrolimus induction + rituximab maintenance;Drug: Rituximab combined with tacrolimus induction + tacrolimus maintenance;Drug: Glucocorticoid combined with cyclophosphamide induction + maintenanceRenJi HospitalNULLNot yet recruiting18 Years75 YearsAll60N/ANULL
2ChiCTR2200059658
2022-05-012022-05-05Establishment and validation of the prediction model of membranous nephropathyEstablishment and validation of the prediction model of membranous nephropathy membranous nephropathyCyclophosphamide based initial treatment:Cyclophosphamide based treatment;Cyclosporine based initial treatment:CNIs based treatment;People’s Hospital of Guangxi Zhuang Autonomous RegionNULLRecruiting1480BothCyclophosphamide based initial treatment:400;Cyclosporine based initial treatment:400;China
3ChiCTR2200057381
2022-03-012022-03-10Efficacy and safety of low-dose rituximab in the treatment of membranous nephropathyEfficacy and safety of low-dose rituximab in the treatment of membranous nephropathy membranous nephropathyrituximab group:rituximab;control:hormone combined with cyclophosphamide;Peking University Third HospitalNULLPending1880Bothrituximab group:68;control:135;N/AChina
4ChiCTR2100048518
2021-10-312021-07-09A prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathyA prospective, multi-center, real-world clinical trial of tacrolimus combined with belimumab sequential regimen and low-dose multi-target regimen in the treatment of idiopathic membranous nephropathy idiopathic membranous nephropathylow-dose multi-target group:No;tacrolimus combined with belimumab sequential group:No;intravenous cyclophosphamide pulse group:No;The Second Affiliated Hospital of Xi'an Jiaotong UniversityNULLPending1870Bothlow-dose multi-target group:100;tacrolimus combined with belimumab sequential group:100;intravenous cyclophosphamide pulse group:100;China
5ChiCTR2100050205
2021-09-012021-08-22Prediction of therapeutic effect and prognosis of different treatment schemes for idiopathic membranous nephropathy by intestinal floraPrediction of therapeutic effect and prognosis of different treatment schemes for idiopathic membranous nephropathy by intestinal flora Idiopathic membranous nephropathycontrol group:Nil;experimental group 1:Symptomatic treatment;experimental group 2:Hormone+Tacrolimus;experimental group 3:Hormone+Cyclophosphamide;experimental group 4:Hormone+Mycophenolate mofetil ester;experimental group 5:Rituximab;The First Affiliated Hospital of Shandong First Medical University&Shandong Provincial Qianfoshan HospitalNULLPending1880Bothcontrol group:30;experimental group 1:30;experimental group 2:30;experimental group 3:30;experimental group 4:30;experimental group 5:30;N/AChina
6ChiCTR2100049205
2021-08-012021-07-25A prospective randomized controlled multicenter clinical study on the treatment strategy of primary membranous nephropathy in the high-risk phaseA prospective randomized controlled multicenter clinical study on the treatment strategy of primary membranous nephropathy in the high-risk phase Membranous nephropathyGroup B:Cyclophosphamide combined with glucocorticoids;Group C:Low-dose Cyclophosphamide, glucocorticoid combined with rituximab;Group A:Rituximab;Shanghai Dongfang HospitalNULLRecruiting1875BothGroup B:30;Group C:30;Group A:30;China
7NCT04745728
(ClinicalTrials.gov)
April 14, 20214/2/2021Different Immunosuppressive Treatment in iMNDifferent Immunosuppressive Treatment in Idiopathic Membranous Nephropathy: a Prospective CohortIdiopathic Membranous NephropathyDrug: Prednisone;Drug: Cyclophosphamide;Drug: RituximabPeking Union Medical College HospitalNULLRecruiting18 Years80 YearsAll200Phase 3China
8ChiCTR2000033766
2020-07-012020-06-11Diagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimusDiagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimus Membranous nephropathy1:Prednisone + cyclophosphamide;2:Prednisone + Tacrolimus;The First Affiliated Hospital of Bengbu Medical CollegeNULLPending1770Both1:30;2:30;Phase 4China
9ChiCTR1800019833
2019-01-012018-12-02Dynamic changes of TCM syndrome types of idiopathic membranous nephropathy treated with cyclophosphamide combined with hormoneDynamic changes of TCM syndrome types of idiopathic membranous nephropathy treated with cyclophosphamide combined with hormone Idiopathic Membranous NephropathyPLA2R???:Cyclophosphamide combined with hormone therapy ;PLA2R positive Group:Cyclophosphamide combined with hormone therapy;Department of Nephrology, The First Affiliated Hospital of Zhejiang Chinese Medical UniversityNULLPending1885MalePLA2R???:30;PLA2R positive Group:30;China
10ChiCTR1800016140
2018-07-012018-05-14Comparison of the efficacy and safety of tacrolimus and glucocorticoid combined with cyclophosphamide in the treatment of adult primary membranous nephropathy: a multicenter, controlled, open studyA randomized controlled trial for the treatment of primary membranous nephropathy primary membranous nephropathyTacrolimus group:Tacrolimus 0.05-0.1mg/kg/d;Cyclophosphamide group:CTX 750mg/m2 ivgtt q2w for 8 weeks, then q4w for 4 weeks;Sichuan Provincial People's HospitalNULLPending1865BothTacrolimus group:45;Cyclophosphamide group:45;China
11NCT05679336
(ClinicalTrials.gov)
May 1, 201828/11/2022Rituximab, Cyclophosphamide, and Corticosteroids in Primary Membranous NephropathyRituximab, Cyclophosphamide, and Corticosteroids at Low Cumulative Doses to Induce Remission in Primary Membranous NephropathyMembranous Nephropathy - PLA2R InducedDrug: Rituximab, Cyclophosphamide, and CorticosteroidsSt. Petersburg State Pavlov Medical UniversityNULLRecruiting18 Years75 YearsAll40N/ARussian Federation
12NCT03466801
(ClinicalTrials.gov)
March 20, 201813/1/2018The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I.The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I.Idiopathic Membranous NephropathyDrug: Prednisone;Drug: MP and CTXWenhu LiuNULLTerminated18 Years80 YearsAll6N/AChina
13ChiCTR-IPR-17011702
2017-07-012017-06-19Compare of the treatment of membranous nephropathy with mizoribine and steroid or cyclophosphamide and steroidCompare of the treatment of membranous nephropathy with mizoribine and steroid or cyclophosphamide and steroid membranous nephropathymizoribine group:treated with mizoribine and steroid;cyclophosphamide group:treated with cyclophosphamide and steroid;Tianjin First Central HospitalNULLPending1865Bothmizoribine group:50;cyclophosphamide group:50;China
14ChiCTR-IPR-16008527
2016-06-012016-05-24Rituximab in the treatment of refractory membranous nephropathy: a multicenter, randomized, controlled clinical studyRituximab in the treatment of resistant membranous nephropathy: a multicenter, randomized, controlled clinical study Membranous nephropathyCsA group:oral CsA and glucosteroid;RTX group:intravenous RTX;CTX:Intravenous cyclophosphamide and glucosteroid;Ruijin Hospital, affiliated to Shanghai Jiaotong University, School of medicineNULLCompleted1870BothCsA group:60;RTX group:60;CTX:60;Phase 4China
15ChiCTR-IPR-16008344
2016-04-192016-04-22A study for comparing alternating glucocorticoid and cyclophosphamide versus glucocorticoid plus tacrolimus in idiopathic membranous nephropathyA study for comparing alternating glucocorticoid and cyclophosphamide versus glucocorticoid Plus tacrolimus in idiopathic membranous nephropathy idiopathic membranous nephropathyA:cyclophosphamide ;B:tacrolimus;Baoji Central HospitalNULLRecruitingBothA:30;B:30;China
16EUCTR2013-000226-55-NL
(EUCTR)
04/03/201524/06/2014SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHYEuropean Multicenter and Open-Label Controlled Randomized Trial to evaluate the Efficacy of Sequential Treatment with Tacrolimus-Rituximab versus Steroids plus Cyclophosphamide in patientes with Primary Membranous Nephropathy - STARMEN Primary membranous nephropathy
MedDRA version: 17.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Trade Name: Tacrolimus
Product Name: TACROLIMUS
INN or Proposed INN: TACROLIMUS
Other descriptive name: TACROLIMUS
Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Trade Name: Methylprednisolone
Product Name: Methylprednisolone
INN or Proposed INN: methylprednisolone
Other descriptive name: METHYLPREDNISOLONE
Trade Name: Prednisolone
Product Name: Prednisolone
INN or Proposed INN: prednisolone
Other descriptive name: PREDNISOLONE ACETATE
Trade Name: cyclophosphamide
Product Name: cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Fundacion Renal Iñigo Alvarez ToledoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
175Spain;Netherlands
17ChiCTR-IPR-14005366
2014-09-012014-01-10A prospective study of safety and efficacy in atypical membranous nephropathy by low-dose hormone combined immunosuppressive therapyA prospective study of safety and efficacy in atypical membranous nephropathy by low-dose hormone combined immunosuppressive therapy Atypical membranous nephropathyLow-dose hormone plus cyclophosphamide (CTX) grou:hormone, cyclophosphamide, three months;hormone+CsA:hormone+CsA, three months;Department of Nephrology, China-Japan Friendship HospitalNULLRecruiting1870BothLow-dose hormone plus cyclophosphamide (CTX) grou:20;hormone+CsA:20;NULL
18NCT01955187
(ClinicalTrials.gov)
January 201419/9/2013Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous NephropathyEuropean Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study)MEMBRANOUS NEPHROPATHYDrug: TACROLIMUS;Drug: RITUXIMAB;Drug: METHYLPREDNISOLONE;Drug: CYCLOPHOSPHAMIDEHospital Universitario 12 de OctubreInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz;Hospital Universitario Fundación Alcorcón;Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre;Biobanco REDinREN;ERA-EDTA;REDinREN;Sociedad Española de Nefrología;Fundación de Investigación Biomédica - Hospital Universitario de La Princesa;University Hospital, AachenCompleted18 YearsN/AAll86Phase 3Spain
19EUCTR2011-006115-59-IT
(EUCTR)
11/06/201208/06/2012A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN)A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN) - GNM-2011 MN is an autoimmune disease, suggesting that the disease may be triggered by isotype specific autoantibodies directed against podocyte enzymes and podocyte receptors that are recognized as antigens. The key role of IgG antibodies formation in the pathogenesis of IMN suggests that B cell depletion may favourably impact the evolution of the glomerular disease and reduce proteinuria. We propose this study in order to test in a randomized controlled trial the hyp
MedDRA version: 14.1;Level: PT;Classification code 10018372;Term: Glomerulonephritis membranous;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: MABTHERA*EV 1FL 50ML 500MG
Trade Name: URBASON*IM EV 1F 250MG+1F 5ML
Trade Name: MEDROL*10CPR DIV 4MG
Trade Name: ENDOXAN BAXTER*50CPR RIV 50MG
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
20NCT03018535
(ClinicalTrials.gov)
January 20129/1/2017Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous NephropathyA Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous NephropathyGlomerulonephritis, MembranousDrug: Rituximab;Drug: Methylprednisolone;Drug: CyclophosphamideAzienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity of Bari;Azienda Ospedaliera Brotzu;University of Messina;University of Milan;Universita di Verona;University of Chieti;University of Bologna;Azienda Sanitaria Locale Roma E;Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi;Regione Piemonte;University of Modena and Reggio Emilia;University of Pisa;University of Milano Bicocca;Humanitas Hospital, Italy;Azienda Ospedaliera Universitaria Policlinico;Fondazione Salvatore Maugeri;University of Bern;University of Alberta;Istituto Giannina GasliniActive, not recruiting18 YearsN/AAll76Phase 3Italy
21NCT01451489
(ClinicalTrials.gov)
October 13, 20115/8/2011The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental GlomerulosclerosisA Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental GlomerulosclerosisFSGSDrug: FK506;Drug: CyclophosphamideNanjing University School of MedicineNULLTerminated14 Years65 YearsAll70N/AChina
22ChiCTR-TRC-10001024
2008-01-012010-09-14Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosisTacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis primary focal segmental glomerulosclerosisgroup A:intravenous CTX 0.5-0.75g/m2 Monthly+Oral prednisone (Prednisolone) 0.8mg/kg.d ;group B:Oral FK506 FK506 0.1mg/kg.d+prednisone (Prednisolone) 0.5mg/kg.d ;Shanghai Jiaotong University Affiliated Ruijin HospitalNULLCompleted1875Bothgroup A:30;group B:30;China
23NCT00007475
(ClinicalTrials.gov)
December 200022/12/2000Permeability Factor in Focal Segmental GlomerulosclerosisPermeability Factor in Focal Segmental GlomerulosclerosisFocal Segmental GlomerulosclerosisProcedure: Plasma exchange;Drug: CyclophosphamideNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NULLCompletedN/AN/AAll15Phase 1/Phase 2United States
24NCT00135954
(ClinicalTrials.gov)
July 199725/8/2005Treatment of Patients With Idiopathic Membranous NephropathyTreatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive TherapyGlomerulonephritis, MembranousDrug: Cyclophosphamide and steroidsRadboud UniversityNULLCompleted18 Years75 YearsBoth29Phase 3Netherlands

224. 紫斑病性腎炎


臨床試験数 : 16 薬物数 : 43 - (DrugBank : 21) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 58
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2000039686
2020-12-012020-11-05To evaluate the efficacy and safety of tacrolimus in the treatment of children with Henoch Schonlein purpura nephritisA multicentre, randomized, prospective, observational study evaluating the efficacy and safety of tacrolimus in the treatment of Henoch Schonlein purpura nephritis in children at 24 weeks Henoch Schonlein purpura nephritisExperimental drug treatment group:Tacroximus capsule (trade name: Saifu X R), 0.1mg /kg/d, orally taken 1 hour before or 2-3 hours after meals twice a day for 24 weeks;Prednisone 1.5-2mg/kg/d was taken orally for 4 weeks and then changed to oral administration every other day for 4 weeks, gradually reducing the amount.;Control treatment group:Cyclophosphamide 8-10mg/ kg/d was given intravenously for 2 consecutive days, once every 2-4 weeks for 4 consecutive times, and once every 3 weeks for 2 consecutive times for 6 times in total.Prednisone 1.5-2mg/kg/d was taken orally with breakfast in the morning. ;Shengjing Hospital of China Medical UniversityNULLRecruitingBothExperimental drug treatment group:156;Control treatment group:78;Phase 4China
2ChiCTR2200055323
2016-08-012022-01-07Efficacy and safety of tacrolimus in the treatment of children with allergic purpura nephritisEfficacy and safety of tacrolimus in the treatment of children with allergic purpura nephritis Allergic purpuric nephritis in childrenTacrolimus group:Tacrolimus;Cyclophosphamide group:Cyclophosphamide;Mycophenolate mofetil group:Mycophenolate mofetil;Lanzhou University Second HospitalNULLCompleted418BothTacrolimus group:31;Cyclophosphamide group:31;Mycophenolate mofetil group:30;Phase 4China
3NCT02532777
(ClinicalTrials.gov)
August 201520/8/2015The Research of Standard Diagnosis and Treatment for HSPN in ChildrenThe Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in ChildrenHenoch-Schoenlein Purpura NephritisDrug: Prednisone;Drug: Cyclophosphamide(CTX);Drug: Mycophenolate mofetil(MMF);Drug: Leflunomide(LEF);Drug: Angiotensin-converting enzyme inhibitor(ACEI);Drug: MethylprednisoloneNanjing Children's HospitalNULLRecruiting2 Years16 YearsAll100Phase 2China

256. 筋型糖原病


臨床試験数 : 180 薬物数 : 133 - (DrugBank : 29) / 標的遺伝子数 : 25 - 標的パスウェイ数 : 105
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-000583-34-Outside-EU/EEA
(EUCTR)
15/04/2015Immune Tolerance Induction StudyAn Exploratory Study of the Safety and Efficacy of Immune Tolerance Induction (ITI) in Patients with Pompe Disease Who Have Previously Received Myozyme Pompe disease (acid alpha-glucosidase deficiency)
MedDRA version: 17.1;Level: LLT;Classification code 10036143;Term: Pompe's disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Alglucosidase alfa
Product Code: Myozyme®
INN or Proposed INN: ALGLUCOSIDASE ALFA
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE MONOHYDRATE
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: METHOTREXATE SODIUM
Genzyme Corporation IncNULLNAFemale: yes
Male: yes
9United States;Israel

274. 骨形成不全症


臨床試験数 : 91 薬物数 : 101 - (DrugBank : 20) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 48
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00705120
(ClinicalTrials.gov)
November 199523/6/2008Treatment of Severe Osteogenesis Imperfecta by Allogeneic Bone Marrow TransplantationTreatment of Severe (Types II and III) Osteogenesis Imperfecta by Allogeneic Bone Marrow TransplantationOsteogenesis ImperfectaOther: Bone Marrow Cell Transplantation;Radiation: Irradiation, Total Body;Drug: Cyclophosphamide;Drug: Cyclosporin;Procedure: Mesenchymal Stem Cell Transplantation;Drug: BusulfanSt. Jude Children's Research HospitalNULLCompleted3 YearsN/ABoth9Phase 1United States

283. 後天性赤芽球癆


臨床試験数 : 19 薬物数 : 36 - (DrugBank : 23) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 102
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03333486
(ClinicalTrials.gov)
December 7, 20172/11/2017Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood CancerA Phase II Trial of Haploidentical Allogeneic Stem Cell Transplantation Utilizing Mobilized Peripheral Blood Stem CellsAccelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Acute Leukemia in Remission;Acute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Acute Myeloid Leukemia With FLT3/ITD Mutation;Acute Myeloid Leukemia With Gene Mutations;Aplastic Anemia;B-Cell Non-Hodgkin Lymphoma;CD40 Ligand Deficiency;Chronic Granulomatous Disease;Chronic Leukemia in Remission;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Congenital Amegakaryocytic Thrombocytopenia;Congenital Neutropenia;Congenital Pure Red Cell Aplasia;Glanzmann Thrombasthenia;Immunodeficiency Syndrome;Myelodysplastic Syndrome;Myelofibrosis;Myeloproliferative Neoplasm;Paroxysmal Nocturnal Hemoglobinuria;Plasma Cell Myeloma;Polycythemia Vera;Recurrent Non-Hodgkin Lymphoma;Refractory Non-Hodgkin Lymphoma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndrome;Severe Aplastic Anemia;Shwachman-Diamond Syndrome;Sickle Cell Disease;T-Cell Non-Hodgkin Lymphoma;Thalassemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich SyndromeDrug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Procedure: Peripheral Blood Stem Cell Transplantation;Radiation: Total-Body IrradiationRoswell Park Cancer InstituteNULLActive, not recruiting1 Year75 YearsAll31Phase 2United States
2NCT01288131
(ClinicalTrials.gov)
January 20091/2/2011Study of Anti-r-HuEpo Associated Pure Red Cell Aplasia (PRCA) TreatmentRandomized Controlled Trial Study of Anti-r-HuEpo Associated PRCA Treated by Cyclosporine and Mycophenolate Mofetil (MMF) Compared With Cyclophosphamide and PrednisoloneAnti-r-HuEpo Associated PRCA SubjectsDrug: Cyclosporine combine with mycophenolate mofetil;Drug: Cyclophosphamide + predChulalongkorn UniversityNULLTerminated18 Years60 YearsBoth8Phase 3Thailand
3NCT00006055
(ClinicalTrials.gov)
March 20005/7/2000Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune DiseasesPurpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu ArteritisDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell TransplantationFairview University Medical CenterNULLActive, not recruiting1 Year55 YearsBoth10N/AUnited States

284. ダイアモンド・ブラックファン貧血


臨床試験数 : 36 薬物数 : 95 - (DrugBank : 34) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 126
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02512679
(ClinicalTrials.gov)
February 200721/5/2015Related Hematopoietic Stem Cell Transplantation (HSCT) for Genetic Diseases of Blood CellsProtocol for Related Donor Hematopoietic Stem Cell Transplantation (HSCT) for Treatment of Symptomatic Genetic Lymphohematological DiseasesStem Cell Transplantation;Bone Marrow Transplantation;Peripheral Blood Stem Cell Transplantation;Allogeneic Transplantation;Genetic Diseases;Thalassemia;Pediatrics;Diamond-Blackfan Anemia;Combined Immune Deficiency;Wiskott-Aldrich Syndrome;Chronic Granulomatous Disease;X-linked Lymphoproliferative Disease;Metabolic DiseasesDrug: Cyclophosphamide Dose Level 1;Drug: Cyclophosphamide Dose Level 2;Drug: Cyclophosphamide Dose Level 3;Drug: Cyclophosphamide Dose Level 4Children's Hospital Los AngelesLucile Packard Children's HospitalTerminated3 MonthsN/AAll20Phase 2NULL
2NCT00176852
(ClinicalTrials.gov)
June 200212/9/2005Stem Cell Transplant for HemoglobinopathyAllogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathy Using a Preparative Regimen to Achieve Stable Mixed ChimerismSickle Cell Disease;Thalassemia;Severe Congenital Neutropenia;Diamond-Blackfan Anemia;Shwachman-Diamond SyndromeDrug: Busulfan, Fludarabine, ATG, TLI;Drug: Busulfan, Cyclophosphamide, ATG, GCSF;Drug: Campath, Fludarabine, Cyclophosphamide;Radiation: Total Body Irradiation;Procedure: Stem cell infusionMasonic Cancer Center, University of MinnesotaNational Marrow Donor ProgramCompletedN/A50 YearsAll22Phase 2/Phase 3United States
3NCT00290628
(ClinicalTrials.gov)
October 19999/2/2006Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic CancerTransplantation of Umbilical Cord Blood From Related and Unrelated DonorsChronic Myeloproliferative Disorders;Diamond-blackfan Anemia;Fanconi Anemia;Graft Versus Host Disease;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative DiseasesDrug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: melphalan;Drug: methylprednisolone;Drug: mycophenolate mofetil;Procedure: radiation therapy;Procedure: umbilical cord blood transplantation;Drug: anti-thymocyte globulin;Drug: busulfanMasonic Cancer Center, University of MinnesotaNational Cancer Institute (NCI)TerminatedN/A45 YearsAll43N/AUnited States

285. ファンコニ貧血


臨床試験数 : 62 薬物数 : 93 - (DrugBank : 30) / 標的遺伝子数 : 30 - 標的パスウェイ数 : 144
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04784052
(ClinicalTrials.gov)
December 7, 20212/3/2021Depleted Donor Stem Cell Transplant in Children and Adults With Fanconi Anemia After Being Conditioned With a Regimen Containing JSP191 AntibodyTCRaß+ T-cell/CD19+ B-cell Depleted Hematopoietic Grafts and a Reduced Intensity Preparative Conditioning Regimen Containing JSP191 to Achieve Engraftment and Blood Reconstitution in Patients With Fanconi AnemiaFanconi AnemiaDrug: JSP191;Device: CliniMACS Prodigy System;Biological: Depleted Stem Cell Transplant;Biological: Rabbit Anti-Thymoglobulin (rATG);Drug: Cyclophosphamide;Drug: Fludarabine;Drug: RituximabRajni AgarwalNULLRecruiting2 YearsN/AAll12Phase 1/Phase 2United States
2NCT03579875
(ClinicalTrials.gov)
November 13, 201825/5/2018T Cell Receptor a/ß TCD HCT in Patients With Fanconi AnemiaT Cell Receptor Alpha/Beta T Cell Depleted (a/ß TCD) Hematopoietic Cell Transplantation in Patients With Fanconi Anemia (FA)Fanconi Anemia;Severe Aplastic Anemia;Myelodysplastic SyndromesDrug: Total Body Irradiation (TBI) (Plan 1);Drug: Cyclophosphamide (CY) (Plan 1);Drug: Fludarabine (FLU);Drug: Methylprednisolone (MP);Device: Donor mobilized PBSC infusion;Drug: G-CSF;Drug: Cyclophosphamide (CY) (Plan 2);Drug: Rituximab;Drug: BusulfanMasonic Cancer Center, University of MinnesotaNULLRecruitingN/A65 YearsAll48Phase 2United States
3NCT03600909
(ClinicalTrials.gov)
May 15, 201817/7/2018A Study of the Effect of Blood Stem Cell Transplant After Chemotherapy Alone in Patients With Fanconi AnemiaA Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Risk-Adjusted Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and FludarabineFanconi Anemia;Myelodysplastic Syndrome (MDS);Acute Myelogenous Leukemia (AML)Drug: Busulfan;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Anti-Thymocyte Globulin (Rabbit);Device: The CliniMACS device;Drug: G-CSFMemorial Sloan Kettering Cancer CenterPediatric Brain Tumor ConsortiumCompleted1 MonthN/AAll3Phase 2United States
4NCT02143830
(ClinicalTrials.gov)
April 201428/4/2014HSCT for Patients With Fanconi Anemia Using Risk-Adjusted ChemotherapyA Phase II Trial of HSCT for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Risk-Adjusted Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and FludarabineFanconi Anemia;Severe Marrow Failure;Myelodysplastic Syndrome (MDS);Acute Myelogenous Leukemia (AML)Drug: Busulfan;Drug: Cyclophosphamide;Drug: Fludarabine;Drug: rabbit ATG;Drug: G-CSF;Biological: Peripheral blood stem cellChildren's Hospital Medical Center, CincinnatiFred Hutchinson Cancer Center;Memorial Sloan Kettering Cancer CenterRecruiting3 MonthsN/AAll70Phase 2United States
5NCT02127905
(ClinicalTrials.gov)
March 201119/10/2012Unrelated HSCT in Patients With Fanconi AnemiaA Study of Total Body Irradiation, Cyclophosphamide and Fludarabine Followed by Alternated Donor Hematopoietic Cell Transplantation in Patients With Fanconi AnemiaFanconi AnemiaBiological: CD34+ selected cellsNeena Kapoor, M.D.NULLWithdrawn8 Weeks21 YearsAll0N/AUnited States
6NCT01082133
(ClinicalTrials.gov)
October 20095/3/2010Multicenter Transplant Study for Fanconi AnemiaA Multicenter Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and FludarabineFanconi AnemiaDrug: Chemotherapy;Biological: Miltenyi CliniMACSChildren's Hospital Medical Center, CincinnatiNULLCompletedN/AN/ABoth45Phase 2United States
7NCT00987480
(ClinicalTrials.gov)
September 25, 200930/9/2009Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and FludarabineA Multicenter Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and FludarabineAplastic Anemia;Leukemia;Myelodysplastic SyndromeDrug: Busulfan, fludarabine, & cyclophosphamide with immunosuppression with ATG and cyclosporine.;Device: CliniMACS deviceMemorial Sloan Kettering Cancer CenterBoston Children's Hospital;Children's Hospital Medical Center, Cincinnati;Children's Hospital and Health System Foundation, Wisconsin;Rockefeller University;Fred Hutchinson Cancer Research CenterCompletedN/AN/AAll45Phase 2United States
8NCT01071239
(ClinicalTrials.gov)
April 200920/5/2009Hematopoietic Stem Cell Transplant for Fanconi AnemiaA Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and FludarabineFanconi AnemiaDevice: CliniMACs device;Drug: Busulfan;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: ATGMedical College of WisconsinMemorial Sloan Kettering Cancer CenterCompletedN/AN/AAll1Phase 2United States
9NCT00453388
(ClinicalTrials.gov)
February 200727/3/2007Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant, Mycophenolate Mofetil, and Cyclosporine in Treating Patients With Fanconi AnemiaNonmyeloablative Hematopoietic Cell Transplantation for Patients With Fanconi Anemia Using Alternative Marrow Donors: A Phase II Dose-Finding StudyAcute Myeloid Leukemia in Remission;de Novo Myelodysplastic Syndrome;Fanconi Anemia;Previously Treated Myelodysplastic SyndromeProcedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Cyclosporine;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation;Radiation: Total-Body IrradiationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI);National Heart, Lung, and Blood Institute (NHLBI)CompletedN/AN/AAll6Phase 2United States;Brazil
10NCT00352976
(ClinicalTrials.gov)
May 18, 200614/7/2006TBI Dose De-escalation for Fanconi AnemiaTotal Body Irradiation Dose De-escalation Study in Patients With Fanconi Anemia Undergoing Alternate Donor Hematopoietic Cell TransplantationFanconi AnemiaDrug: Cyclophosphamide;Drug: Fludarabine;Procedure: Total Body Irradiation;Procedure: Bone Marrow Transplantation;Drug: Mycophenolate Mofetil;Drug: SirolimusMasonic Cancer Center, University of MinnesotaNULLCompletedN/AN/AAll88Phase 2/Phase 3United States
11NCT00084695
(ClinicalTrials.gov)
September 200310/6/2004Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant DiseasesThe Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem CellsChildhood Langerhans Cell Histiocytosis;Fanconi Anemia;Leukemia;Lymphoma;Myelodysplastic Syndromes;Neuroblastoma;Sarcoma;Unspecified Childhood Solid Tumor, Protocol SpecificBiological: anti-thymocyte globulin;Drug: busulfan;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: melphalan;Drug: methylprednisolone;Radiation: radiation therapyMilton S. Hershey Medical CenterNULLRecruitingN/A21 YearsBoth25Phase 2United States
12NCT01019876
(ClinicalTrials.gov)
June 200223/11/2009Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant DiseasesRisk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Selected Non-Malignant DiseasesBone Marrow Failure;Osteopetrosis;Fanconi Anemia;Severe Combined ImmunodeficiencyDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Cyclophosphamide 40;Drug: Cyclophosphamide 30Columbia UniversityNULLRecruitingN/A30 YearsBoth50Phase 2/Phase 3United States
13NCT00258427
(ClinicalTrials.gov)
March 26, 200222/11/2005Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi AnemiaHematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia MT2002-02Fanconi AnemiaBiological: anti-thymocyte globulin;Biological: filgrastim;Drug: busulfan;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methylprednisolone;Biological: Hematopoietic stem cell transplantationMasonic Cancer Center, University of MinnesotaNULLCompletedN/A44 YearsAll14Phase 2United States
14NCT00053989
(ClinicalTrials.gov)
January 29, 20025/2/2003NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/DisordersNon-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and DisordersChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Fanconi Anemia;Aplastic AnemiaBiological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Biological: sargramostim;Biological: therapeutic allogeneic lymphocytes;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methylprednisolone;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: peripheral blood stem cell transplantation;Procedure: umbilical cord blood transplantationRoswell Park Cancer InstituteNULLCompleted4 Years75 YearsAll41Phase 2United States
15NCT00595127
(ClinicalTrials.gov)
June 20017/1/2008Hematopoietic Stem Cell Transplantation for Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using Total Body Irradiation, Cyclophosphamide and FludarabineA Pilot Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using Total Body Irradiation, Cyclophosphamide and FludarabineFanconi AnemiaDrug: Cyclophosphamide;Drug: Fludarabine;Radiation: Total body irradiation (TBI)Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI);Miltenyi Biotec, Inc.CompletedN/AN/AAll21N/AUnited States
16NCT00630253
(ClinicalTrials.gov)
February 17, 20005/3/2008Cytoxan, Fludara, and Antithymocyte Globulin Conditioning Followed By Stem Cell Transplant in Treating Fanconi AnemiaA Study of Cyclophosphamide, Fludarabine, and Antithymocyte Globulin Followed by Matched Sibling Donor Hematopoietic Cell Transplantation in Patients With Fanconi AnemiaFanconi AnemiaBiological: Anti-Thymocyte Globulin;Drug: Cyclophosphamide;Drug: Fludarabine;Procedure: Hematopoietic Stem Cell Transplantation;Drug: Methylprednisolone;Drug: Filgrastim;Drug: Cyclosporine;Drug: Mycophenolate MofetilMasonic Cancer Center, University of MinnesotaNULLCompletedN/A59 YearsAll31Phase 1/Phase 2United States
17NCT00290628
(ClinicalTrials.gov)
October 19999/2/2006Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic CancerTransplantation of Umbilical Cord Blood From Related and Unrelated DonorsChronic Myeloproliferative Disorders;Diamond-blackfan Anemia;Fanconi Anemia;Graft Versus Host Disease;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative DiseasesDrug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: melphalan;Drug: methylprednisolone;Drug: mycophenolate mofetil;Procedure: radiation therapy;Procedure: umbilical cord blood transplantation;Drug: anti-thymocyte globulin;Drug: busulfanMasonic Cancer Center, University of MinnesotaNational Cancer Institute (NCI)TerminatedN/A45 YearsAll43N/AUnited States
18NCT00317876
(ClinicalTrials.gov)
June 199824/4/2006Cyclophosphamide in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Fanconi's AnemiaDose-Finding Study for Cyclophosphamide as Conditioning Regimens for Bone Marrow Transplantation From Related Donors in Patients With Fanconi AnemiaFanconi AnemiaDrug: cyclophosphamide;Drug: cyclosporine;Drug: methotrexate;Procedure: allogeneic bone marrow transplantation;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)CompletedN/AN/ABoth25Phase 1United States;Brazil

288. 自己免疫性後天性凝固因子欠乏症


臨床試験数 : 206 薬物数 : 231 - (DrugBank : 28) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 21
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03384277
(ClinicalTrials.gov)
October 26, 201728/11/2017Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With RituximabA Prospective, Randomized, Multicenter Clinical Trial of Acquired Haemophilia A With Steroid Combined With Cyclophosphamide Versus Steroid Combined With RituximabAcquired Hemophilia ADrug: Steroid;Drug: Rituximab;Drug: CyclophosphamideZhang Lei, MDQilu Hospital of Shandong University;Tianjin First Central Hospital;The Second Affiliated Hospital of Kunming Medical University;Henan Cancer HospitalCompleted18 Years80 YearsAll66Phase 4China
2NCT00306670
(ClinicalTrials.gov)
April 200623/3/2006Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia AA Prospective, Phase II/III Randomized, Mult-institutional Controlled, Open-label, Phase II Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Patients With Acquired Hemophilia AHemophilia ADrug: Rituxan;Drug: prednisoneGeorgetown UniversityGenentech, Inc.Terminated18 Years65 YearsAll2Phase 2/Phase 3United States

326. 大理石骨病


臨床試験数 : 18 薬物数 : 43 - (DrugBank : 14) / 標的遺伝子数 : 17 - 標的パスウェイ数 : 82
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01087398
(ClinicalTrials.gov)
September 200913/3/2010Hematopoietic Stem Cell Transplantation for Malignant Infantile OsteopetrosisHematopoietic Stem Cell Transplantation for Malignant Infantile OsteopetrosisOsteopetrosisDrug: Busulfan, Cyclophosphamide, Thymoglobulin, Fludarabine (Conditioning regimen);Procedure: Stem Cell Transplantation;Drug: Cyclosporin, Methotrexate (GVHD prophylaxis)Tehran University of Medical SciencesNULLRecruitingN/A5 YearsBoth10Phase 2/Phase 3Iran, Islamic Republic of
2NCT00775931
(ClinicalTrials.gov)
August 200816/10/2008Allogeneic Transplantation For Severe OsteopetrosisAllogeneic Hematopoietic Stem Cell Transplantation For Severe OsteopetrosisSevere OsteopetrosisProcedure: umbilical cord blood transplantation;Drug: Campath-1H;Radiation: Total Lymphoid Irradiation;Drug: Cyclophosphamide;Drug: Busulfan;Drug: Fludarabine monophosphate;Procedure: marrow graft transplantationMasonic Cancer Center, University of MinnesotaNULLCompletedN/A45 YearsAll7Phase 2/Phase 3United States
3NCT01019876
(ClinicalTrials.gov)
June 200223/11/2009Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant DiseasesRisk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Selected Non-Malignant DiseasesBone Marrow Failure;Osteopetrosis;Fanconi Anemia;Severe Combined ImmunodeficiencyDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Cyclophosphamide 40;Drug: Cyclophosphamide 30Columbia UniversityNULLRecruitingN/A30 YearsBoth50Phase 2/Phase 3United States

331. 特発性多中心性キャッスルマン病


臨床試験数 : 33 薬物数 : 41 - (DrugBank : 21) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 123
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03864419
(ClinicalTrials.gov)
October 24, 20191/3/2019Rituximab Hyaluronidase in Combination With Chemotherapy in Treating Aggressive B-cell Lymphoma in UgandaA Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With Local Standard-of-Care Chemotherapy for the Treatment of Burkitt Lymphoma, Diffuse Large B-Cell Lymphoma or as Monotherapy for Kaposi Sarcoma Herpesvirus Associated Multicentric Castleman Disease in Pediatrics and Adults in UgandaBurkitt Lymphoma;KSHV-associated Multicentric Castleman Disease;Diffuse Large B-Cell LymphomaBiological: Rituximab and Hyaluronidase Human;Drug: Cyclophosphamide;Drug: Vincristine;Drug: Methotrexate;Drug: Doxorubicin;Drug: Doxorubicin Hydrochloride;Drug: Prednisone;Drug: Etoposide;Biological: RituximabFred Hutchinson Cancer CenterNULLRecruiting2 YearsN/AAll40Phase 1Uganda;United States
2NCT03982771
(ClinicalTrials.gov)
January 1, 20193/5/2019BCD Regimen in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD)Bortezomib, Cyclophosphamide and Dexamethasone (BCD) in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD) : a Prospective, Single-center, Single-arm, Phase-II Pilot TrialIdiopathic Multicentric Castleman's DiseaseDrug: Bortezomib;Drug: Cyclophosphamide;Drug: DexamethasonPeking Union Medical College HospitalNULLRecruiting18 YearsN/AAll30Phase 2China
3NCT03043105
(ClinicalTrials.gov)
January 1, 201731/1/2017TCP Regimen in Newly Diagnosed MCD:a Prospective, Single-center, Single-arm, Phase-II Pilot TrialThalidomide, Cyclophosphamide and Prednisone in Newly Diagnosed Multicentric Castleman's Disease: a Prospective, Single-center, Single-arm, Phase-II Pilot TrialMulticentric Castleman DiseaseDrug: Thalidomide, cyclophosphamide and prednisonePeking Union Medical College HospitalNULLActive, not recruiting18 YearsN/AAll25Phase 2China
4NCT02228512
(ClinicalTrials.gov)
August 15, 201427/8/2014Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated LymphomasPhase I/II Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas (Primary Effusion Lymphoma and Large Cell Lymphoma Arising in KSHV-Associated Multicentric Castleman Disease)Large Cell Lymphoma Arising in KSHV-associated Multicentric Castleman Disease;Primary Effusion LymphomaDrug: Pomalidomide;Drug: Rituximab;Drug: Prednisone;Drug: Etoposide;Drug: Doxorubicin;Drug: Vincristine;Drug: CyclophosphamideNational Cancer Institute (NCI)NULLWithdrawn18 Years99 YearsAll0Phase 1/Phase 2United States
5NCT00092222
(ClinicalTrials.gov)
October 28, 200421/9/2004Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease ActivityTargeted Oncolytic Virotherapy and Natural History Study of KSHV-Associated Multicentric Castleman's Disease With Laboratory and Clinical Correlates of Disease ActivityLymphoproliferative Disorder;HHV-8;Malignancy;HIVDrug: Etoposide;Drug: Interferon-alpha;Drug: Rituximab;Drug: Zidovudine;Drug: Liposomal Doxorubicin;Drug: Bortezomib;Drug: Valganciclovir;Drug: Doxorubicin;Drug: Vincristine;Drug: Cyclophosphamide;Drug: Filgrastim (G-CSF);Drug: Prednisone;Drug: Sirolimus;Other: Observation OnlyNational Cancer Institute (NCI)NULLActive, not recruiting18 YearsN/AAll75Phase 2United States