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 60. 再生不良性貧血 [臨床試験数:184,薬物数:212(DrugBank:61),標的遺伝子数:33,標的パスウェイ数:34] 

Searched query = "Aplastic anemia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
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1NCT03988608December 9, 201928 October 2019Study to Assess the Safety and Efficacy of Eltrombopag in Chinese Refractory or Relapsed Severe Aplastic Anemia (SAA) Subjects.A Non-randomized, Open-label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Chinese Subjects With Refractory or Relapsed Severe Aplastic AnemiaAplastic AnemiaDrug: Eltrombopag 25 mgNovartis PharmaceuticalsNot recruiting18 YearsN/AAll20Phase 2
2JPRN-JapicCTI-19496221/10/20197 October 2019A Phase 2/3 Study of AMG531 in Patients with Aplastic AnemiaA Phase 2/3 Study of AMG531 Combined with Ciclosporin A in Patients with Aplastic Anemia Previously Untreated with Immunosuppressive TherapyAplastic AnemiaIntervention name : AMG531
INN of the intervention : romiplostim
Dosage And administration of the intervention : SC-administered
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Kyowa Kirin Co., LtdNot Recruiting20BOTH24Phase 2-3Japan, Asia except Japan
3JPRN-jRCTs07119003221/10/20195 November 2019W-JHS AA02Investigation on the effectiveness of rabbit ATG + cyclosporine + eltrombopag therapy for patients with aplastic anemia - W-JHS AA02aplastic anemia1. The administration of rATG; 2.5 mg/kg, iv. daily, day 1 - day 5 + CsA; 5 mg/kg, po. bid (before breakfast and before dinner) +adrenalcorticosteroid (the dose is mentioned after) is started. CsA used is Neoral or generic drug emulsified in the same way with Neoral. A blood level of CsA is measured and the dose which CsA blood level 2 hours after oral administration (C2) reachs 600 - 900 ng/mL is adjusted. The investigator shall reduce the dose of CsA by 25% on this occasion when blood trough level (C0) just before the administration is beyond 250 ng/mL because renal function disorder may occur (2). When serum creatinine level also becomes higher than 150% of baselines, the 25% dose reduction of CsA shall be performed. If C2 did not reach to 600 ng/mL, then dose of CsA is appropriately increased.
2. EPAG; 75 mg, po. daily (before sleep, requires to pass more than at least 2 hours after dinner) is started from day 6.
3. The dose of steroid is as follows:
Day 1 - day 5: methylprednisolone 2 mg/kg/day
Day 6: Methylprednisolone 1 mg/kg/day
Day 8, 10, 12, 14, 16, 18, 20: prednisolone 0.5 mg/kg/day
Discontinuation after day 21
4. The administration of CsA and EPAG is continued for 26 weeks. When it passed 26 weeks, further treatment mentioned above is entrusted to the investigator in each medical institution after 27 weeks if patients reached Camitta criteria CR or PR. However, the administration is continued for 52 weeks even if the dose of CsA is reduced. The treatment after 53 weeks is not specified. If patients did not reach CR or PR at 26 weeks, treatment after 27 weeks is entrusted to the investigator in each medical institution (it is not specified in this study).
Shinji NakaoRecruiting>= 18age old< 80age oldBoth60Phase 2none
4NCT03836690October 21, 20194 November 2019Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell TransplantationPhase I Study of Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell TransplantationLymphoma;Leukemia;Myeloma;Myelodysplastic Syndromes;Severe Aplastic Anemia;Primary Immune Deficiency;Graft Vs Host DiseaseBiological: CD62L- TemUniversity College, LondonMedical Research CouncilRecruiting16 Years70 YearsAll18Phase 1United Kingdom
5NCT04099966October 1, 20197 October 2019AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell DepletionAllogeneic Stem Cell Transplantation for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion - NYMC 588Acute Leukemia;Severe Aplastic Anemia;Non-hodgkin Lymphoma;Hodgkin Lymphoma;Kostmann;Diamond Blackfan Anemia;Amegakaryocytic Thrombocytopenia;Sickle Cell Disease;Beta-ThalassemiaDrug: alpha beta depletionMitchell CairoNot recruitingN/A30 YearsAll20Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
6NCT04095936October 201928 October 2019Study of AMG531 (Romiplostim) in Patients With Aplastic AnemiaA Phase 2/3 Study of AMG531 Combined With Ciclosporin A in Patients With Aplastic Anemia Previously Untreated With Immunosuppressive TherapyAplastic AnemiaDrug: RomiplostimKyowa Kirin Co., Ltd.Not recruiting20 YearsN/AAll24Phase 2/Phase 3
7ChiCTR19000264622019-08-1914 October 2019Clinical 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 studyaplastic anemia,AACass series:low dose post Cyclophosphamide and Mesenchymal stem cell;Cancer Hospital Affiliated to Zhengzhou University-He'nan Cancer HospitalRecruitingBothCass series:20;Phase 0China
8NCT03622788August 8, 201914 October 2019Cytokine-Treated Veto Cells in Treating Patients With Hematologic Malignancies Following Stem Cell TransplantAnti-Viral Central Memory CD8 Veto Cells in Haploidentical Hematopoietic Stem Cell TransplantationAcute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Aplastic Anemia;Bone Marrow Failure;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Donor;Follicular Lymphoma;Hematopoietic Cell Transplant Recipient;Hodgkin Lymphoma;Mantle Cell Lymphoma;Myelodysplastic Syndrome;Myeloproliferative Neoplasm;Non-Hodgkin Lymphoma;Plasma Cell MyelomaBiological: 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 CenterNational Cancer Institute (NCI)Recruiting12 Years70 YearsAll24Phase 1/Phase 2United States
9NCT03896971May 15, 201924 June 2019Combination of Thrombopoietin Mimetic and Immunosuppressive Therapy in Aplastic AnaemiaTreatment With Thrombopoietin Mimetic Plus Immunosuppressive Therapy in Egyptian Patients With Aplastic AnaemiaAplastic AnemiaDrug: Combination of thrombopoietin mimetic and cyclosporin ASafaa AA KhaledAssiut UniversityRecruiting16 Years65 YearsAll60Phase 4Egypt
10NCT03957694April 25, 201928 October 2019Study of AMG531(Romiplostim) in Patients With Aplastic AnemiaA Phase 2/3 Study of AMG531 in Patients With Aplastic Anemia PreviouslyUntreated With Immunosuppressive TherapyAplastic AnemiaDrug: RomiplostimKyowa Kirin Co., Ltd.Recruiting20 YearsN/AAll14Phase 2/Phase 3Japan
No.TrialIDDate_
enrollement
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11JPRN-JapicCTI-19474601/2/201916 July 2019A Phase 2/3 Study of AMG531 in Patients with Aplastic AnemiaA Phase 2/3 Study of AMG531 in Patients with Aplastic Anemia Previously Untreated with Immunosuppressive TherapyAplastic AnemiaIntervention name : AMG531
INN of the intervention : romiplostim
Dosage And administration of the intervention : SC-administered
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Kyowa Hakko Kirin Co., LtdNot Recruiting20BOTH14Phase 2-3Japan, Asia except Japan
12NCT03825744February 201925 February 2019Hetrombopag or Placebo in Treatment-Naive Severe Aplastic AnemiaA Phase III Multicenter Randomized Study of Hetrombopag or Placebo in Treatment-Naive Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: Hetrombopag Olamine+Standard Therapy;Drug: Placebo+Standard TherapyJiangsu HengRui Medicine Co., Ltd.Not recruiting15 Years75 YearsAll180Phase 3
13NCT03295058January 1, 201910 December 2018Peripheral Blood Allogenic Stem Cell Transplantation Using Non-anti Thymocyte Globulin Regimens in Severe Aplastic Anemia PatientsOutcome of Peripheral Blood Allogenic Stem Cell Transplantation Using Non-anti Thymocyte Globulin (ATG ) Conditioning Regimens in Severe Aplastic Anemia PatientsSevere Aplastic AnemiaDrug: Non ATG Conditioning regimen;Drug: GVHD Prophylaxis;Procedure: Allogenic Stem Cell Transplantation;Drug: ATG conditioning regimenAssiut UniversityNot recruiting16 Years50 YearsAll50Phase 2/Phase 3
14NCT03821987December 17, 201811 February 2019Risk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAARisk Stratification Directed Conditioning Regimen for Haploidentical HSCT in SAAAplastic Anemia;Stem Cell Transplant Complications;Engraft FailureDrug: FludarabinePeking University People's HospitalRecruiting3 Years55 YearsAll55N/AChina
15NCT03906318November 26, 201815 April 2019Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic AnemiaDrug: ItacitinibIncyte CorporationNot recruitingN/AN/AAllN/A
No.TrialIDDate_
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16EUCTR2015-003166-91-NL14/11/201830 April 2019A phase II dose escalation study: use of eltrombopag in pediatric patients with severe aplastic anemia or recurrent aplastic anemiaA phase II, open-label, non-controlled, intra-patient dose escalation study to characterize the pharmacokinetics after oral administration of eltrombopag in pediatric patients with refractory, relapsed or treatment naïve severe aplastic anemia or recurrent aplastic anemia.Refractory, relapsed or treatment naïve severe aplastic anemia (SAA) or recurrent aplastic anemia (AA)
MedDRA version: 20.0 Level: PT Classification code 10002967 Term: Aplastic anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: ETB115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: ETB115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Product Name: Eltrombopag
Product Code: ETB115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: ETB115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: ETB115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
Novartis Pharma AGAuthorised Female: yes
Male: yes
60Phase 2Portugal;United States;Hong Kong;Russian Federation;Netherlands;United Kingdom
17NCT03579875November 13, 20181 April 2019T 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: RituximabMasonic Cancer Center, University of MinnesotaRecruitingN/A65 YearsAll48Phase 2United States
18NCT03955601July 12, 201827 May 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''Armed Forces Bone Marrow Transplant Center, Rawalpindi, PakistanRecruiting2 Years60 YearsAll30Phase 2Pakistan
19NCT03557099June 30, 201825 June 2018A Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Severe Aplastic Anemia (SAA) PatientA Multicentre, Open-label, Single-arm, Phase I/II Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: Hetrombopag OlamineJiangsu HengRui Medicine Co., Ltd.Not recruiting18 YearsN/AAll55Phase 1/Phase 2China
20NCT03531736May 9, 201824 June 2019T 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 CenterRecruiting18 YearsN/AAll15Phase 1United States
No.TrialIDDate_
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21NCT03318159April 20, 201811 June 2018Posaconazole Prophylaxis During ATG Treatment for hMDS/AA PatientsOpen Label, Phase II Study Investigating the Efficacy of Posaconazole as Prophylaxis Antifungal Agent in Aplastic Anemia / Hypoplastic Myelodysplastic Syndrome Patients Undergoing Antithymocyte Globulin TreatmentAplastic Anemia;Myelodysplastic Syndromes;Fungal InfectionDrug: PosaconazoleSeoul National University HospitalMerck Sharp & Dohme Corp.Recruiting18 Years75 YearsAll40Phase 2Korea, Republic of
22NCT03218657January 1, 201816 December 2017Clinical Study of Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and LevamisoleA Prospective, Randomized, Controlled Clinical Study of Non Transfusion Dependent Non Severe Aplastic Anemia Treated With Cyclosporine, Androgen and Levamisole HydrochlorideAplastic AnemiaDrug: levamisole hydrochloride;Drug: Androgens;Drug: CyclosporinsShengyun LinRecruiting18 Years70 YearsAll248N/AChina
23JPRN-UMIN0000304532017/12/2022 July 2019Efficacy of cyclosporine therapy in the treatment of non-severe aplastic anemiaEfficacy of cyclosporine therapy in the treatment of non-severe aplastic anemia - Aplastic anemia 01 study in West Japan Hematology Study Group (W-JHS AA01 study)aplastic anemia1. Start CsA (Neoral or generic drugs emulsified in the same way as Neoral) at a dose of 3.5 mg/kg, bid (before breakfast and before dinner).
2. Measure the blood concentration of cyclosporine at 2 hours (C2) after taking the drug and determine the minimum dose of cyclosporine that produces C2 >600 ng/mL. Continue the dose of cyclosporine for 8 weeks.
3. Continue the treatment for further 44 weeks (a total of 52 weeks) when patients meet the response criteria of HI-E or HI-P at the end of the 8 week treatment. Treatments after the 52 weeks are not specified. When patients do not meet the IWG response criteria 2006 at the end of 8 weeks, the treatment is terminated and treatments after 9 weeks are not specified.
Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center KyushuRecruiting16years-oldNot applicableMale and Female33Not selectedJapan
24NCT03333486December 7, 201725 June 2018Fludarabine 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 InstituteNational Cancer Institute (NCI)Recruiting1 Year75 YearsAll58Phase 2United States
25NCT03243656December 201716 December 2017Eltrombopag in Children With Idiopathic Aplastic AnemiaRandomized Clinical Trial of the Use of Eltrombopag in Children With Idiopathic Aplastic AnemiaEltrombopagDrug: EltrombopagAssiut UniversityNot recruiting1 Year18 YearsAll20Phase 4
No.TrialIDDate_
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26NCT03176849November 1, 201718 December 2018A Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 in Pediatric Patients Undergoing HSCTA Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 (Stoss Therapy) in Pediatric Patients Undergoing HSCT to Prevent Vitamin D Deficiency and Insufficiency During TransplantVitamin D Deficiency;Stem Cell Transplant Complications;Pediatric Cancer;Blood Disorder;Pediatric Acute Myeloid Leukemia;Pediatric Acute Lymphoid Leukemia;Myelodysplastic Syndromes;Sickle Cell Anemia in Children;Aplastic Anemia;Thalassemia in ChildrenDietary Supplement: Vitamin D3;Dietary Supplement: Standard Vitamin D3 SupplementationPhoenix Children's HospitalRecruiting1 Year25 YearsAll50Phase 4United States
27ChiCTR-ONC-170128962017-10-019 October 2017Haploidentical 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 studyAplastic AnemiaCase series:Post-Transplant Cyclophosphamide Combined with Short-Term Methotrexate;Xiangya Hosptial of Central South UniversityRecruiting265BothCase series:30;New Treatment Measure Clinical StudyChina
28NCT03192397August 3, 201729 April 2019Chemotherapy, 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 II 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 InstituteNational Cancer Institute (NCI)Recruiting18 Years79 YearsAll30Phase 2United States
29NCT02918292July 3, 201718 December 2018Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP) (BMT CTN #1502)Severe Aplastic AnemiaDrug: Cyclophosphamide;Radiation: Total Body Irradiation (TBI);Procedure: Haplo HSCT;Drug: Tacrolimus;Drug: Mycophenolate mofetil (MMF);Drug: G-CSF;Drug: Fludarabine;Drug: Antithymocyte Globulin (ATG)Medical College of WisconsinNational Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI);Blood and Marrow Transplant Clinical Trials Network;National Marrow Donor ProgramRecruitingN/A75 YearsAll30Phase 2United States
30ChiCTR-IOR-170116532017-07-0119 June 2017A prospective, randomized, controlled clinical study of non transfusion dependent non severe aplastic anemia treated with cyclosporine, androgen and levamisole hydrochlorideA prospective, randomized, controlled clinical study of non transfusion dependent non severe aplastic anemia treated with cyclosporine, androgen and levamisole hydrochlorideAplastic anemiaSA group:none;LSA group:levamisole hydrochloride;The First affiliated Hospital of Zhejiang Chinese Medical UniversityNot Recruiting1870BothSA group:124;LSA group:124;OtherChina
No.TrialIDDate_
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31NCT03173937June 13, 201714 October 2019Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant OutcomeUnrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant OutcomeSevere Aplastic Anemia;Hypo-Plastic MDS;Myelodysplastic Syndrome (MDS)Biological: CordInNational Heart, Lung, and Blood Institute (NHLBI)Recruiting4 Years75 YearsAll68Phase 1/Phase 2United States
32NCT02998645May 11, 201725 February 2019Eltrombopag Combined With Cyclosporine as First Line Therapy in Patients With Severe Acquired Aplastic AnemiaSOAR Trial, A Two-part Study: Interventional Phase II Single-arm Trial to Assess Efficacy and Safety of Eltrombopag Combined With Cyclosporine as First Line Therapy in Patients With Severe Acquired Aplastic Anemia, and an Extension With up to 60-months Follow-upSevere Aplastic AnemiaDrug: eltrombopag;Drug: CyclosporineNovartis PharmaceuticalsRecruiting6 YearsN/AAll50Phase 2Brazil;Hong Kong;Hungary;India;Italy;Korea, Republic of;Netherlands;Spain;Thailand;Turkey
33NCT03025698May 11, 20174 November 2019A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic AnemiaA Phase II, Open-label, Non-controlled, Intra-patient Dose-escalation Study to Characterize the Pharmacokinetics After Oral Administration of Eltrombopag in Pediatric Patients With Refractory, Relapsed or Treatment Naive Severe Aplastic Anemia or Recurrent Aplastic AnemiaAplastic AnemiaDrug: Eltrombopag;Drug: hATG;Drug: CsANovartis PharmaceuticalsRecruiting1 Year18 YearsAll60Phase 2United States;Hong Kong;Netherlands;Portugal;Russian Federation;Thailand;United Kingdom
34EUCTR2016-002814-29-ES21/03/201728 February 2019SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia with follow-up up to 60-months.SOAR Trial, A two-part study: Interventional phase II single-arm trial to assess efficacy and safety of Eltrombopag combined with cyclosporine as first line therapy in patients with severe acquired aplastic anemia, and an extension with up to 60-months follow-up. - SOARFirst-line severe aplastic anaemia
MedDRA version: 19.0 Level: PT Classification code 10002967 Term: Aplastic anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: ETB115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELTROMBOPAG
CAS Number: 496775-61-2
Current Sponsor code: ETB115
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Novartis Farmacéutica, S.ANot Recruiting Female: yes
Male: yes
50Phase 2Qatar;Hong Kong;Spain;Turkey;Italy;India;France;Hungary;Mexico;Canada;Brazil;Netherlands;Korea, Republic of
35EUCTR2016-003226-16-IT03/02/20175 February 2018Follow-up of phase I/II study of CaspaCide T cells from an HLA-partially matched family donor after negative selection of TCR aß+ T cells in pediatric patients affected by hematological disordersFollow-up of phase I/II study of CaspaCide T cells from an HLA-partially matched family donor after negative selection of TCR aß+ T cells in pediatric patients affected by hematological disorders - CaspaCide TCR aß haplo HSCTHematological disorders (ALL;AML;Non-Hodgkin lymphoma;Myelodysplastic syndromes;Congenital immune deficiencies;Severe aplastic anemia;Fanconi anemia; Osteopetrosis;Selected cases of hemoglobinopathies)
MedDRA version: 19.0 Level: HLGT Classification code 10018849 Term: Haematological disorders NEC System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: AP1903
Pharmaceutical Form: Solution for infusion
CAS Number: 195514-63-7
Current Sponsor code: AP1903
Other descriptive name: AP1903
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 0.4-
Bellicum Pharmaceuticals, Inc.AuthorisedFemale: yes
Male: yes
175Phase 1;Phase 2Italy
No.TrialIDDate_
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36NCT02838992February 201716 December 2017ATG 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 recruiting1 Year60 YearsAll130Phase 4China
37NCT02960646January 18, 201722 July 2019Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic MalignanciesPhase I Clinical Trial Using an Engineered Peripheral Blood Graft for Haploidentical TransplantationAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome;Acute Myeloid Leukemia in Remission;Adult Acute Lymphoblastic Leukemia in Complete Remission;Aplastic Anemia;Blasts Under 10 Percent of Bone Marrow Nucleated Cells;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Hematopoietic Cell Transplantation Recipient;Minimal Residual Disease;Myeloproliferative Neoplasm;Plasma Cell Myeloma;Recurrent Chronic Lymphocytic Leukemia;Recurrent Hodgkin Lymphoma;Recurrent Non-Hodgkin Lymphoma;Recurrent Plasma Cell Myeloma;Recurrent Small Lymphocytic Lymphoma;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)Recruiting18 Years65 YearsAll12Phase 1United States
38ChiCTR19000235092017-01-013 June 2019Allogeneic 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 Trialaplastic 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 MedicineRecruiting18Both1:50;2:50;3:50;Phase 0China
39NCT03055078January 201716 December 2017Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Aplastic AnemiaEvaluation of Safety and Efficacy in Patients With Aplastic Anemia by Transplantation of Umbilical Cord Derived Mesenchymal Stem CellsAplastic AnemiaBiological: mesenchymal stem cellsHebei Medical UniversityRecruiting14 Years60 YearsAll10Phase 1China
40NCT02979873December 19, 201611 November 2019Sirolimus (Rapamune ) for Relapse Prevention in People With Severe Aplastic Anemia Responsive to Immunosuppressive TherapyA Randomized Trial of Sirolimus (Rapamune(R)) for Relapse Prevention in Patients With Severe Aplastic Anemia Responsive to Immunosuppressive TherapySevere Aplastic AnemiaDrug: SirolimusNational Heart, Lung, and Blood Institute (NHLBI)Recruiting2 Years99 YearsAll118Phase 2United States
No.TrialIDDate_
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41NCT03413306December 10, 201614 October 2019Eltrombopag+hATG+CsA vs. hATG+CsA in Children With Severe AAA Phase II Multicenter Randomized Study of Eltrombopag Combined With Cyclosporine and hATG Versus hATG and CsA as First Line Treatment in Pediatric Patients With Severe Acquired Aplastic AnemiaAcquired Aplastic AnemiaDrug: Eltrombopag;Drug: IST (ATG + CsA)Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyRecruiting2 Years18 YearsAll100Phase 3Russian Federation
42NCT02875743December 7, 20164 February 2019King's Invasive Aspergillosis Study IIIncidence of Invasive Fungal Disease in Patients Receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole ProphylaxisAplastic Anemia;Leukemia, Myeloid, Acute;Myelodysplastic Syndromes;Bone Marrow TransplantationDrug: PosaconazoleKing's College Hospital NHS TrustNot recruiting18 YearsN/AAll120Phase 4United Kingdom
43EUCTR2016-001223-31-GB11/10/20163 April 2017Incidence of Invasive Fungal Disease in Patients receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole tablet ProphylaxisIncidence of Invasive Fungal Disease in Patients receiving Immunosuppressive Therapy, Intensive Chemotherapy or Reduced Intensity Haematopoietic Stem Cell Transplantation on Posaconazole Prophylaxis - King's Invasive Aspergillosis Study II (KIASII)Aplastic Anaemia, Myelodysplastic syndromes, Acute Myeloid Leukaemia undergoing immunosuppression therapy, high dose chemotherapy or reduced intensity stem cell transplantation
MedDRA version: 19.0 Level: LLT Classification code 10038271 Term: Refractory anaemia with excess blasts in transformation System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 19.0 Level: LLT Classification code 10059041 Term: Allogeneic peripheral haematopoietic stem cell transplant System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 19.0 Level: LLT Classification code 10067862 Term: Allogeneic stem cell transplantation System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 19.0 Level: PT Classification code 10038270 Term: Refractory anaemia with an excess of blasts System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 19.0 Level: LLT Classification code 10010776 Term: Constitutional aplastic anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 19.0 Level: LLT Classification code 10068063 Term: Aplastic anaemia relapse System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 19.0 Level: LLT Classification code 10036699 Term: Primary idiopathic aplastic anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 19.0 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 19.0 Level: PT Classification code 10001756 Term: Allogenic bone marrow transplantation therapy System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 19.0 Level: LLT Classification code 10000884 Term: Acute myeloid leukaemia NOS System Organ Class: 10029104 - ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Noxafil®
Product Name: Noxafil Gastro resistant tablets
Pharmaceutical Form: Tablet
King's College Hospital NHS Foundation TrustAuthorisedFemale: yes
Male: yes
Phase 4United Kingdom
44NCT02828592September 9, 201620 May 2019Haploidentical 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.Recruiting1 Year75 YearsAll20Phase 2United States
45NCT02833805September 201629 July 2019NMA 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: Mycophenolate mofetil;Drug: Tacrolimus;Radiation: Total body irradiation;Drug: Cyclophosphamide;Drug: Fludarabine;Drug: ThymoglobulinSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRecruitingN/AN/AAll20Phase 2United States
No.TrialIDDate_
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46ChiCTR-IOR-160087382016-08-0118 April 2017A single center, randomized, controlled, opened label study for evaluating Cyclosporin alone or combined with Stanozolol in the treatment of aplastic anemiaA single center, randomized, controlled, opened label study for evaluating Cyclosporin alone or combined with Stanozolol in the treatment of aplastic anemiaaplastic anemiaA:Cyclosporin;B:Cyclosporin and Stanozolol;The First Affiliated Hospital of Zhengzhou UniversityRecruiting1865BothA:100;B:100;OtherChina
47NCT02845596August 201620 May 2019Unrelated 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, MDRecruitingN/A25 YearsAll40N/AUnited States
48NCT02857530August 201615 August 2016Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic AnemiaEfficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic AnemiaAnemia, AplasticDrug: rhTPO;Drug: placeboTianjin Medical University General HospitalNot recruiting6 Years60 YearsBoth250Phase 2China
49NCT02773290May 201625 February 2019Study of Romiplostim(AMG531) in Subjects With Aplastic AnemiaPhase 2/3 Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia Refractory to or Ineligible for Immunosuppressive TherapyAplastic AnemiaBiological: RomiplostimKyowa Hakko Kirin Co., LtdNot recruiting20 YearsN/AAll46Phase 2/Phase 3Japan;Korea, Republic of
50JPRN-JapicCTI-16324301/2/201616 July 2019Phase 2/3 Study of AMG531 in Subjects with Aplastic AnemiaPhase 2/3 Study of AMG531 in Subjects with Aplastic Anemia Refractory to or Ineligible for Immunosuppressive TherapyAplastic AnemiaIntervention name : AMG531
INN of the intervention : Romiplostim
Dosage And administration of the intervention : Subcutaneous administration
Kyowa Hakko Kirin Co., Ltd.Not Recruiting20BOTH46Phase 2-3
No.TrialIDDate_
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51NCT02745717January 201624 September 2018The Efficacy of Immunosuppressive Therapy Combined With Cord Blood Transfusion in Treatment of Severe Aplastic AnemiaThe Efficacy of Immunosuppressive Therapy Combined With Cord Blood Transfusion in Treatment of Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: Thymoglobulin;Procedure: Cord blood;Drug: Cyclosporine Oral ProductShanghai General Hospital, Shanghai Jiao Tong University School of MedicineRuijin Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Shanghai Tongji Hospital, Tongji University School of Medicine;Zhejiang Provincial Hospital of TCMRecruitingN/A60 YearsAll120Phase 4China
52NCT02566304November 13, 201523 April 2019Reduced 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 mofetilSidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting18 YearsN/AAll30Phase 2United States
53NCT01861093October 16, 201511 November 2019Safety Study of Cord Blood Units for Stem Cell TransplantsA Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) Manufactured by the National Cord Blood Program (NCBP) and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult PatientsAplastic Anemia;Leukemia;Myelodysplastic Syndrome (MDS);LymphomaBiological: Cord Blood UnitsNational Heart, Lung, and Blood Institute (NHLBI)National Cancer Institute (NCI);National Institute of Allergy and Infectious Diseases (NIAID);National Cord Blood Program, New York Blood CenterRecruitingN/AN/AAll500Phase 2United States
54NCT02462252October 201516 December 2017Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic SyndromeA Phase IIA, Open-label Study Designed to Evaluate Efficacy and Safety of BL-8040 Followed by Anti-Thymocyte Globulin (hATG), Cyclosporine and Methylprednisolone in Adult Subjects With Aplastic Anemia (AA) or Hypoplastic Myelodysplastic Syndrome (MDS)Aplastic Anemia;Hypoplastic Myelodysplastic SyndromeDrug: BL-8040;Drug: horse anti-thymocyte globulin (hATG);Drug: Methylprednisolone;Drug: CyclosporineBioLineRx, Ltd.Recruiting18 YearsN/AAll25Phase 2United States
55NCT02099747July 201526 August 2019hATG+CsA vs hATG+CsA+Eltrombopag for SAAA Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients.Severe Aplastic AnemiaDrug: hATG;Drug: CsA;Drug: EltrombopagEuropean Group for Blood and Marrow TransplantationNovartis;PfizerNot recruiting15 YearsN/AAll202Phase 3France;Italy;Netherlands;Spain;Switzerland;United Kingdom;Germany
No.TrialIDDate_
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56NCT03016806June 20156 May 2019Umbilical Cord Blood Transplantation From Unrelated DonorsUmbilical Cord Blood Transplantation From Unrelated DonorsAcute Leukemia;Immune Deficiency Disorder;Congenital Hematological Disorder;Metabolism Disorder;Aplastic Anemia;Myelodysplastic Syndromes;Chronic Leukemia;Lymphoma;Multiple Myeloma;Solid TumorDrug: Melphalan;Drug: Fludarabine;Drug: Busulfan;Procedure: Cord Blood Infusion;Drug: Mesna;Drug: Cyclophosphamide;Radiation: Total Body Irradiation 200 cGy;Radiation: Total Body Irradiation 1200 cGyUniversity of RochesterRecruiting2 Months75 YearsAll30Phase 1United States
57NCT02404025May 201511 June 2018Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) SubjectsA Non-randomized, Phase II Study of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A (ATG/CsA) in Subjects With Moderate or More Severe Aplastic Anemia Who Have Not Received Prior ATG/Anti-lymphocyte Globulin (ALG)-Based Immunosuppressive TherapyCytopaeniaBiological: Eltrombopag;Biological: Rabbit ATG;Biological: CsANovartis PharmaceuticalsNot recruiting18 Years75 YearsAll11Phase 2Japan
58EUCTR2014-000174-19-DE27/01/20152 February 2015Efficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopag (Revolade®, GlaxoSmithKline) with Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin AEfficacy and Safety of Eltrombopag in Patients with Acquired Moderate Aplastic Anemia (EMAA) who are treated with Ciclosporin A Prospective Randomized Multicenter Study comparing Thrombopoetin-Receptor agonist Eltrombopag (Revolade®, GlaxoSmithKline) with Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin A - EMAAModerate Aplastic Anemia;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Trade Name: Revolade 75 mg
Product Name: Eltrombopag
Product Code: SB497115
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Eltrombopag
CAS Number: 496775-62-3
Current Sponsor code: SB497115
Other descriptive name: ELTROMBOPAG OLAMINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Universitätsklinikum UlmAuthorisedFemale: yes
Male: yes
116France;Netherlands;Germany;Italy;United Kingdom;Switzerland
59NCT02773225January 27, 201512 February 2018Efficacy and Safety of Eltrombopag + CSA in Patients With Moderate Aplastic Anemia (EMAA)Efficacy and Safety of Thrombopoetin-Receptor Agonist Eltrombopag in in Combination With Ciclosporin A in Moderate Aplastic Anemia (EMAA): Prospective Randomized Multicenter StudyAnemia, AplasticDrug: Eltrombopag;Drug: Placebo (for Eltrombopag)B. HöchsmannRecruiting18 YearsN/AAll116Phase 2/Phase 3Germany
60ChiCTR-IPR-140057202015-01-0118 April 2017A single center, Randomized controlled, opened clinical reserch for evaluating the effectiveness of recombinant human thrombopoietin combined with immunosuppressive therapy in the treatment of newly diagnosed acquired severe aplastic anemiaA single center, Randomized controlled, opened clinical reserch for evaluating the effectiveness of recombinant human thrombopoietin combined with immunosuppressive therapy in the treatment of newly diagnosed acquired severe aplastic anemiasevere aplastic anemiaTPO:rTPO;Ciclosporine:Ciclosporine;Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting1875BothTPO:86;Ciclosporine:86;Phase 1 studyChina
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61NCT02162420January 20157 October 2019Hematopoietic 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 MinnesotaRecruitingN/A70 YearsAll50N/AUnited States
62NCT02407470January 201513 April 2015Safety and Efficacy of Patient's Own AD-MSC and AD-HSC Transplantation in Patients With Severe Aplastic AnemiaA Multicenter, Randomized, Controlled Study of the Efficacy and Safety of the Combination of Adipose Tissue-derived Hematopoietic Stem Cells (AD-HSCs) and ATG in the Treatment of Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: Rabbit antithymoglobulin (ATG);Procedure: Adipose derived mesenchymal stem cells ( AD-MSCs);Procedure: AD-MSC transdifferentiated HSCs (AD-HSCs)Navy General Hospital, BeijingPeking Union Medical College Hospital;General Hospital of Beijing PLA Military Region;Chinese Academy of Medical SciencesRecruiting14 Years70 YearsBoth90Phase 1/Phase 2China
63NCT02203396August 201417 May 2016A Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic AnemiaA Single-Arm Phase 2 Study With Optimized Standard Protocol for Severe Aplastic AnemiaAplastic AnemiaDrug: rabbit ATG, Cyclosporine, LevamisoleYizhou ZhengRecruiting6 Years70 YearsBoth40Phase 2China
64NCT02224872August 201416 December 2017Transplantation 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 CenterRecruitingN/A73 YearsAll20Phase 2United States
65NCT02148133July 23, 201411 June 2018A Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic AnemiaA Non-randomized, Open-label, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic AnemiaCytopaeniaDrug: Eltrombopag 12.5 mg;Drug: Eltrombopag 25 mgNovartis PharmaceuticalsNot recruiting18 Years79 YearsAll21Phase 2Japan
No.TrialIDDate_
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66NCT01818726June 23, 201416 December 2017Safety and Efficacy of Exjade in the Treatment of Transfusion-dependent Iron Overload in Aplastic Anemia PatientsOpen-label Study of Exjade in the Treatment of Transfusion-dependent Iron Overload in Aplastic Anemia Patients Undergoing Treatment Programs in Comparison With Control GroupAplastic AnemiaDrug: ICL670A and standard immunosupressive therapy (Cyclosporine A);Drug: Immunosupressive therapy (Cyclosporine A)Novartis PharmaceuticalsNot recruiting18 YearsN/AAll14Phase 4Russian Federation
67NCT02094417April 14, 201424 September 2018A Phase 2 Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic AnemiaA Phase 2, Randomized, Open-Label, Parallel, Comparative, Dose-Finding Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia Subjects With Thrombocytopenia Refractory to Immunosuppressive TherapyAplastic AnemiaDrug: AMG531Kyowa Hakko Kirin Korea Co., Ltd.Not recruiting19 YearsN/AAll35Phase 2Korea, Republic of
68NCT02055456February 201414 December 2015Nandrolone Decanoate in the Treatment of TelomeropathiesMale Hormones for Telomere Related DiseasesAplastic Anemia;Bone Marrow Failure Syndromes;Idiopathic Pulmonary Fibrosis;Telomere ShorteningDrug: Nandrolone DecanoateUniversity of Sao PauloConselho Nacional de Desenvolvimento Científico e TecnológicoRecruiting2 YearsN/ABoth20Phase 1/Phase 2Brazil
69NCT01917708January 201419 November 2018BMT Abatacept for Non-Malignant DiseasesAbatacept for Post-Transplant Immune Suppression in Children and Adolescents Receiving Allogeneic Hematopoietic Stem Cell Transplants for Non-Malignant DiseasesHurler Syndrome;Fanconi Anemia;Glanzmann Thrombasthenia;Wiskott-Aldrich Syndrome;Chronic Granulomatous Disease;Severe Congenital Neutropenia;Leukocyte Adhesion Deficiency;Shwachman-Diamond Syndrome;Diamond-Blackfan Anemia;Dyskeratosis-congenita;Chediak-Higashi Syndrome;Severe Aplastic Anemia;Thalassemia Major;Hemophagocytic Lymphohistiocytosis;Sickle Cell DiseaseDrug: AbataceptEmory UniversityNot recruitingN/A21 YearsAll10Phase 1United States
70NCT02007811November 201319 February 2015Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single VaccinationProspective, Open-label, Multicentre Clinical Trial, Phase I/IIa, to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates CD3+-Depleted, CD19+-Enriched, Cryopreserved (Single Administration After Day 120 Following Allogeneic Stem Cell Transplantation (SCT), Donor-identical) in 4 Groups With Escalating Doses for Immune Response Enhancement, Measured as Response to a Antedated Single VaccinationAcute Myeloid Leukemia;Acute Lymphoblastic Leukemia;Chronic Myeloid Leukemia;Non Hodgkin's Lymphoma;Hodgkin's Disease;Myelodysplastic Syndrome;Multiple Myeloma;Aplastic AnemiaBiological: allogeneic donor derived B-lymphocytesUniversity of Erlangen-Nürnberg Medical SchoolUniversity Hospital Regensburg;Wuerzburg University Hospital;University Hospital, Essen;German Research FoundationRecruiting18 Years75 YearsBoth15Phase 1/Phase 2Germany
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71NCT02218437October 201319 February 2015Treatment Protocol of Child SAA With the Injection of Mesenchymal Stem Cells(Umbilical Cord Derived)Child With Severe Aplastic Anemia (SAA) Therapy: the Injection of Umbilical Cord Derived Mesenchymal Stem Cells.Complications of Organ Transplant Stem Cells Umbilical CordDrug: MSC+ATGChinese Academy of Medical SciencesRecruiting1 Month18 YearsBoth20Phase 4China
72NCT02028416September 201311 April 2016Comparison of Two Different Doses of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic AnaemiaProtocol for Comparison of Two Different Regimens of Rabbit ATG-Fresenius With Cyclosporin in the Treatment of Acquired Aplastic AnaemiaAplastic AnemiaDrug: ATG-freseniusNational Institute of Blood Disease Center, PakistanRecruiting2 Years65 YearsBoth60N/APakistan
73NCT02065154August 27, 201315 July 2019Post 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 BirminghamNot recruiting19 Years65 YearsAll41Phase 2United States
74NCT01891994June 28, 201320 August 2018Extended Dosing With Eltrombopag for Severe Aplastic AnemiaExtended Dosing With Eltrombopag in Refractory Severe Aplastic AnemiaSevere Aplastic Anemia (SAA)Drug: EltrombopagNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting2 Years100 YearsAll40Phase 2United States
75ChiCTR-PRC-130031302013-04-0118 April 2017Voriconazole tablet for primary prophylaxis of invasive fungal infection in patients with severe aplastic anemia: a prospective, randomized, controlled, multi-center trialThe efficacy and pharmacoeconimics of voriconazole tablet for primary prophylaxis of invasive fungal infection in patients with severe aplastic anemiaSevere Aplastic Anemia (SAA)Trial group:Vfend? (Voriconazole tablet for oral) should be administered 6mg/kg at the first day for adults, and then 200mg, twice daily; 4-7mg/kg/d for children, divided into twice a day,with administration period no longer than 6 weeks.;control:without anti-fungal drug;Institute of Hematology & Blood Diseases Hospital, CAMS & PUMCNot Recruiting365BothTrial group:50;control:50;Post-marketChina
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76NCT01586455April 20138 January 2018Human Placental-Derived Stem Cell TransplantationA Single-Arm Study to Assess the Safety of Transplantation With Human Placental-Derived Stem-Cells Combined With Unrelated and Related Cord Blood in Subjects With Certain Malignant Hematologic Diseases and Non-Malignant DisordersMucopolysaccharidosis I;Mucopolysaccharidosis VI;Adrenoleukodystrophy;Niemann-Pick Disease;Metachromatic Leukodystrophy;Wolman Disease;Krabbe's Disease;Gaucher's Disease;Fucosidosis;Batten Disease;Severe Aplastic Anemia;Diamond-Blackfan Anemia;Amegakaryocytic Thrombocytopenia;Myelodysplastic Syndrome;Acute Myelogenous Leukemia;Acute Lymphocytic LeukemiaDrug: Human Placental Derived Stem CellNew York Medical CollegeNot recruitingN/A55 YearsAll43Phase 1United States
77NCT01966367March 201325 March 2019CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell TransplantationCD34+ Stem Cell Selection for Patients Receiving a Matched or Partially Matched Family or Unrelated Adult Donor Allogeneic Stem Cell Transplantation for Non-Malignant DiseaseBone Marrow Failure Syndrome;Severe Aplastic Anemia;Severe Congenital Neutropenia;Amegakaryocytic Thrombocytopenia;Diamond-Blackfan Anemia;Schwachman Diamond Syndrome;Primary Immunodeficiency Syndromes;Acquired Immunodeficiency Syndromes;Histiocytic Syndrome;Familial Hemophagocytic Lymphocytosis;Lymphohistiocytosis;Macrophage Activation Syndrome;Langerhans Cell Histiocytosis (LCH);Hemoglobinopathies;Sickle Cell Disease;Sickle Cell-beta-thalassemiaBiological: CD34 Stem Cell Selection TherapyDiane George, MDRecruitingN/A40 YearsAll25Early Phase 1United States
78NCT02247973February 201319 February 2015Mesenchymal Stem Cells Co-transplantation in Alternative Donor Transplantation of Severe Aplastic Anemia.Phase?Trial of Co-transplantation With Bone Marrow Derived Mesenchymal Stem Cells From Related Donors in Alternative Donor Transplantation of Severe Aplastic Anemia.Severe Aplastic AnemiaBiological: mesenchymal stem cellsGuangzhou General Hospital of Guangzhou Military CommandGuangzhou First Municipal People’s Hospital;Nanfang Hospital of Southern Medical University;Southern Medical University, China;First Affiliated Hospital, Sun Yat-Sen University;Second Affiliated Hospital, Sun Yat-Sen University;Third Affiliated Hospital, Sun Yat-Sen University;Fifth Affiliated Hospital, Sun Yat-Sen University;Guangdong General Hospital;The Second People's Hospital of GuangDong Province;First Affiliated Hospital of Jinan University;The First Affiliated Hospital of Guangzhou Medical University;Second Affiliated Hospital of Guangzhou Medical University;Peking University Shenzhen Hospital;Shenzhen Second People's HospitalRecruiting14 Years50 YearsBoth100Phase 2China
79NCT01760096January 201319 February 2015Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)Phase II Study of the Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)Paroxysmal Nocturnal Hemoglobinuria;Hemoglobinuria;Hemoglobinuria, Paroxysmal;Proteinuria;Urination Disorders;Thrombosis;Bone Marrow Failure;Aplastic Anemia,;Anemia, HemolyticDrug: Levamisole+cyclosporin A+Glucocorticoids;Drug: cyclosporin A+Glucocorticoids;Drug: GlucocorticoidsInstitute of Hematology & Blood Diseases HospitalNot recruiting18 YearsN/ABoth50Phase 2China
80NCT01849237December 201219 February 2015Russian Clinical Trial of Mesenchymal Cells in Patients With Septic Shock and Severe NeutropeniaRussian Single-center Open Randomized Clinical Trial of the Impact of Mesenchymal Stromal Cells Therapy on Organ Dysfunction and 28-day Mortality in Patients With Septic Shock and Severe Neutropenia.Septic Shock;Nonchemotherapy Drug-induced Neutropenia;Neutropenia After Chemotherapy in Oncohematological Patients;Neutropenia in Patients With Aplastic AnemiaGenetic: Mesenchymal stromal cells;Drug: Standard therapy of septic shockNational Research Center for Hematology, RussiaRecruiting17 Years75 YearsBoth30Phase 1/Phase 2Russian Federation
No.TrialIDDate_
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81NCT01703169November 201216 December 2017Efficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic AnemiaEfficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic AnemiaSevere Aplastic Anemia;Very Severe Aplastic Anemia;Moderate Aplastic AnemiaDrug: EltrombopagUniversity of UtahNovartisNot recruiting18 YearsN/AAll13Phase 2United States
82NCT01759732September 201219 February 2015Haploidentical 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 CenterRecruitingN/A21 YearsBoth10Phase 2Korea, Republic of
83NCT01623167July 2, 201222 October 2019Eltrombopag With Standard Immunosuppression for Severe Aplastic AnemiaEltrombopag Added to Standard Immunosuppression in Treatment-Naive Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: hATG/CsA /eltrombopag -Cohort 1;Drug: hATG/CsA /eltrombopag Cohort 2;Drug: hATG/CsA /eltrombopag Cohort 3National Heart, Lung, and Blood Institute (NHLBI)Recruiting2 Years95 YearsAll207Phase 1/Phase 2United States
84NCT01642979July 201219 February 2015Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal HemoglobinuriaPhase II Study of the Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal HemoglobinuriaParoxysmal Nocturnal Hemoglobinuria;Hemoglobinuria;Hemoglobinuria, Paroxysmal;Proteinuria;Urination Disorders;Thrombosis;Bone Marrow Failure;Aplastic Anemia,;Anemia, HemolyticDrug: Levamisole+cyclosporin A+Glucocorticoids;Drug: cyclosporin A+Glucocorticoids;Drug: GlucocorticoidsInstitute of Hematology & Blood Diseases HospitalNot recruiting18 YearsN/ABoth120Phase 2China
85NCT01659606July 201215 April 2019Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis CongenitaRadiation- and Alkylator-free Hematopoietic Cell Transplantation for Bone Marrow Failure Due to Dyskeratosis Congenita / Telomere DiseaseDyskeratosis Congenita;Hoyeraal Hreidarsson Syndrome;Revesz Syndrome;Aplastic AnemiaBiological: alemtuzumab;Drug: Fludarabine;Drug: Cyclosporins;Drug: Mycophenolate mofetilBoston Children’s HospitalDana-Farber Cancer Institute;Children's Hospital Medical Center, Cincinnati;Children's Hospital Los Angeles;Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium;Baylor College of Medicine;Children's Hospital of Philadelphia;Memorial Sloan Kettering Cancer Center;University of Wisconsin, Madison;Karolinska University HospitalRecruitingN/A65 YearsAll40Phase 2United States;Sweden
No.TrialIDDate_
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86NCT01624805June 25, 201217 June 2019Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic SyndromePhase II Study of Horse Anti-Thymocyte Globulin (hATG), Cyclosporine, Methylprednisolone, and GCSF (Filgrastim or Pegfilgrastim) in Patients With Aplastic Anemia (AA), or Low/Int-1 Risk Myelodysplastic Syndrome (MDS)Aplastic Anemia;de Novo Myelodysplastic Syndrome;Myelodysplastic Syndrome;Previously Treated Myelodysplastic SyndromeBiological: Anti-Thymocyte Globulin;Drug: Cyclosporine;Biological: Filgrastim;Drug: Methylprednisolone;Biological: PegfilgrastimM.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingN/AN/AAll100Phase 2United States
87NCT01844635May 201211 April 2016Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAAA Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic AnemiaAcquired Aplastic Anemia.Drug: ThymoglobulinNagoya UniversityRecruitingN/A69 YearsBoth320Phase 3Japan
88EUCTR2011-005152-34-ES26/03/20122 October 2017Clinical trial to reduce duration of antibiotic therapy in in-hospital patients with haematological diseases that develop fever and low white blood cell count (neutropenia).Randomized open label clinical trial directed to optimize the duration of empirical antimicrobial therapy in haematologic patients with febrile neutropeniaIn-hospital adult patients diagnosed with acute leukemia, lymphoproliferative syndrome, multiple myeloma, myelodysplastic syndrome, aplastic anemia or who have received autologous or allogeneic transplantation of hematopoietic progenitors, with febrile neutropenia without etiological diagnosis.
MedDRA version: 14.0 Level: PT Classification code 10016288 Term: Febrile neutropenia System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.0 Level: LLT Classification code 10066156 Term: Empiric treatment System Organ Class: 10042613 - Surgical and medical procedures ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: ACICLOVIR
CAS Number: 59277-89-3
Current Sponsor code: NA
Other descriptive name: ACICLOVIR
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 5-10
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AMIKACIN
CAS Number: 37517-28-5
Current Sponsor code: NA
Other descriptive name: AMIKACIN
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 20-
Pharmaceutical Form: Powder for solution for injection or infusion
INN or Proposed INN: AMPHOTERICINE B, LIPOSOME
CAS Number: 8000078-82-2
Current Sponsor code: NA
Other descriptive name: AMPHOTERICINE B, LIPOSOME
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 3-10
Pharmaceutical Form: Powder for solution for injection or infusion
INN or Proposed INN: CASPOFUNGIN ACETATE
CAS Number: 179463-17-3
Current Sponsor code: NA
Other descriptive name: CASPOFUNGIN ACETATE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 50-70
Pharmaceutical Form: Powder for solution for injection or infusion
INN or Proposed INN: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 6-
Pharmaceutical Form: Solution for infusion and oral solution
INN or Proposed INN: CIPROFLOXACIN
CAS Number: 85721-33-1
Current Sponsor code: NA
Other descriptive name: CIPROFLOXACIN
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 800-1500
Pharmaceutical Form: Tablet
INN or Proposed INN: TRIMETHOPRIM SULFATE
CAS Number: 56585-33-2
Current Sponsor code: NA
Other descriptive name: TRIMETHOPRIM SULFATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 160-
José Miguel Cisneros HerrerosNot RecruitingFemale: yes
Male: yes
Phase 3Spain
89NCT01995331March 201219 February 2015Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic AnemiaModerate-dose Cyclophosphamide for Childhood Acquired Aplastic AnemiaAplastic AnemiaDrug: cyclophosphamide,cyclosporine AXiaofan ZhuNot recruiting1 Year18 YearsBoth30Phase 4China
90NCT01529827February 28, 201230 September 2019Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic MalignanciesA Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body IrradiationPrimary Myelofibrosis;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 Adult T-cell Leukemia/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 Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Severe Combined Immunodeficiency;Severe Congenital Neutropenia;Shwachman-Diamond Syndrome;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich Syndrome;Chronic Phase Chronic Myelogenous Leukemia;Congenital Amegakaryocytic Thrombocytopenia;Diamond-Blackfan Anemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Juvenile Myelomonocytic Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Paroxysmal Nocturnal Hemoglobinuria;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Accelerated Phase Chronic Myelogenous Leukemia;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);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 Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Burkitt Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic LeukemiaDrug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Drug: methotrexate;Other: laboratory biomarker analysis;Procedure: allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationRoswell Park Cancer InstituteNot recruiting3 Years75 YearsAll94Phase 2United States
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91NCT01553461February 21, 201215 July 2019Transplants With Unlicensed Preserved Cord BloodA Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other IndicationsMyelodysplastic Syndrome (MDS);Hematologic Neoplasms;Hematologic Diseases;Severe Aplastic AnemiaDrug: Cord Blood TransplantNational Heart, Lung, and Blood Institute (NHLBI)RecruitingN/A99 YearsAll500Phase 1/Phase 2United States
92NCT01500161November 201119 February 2015Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-MatchA Phase II Study Of Pooled Unrelated Donor Umbilical Cord Blood (UCB) Transplant For Patients With Hematologic Malignancies Needing Allogeneic Stem Cell Transplant But Do Not Have A Related HLA-Matched DonorAcute Myelogenous Leukemia;Acute Lymphocytic Leukemia;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia;Hodgkins Disease;Non-Hodgkins Lymphoma;Aplastic Anemia;Multiple Myeloma;Myelodysplastic SyndromeDrug: Busulfan;Drug: Clofarabine;Drug: Fludarabine;Drug: Melphalan;Drug: Carmustine;Drug: Etoposide;Drug: CytarabineTexas Oncology Cancer CenterNot recruiting18 Years65 YearsBoth1Phase 2United States
93NCT01351545October 20118 April 2019A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other IndicationsHematologic Malignancies;Inherited Disorders of Metabolism;Inherited Abnormalities of Platelets;Histiocytic Disorders;Acute Myelogenous Leukemia (AML or ANLL);Acute Lymphoblastic Leukemia (ALL);Other Acute Leukemia;Chronic Myelogenous Leukemia (CML);Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases;Other Leukemia;Hodgkin Lymphoma;Non-hodgkin Lymphoma;Multiple Myeloma/ Plasma Cell Disorder (PCD);Inherited Abnormalities of Erythrocyte Differentiation or Function;Disorders of the Immune System;Automimmune Diseases;Severe Aplastic AnemiaDrug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)Center for International Blood and Marrow Transplant ResearchNational Marrow Donor ProgramRecruitingN/AN/AAll99999N/AUnited States
94NCT01472055October 201119 February 2015Pharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell TransplantationPharmacokinetic Study of Fludarabine in Pediatric Hematopoietic Stem Cell TransplantationAcute Leukemia;Chronic Leukemia;Severe Aplastic AnemiaDrug: FludarabineSeoul National University HospitalMinistry of Food and Drug Safety, KoreaRecruitingN/A19 YearsBoth46Phase 2Korea, Republic of
95NCT01546415October 201119 February 2015Safety and Efficacy of Desferasirox in Chinese Patients With Iron Overload and Aplastic AnemiaA Single Arm, Multicenter, Open Label Study of Desferasirox in Chinese Patients With Iron Overload and Aplastic AnemiaIron OverloadDrug: DesferasiroxNovartis PharmaceuticalsNot recruiting18 YearsN/ABoth64Phase 4China
No.TrialIDDate_
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96NCT01384513August 4, 201116 December 2017A 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 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;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 MacroglobulinemiaDrug: 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 UniversityRecruiting18 YearsN/AAll50Phase 2United States
97JPRN-UMIN0000060712011/08/012 April 2019Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulinSAAConditioning 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 TherapyNot Recruiting16years-old65years-oldMale and Female28Phase 2Japan
98NCT01441037July 19, 201120 August 2018Danazol for Genetic Bone Marrow and Lung DisordersMale Hormones for Telomere Related DiseasesAplastic AnemiaDrug: DanazolNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting2 YearsN/AAll27Phase 1/Phase 2United States
99NCT01408342July 201119 February 2015Alemtuzumab and Rituximab in Aplastic AnemiaLow-doses Alemtuzumab and Rituximab Combination as First Line Treatment in Aplastic AnemiaAplastic AnemiaDrug: Alemtuzumab and RituximabHospital Universitario Dr. Jose E. GonzalezNot recruiting12 MonthsN/ABoth0N/AMexico
100NCT01267643May 20115 February 2018Alefacept in Patients With Relapsed/Refractory Aplastic AnemiaA Phase 1/2 Study of Alefacept, a CD2 Receptor Antagonist in Patients With Relapsed/Refractory Aplastic AnemiaAplastic AnemiaDrug: AlefaceptThe Cleveland ClinicAstellas Pharma US, Inc.Not recruiting18 YearsN/AAll4Phase 1United States
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101NCT01328587April 1, 20115 November 2018Eltrombopag for Moderate Aplastic AnemiaA Pilot Study of a Thrombopoietin-Receptor Agonist (TPO-R Agonist), Eltrombopag, in Moderate Aplastic Anemia PatientsModerate Aplastic Anemia;Unilineage Bone Marrow Failure DisordersDrug: EltrombopagNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting2 Years100 YearsAll33Phase 2United States
102NCT01343680April 201119 February 2015Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology PatientsA Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, CanadaChildhood Cancer;Aplastic Anemia;Metabolic DisordersDrug: Heparin;Drug: Normal salineAlberta Children's HospitalStollery Children's HospitalNot recruitingN/A17 YearsBoth2Phase 3Canada
103NCT01297972February 201119 February 2015Mesenchymal Stem Cells in the Treatment of Relapsed/Refractory Severe Acquired Aplastic AnemiaBone Marrow Mesenchymal Stem Cells in the Treatment of Refractory Severe Acquired Aplastic AnemiaAplastic AnemiaBiological: Intravenous bone marrow mesenchymal stem cells infusionUniversity of Sao PauloNot recruiting18 Years65 YearsBoth9Phase 1/Phase 2Brazil
104NCT01305694February 201119 February 2015Mesenchymal Stem Cells Transplantation to Patients With Relapsed/Refractory Aplastic Anemia.Phase?/?Trial of Bone Marrow Derived Mesenchymal Stem Cell Transplantation From Related Donor to Patients With Relapsed/Refractory Aplastic Anemia.Aplastic AnemiaBiological: bone marrow derived mesenchymal stem cellsGuangzhou General Hospital of Guangzhou Military CommandGuangzhou Municipal Twelfth People's Hospital;Guangdong Prevention and Treatment Center for Occupational DiseasesRecruiting16 YearsN/ABoth50Phase 1/Phase 2China
105NCT01199562December 20106 May 2019Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell TransplantModified Preemptive CMV Management Strategy After Allogeneic Hematopoietic Cell Transplantation and Laboratory Correlation With Innate Immune FunctionHematopoietic/Lymphoid Cancer;Accelerated Phase Chronic Myelogenous Leukemia;Acute Undifferentiated Leukemia;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);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 Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Atypical Chronic Myeloid Leukemia, BCR-ABL Negative;Blastic Phase Chronic Myelogenous Leukemia;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Contiguous Stage II Adult Burkitt Lymphoma;Contiguous Stage II Adult Diffuse Large Cell Lymphoma;Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Contiguous Stage II Adult Lymphoblastic Lymphoma;Contiguous Stage II Grade 1 Follicular Lymphoma;Contiguous Stage II Grade 2 Follicular Lymphoma;Contiguous Stage II Grade 3 Follicular Lymphoma;Contiguous Stage II Mantle Cell Lymphoma;Contiguous Stage II Marginal Zone Lymphoma;Contiguous Stage II Small Lymphocytic Lymphoma;Cutaneous B-cell Non-Hodgkin Lymphoma;Cytomegalovirus Infection;de Novo Myelodysplastic Syndromes;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Mast Cell Leukemia;Meningeal Chronic Myelogenous Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Noncontiguous Stage II Adult Burkitt Lymphoma;Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Noncontiguous Stage II Adult Lymphoblastic Lymphoma;Noncontiguous Stage II Grade 1 Follicular Lymphoma;Noncontiguous Stage II Grade 2 Follicular Lymphoma;Noncontiguous Stage II Grade 3 Follicular Lymphoma;Noncontiguous Stage II Mantle Cell Lymphoma;Noncontiguous Stage II Marginal Zone Lymphoma;Noncontiguous Stage II Small Lymphocytic Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;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 Adult T-cell Leukemia/Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Relapsing Chronic Myelogenous Leukemia;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Splenic Marginal Zone Lymphoma;Stage 0 Chronic Lymphocytic Leukemia;Stage I Adult Burkitt Lymphoma;Stage I Adult Diffuse Large Cell Lymphoma;Stage I Adult Diffuse Mixed Cell Lymphoma;Stage I Adult Diffuse Small Cleaved Cell Lymphoma;Stage I Adult Hodgkin Lymphoma;Stage I Adult Immunoblastic Large Cell Lymphoma;Stage I Adult Lymphoblastic Lymphoma;Stage I Adult T-cell Leukemia/Lymphoma;Stage I Chronic Lymphocytic Leukemia;Stage I Cutaneous T-cell Non-Hodgkin Lymphoma;Stage I Grade 1 Follicular Lymphoma;Stage I Grade 2 Follicular Lymphoma;Stage I Grade 3 Follicular Lymphoma;Stage I Mantle Cell Lymphoma;Stage I Marginal Zone Lymphoma;Stage I Multiple Myeloma;Stage I Mycosis Fungoides/Sezary Syndrome;Stage I Small Lymphocytic Lymphoma;Stage II Adult Hodgkin Lymphoma;Stage II Adult T-cell Leukemia/Lymphoma;Stage II Chronic Lymphocytic Leukemia;Stage II Cutaneous T-cell Non-Hodgkin Lymphoma;Stage II Multiple Myeloma;Stage II Mycosis Fungoides/Sezary Syndrome;Stage III Adult Burkitt Lymphoma;Stage III Adult Diffuse Large Cell Lymphoma;Stage III Adult Diffuse Mixed Cell Lymphoma;Stage III Adult Diffuse Small Cleaved Cell Lymphoma;Stage III Adult Hodgkin Lymphoma;Stage III Adult Immunoblastic Large Cell Lymphoma;Stage III Adult Lymphoblastic Lymphoma;Stage III Adult T-cell Leukemia/Lymphoma;Stage III Chronic Lymphocytic Leukemia;Stage III Cutaneous T-cell Non-Hodgkin Lymphoma;Stage III Grade 1 Follicular Lymphoma;Stage III Grade 2 Follicular Lymphoma;Stage III Grade 3 Follicular Lymphoma;Stage III Mantle Cell Lymphoma;Stage III Marginal Zone Lymphoma;Stage III Multiple Myeloma;Stage III Mycosis Fungoides/Sezary Syndrome;Stage III Small Lymphocytic Lymphoma;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Large Cell Lymphoma;Stage IV Adult Diffuse Mixed Cell Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Hodgkin Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Adult T-cell Leukemia/Lymphoma;Stage IV Chronic Lymphocytic Leukemia;Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Mycosis Fungoides/Sezary Syndrome;Stage IV Small Lymphocytic Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom MacroglobulinemiaProcedure: infection prophylaxis and management;Other: laboratory biomarker analysis;Other: flow cytometry;Genetic: DNA analysis;Genetic: RNA analysis;Procedure: management of therapy complications;Drug: ganciclovir;Drug: valganciclovir;Drug: foscarnet sodium;Procedure: antiviral therapy;Genetic: polymerase chain reaction;Genetic: protein expression analysisCity of Hope Medical CenterNational Cancer Institute (NCI)Not recruiting18 YearsN/AAll153Phase 3United States
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106JPRN-UMIN0000042642010/11/012 April 2019A Pharmacokinetics (PK)/Phase I study of intravenous (i.v.) administration of mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis after allogeneic hematopoietic stem cell transplantation (allo-SCT)Refractory hematologic disorders, including 1. Acute myelogenous leukemia 2. Acute lymphoblastic leukemia 3. Myelodysplastic syndrome 4. Chronic myelogenous leukemia 5. Malignant lymphoma 6. Aplastic anemiaFor GVHD prophylaxis, MMF is administered 4-6 h after allo-SCT at a dose of 1000 mg i.v. (diluted to a concentration of 6 mg/ml using 5% Dextrose, over 2 h) thrice daily (or twice daily in the case of cord blood transplantation) from day 0 to day 10 (for up to 14 days). Thereafter, patients are changed to p.o. MMF at the same dose and interval. After day 31, the dose tapers depending on individual risk factors for GVHD.
Blood samples (2 ml) for PK analysis are collected in EDTA tubes at 0, 0.5, 1, 2, 4, 8, and 12 h after the morning dose on days 2 and 9 during i.v. MMF administration and at 0, 1, 2, 4, 8, and 12 h on day 16 during p.o. MMF administration.
Total mycophenolic acid (MPA) levels are quantified by reverse-phase HPLC.
After quantification, non-compartmental analyses of total MPA concentration time data are conducted to estimate the AUC.
Kobe University Graduate School of MedicineSchool of Pharmacy and Pharmaceutical Science, Mukogawa Women's UniversityNot Recruiting15years-old69years-oldMale and Female10Not selectedJapan
107NCT01319851September 201016 December 2017Alefacept and Allogeneic Hematopoietic Stem Cell TransplantationAlefacept and Allogeneic Hematopoietic Stem Cell Transplantation for Children With Non-Malignant Diseases Who Have Been Multiply Transfused: a Pilot StudyThalassemia;Sickle Cell Disease;Glanzmann Thrombasthenia;Wiskott-Aldrich Syndrome;Chronic-granulomatous Disease;Severe Congenital Neutropenia;Leukocyte Adhesion Deficiency;Schwachman-Diamond Syndrome;Diamond-Blackfan Anemia;Fanconi Anemia;Dyskeratosis-congenita;Chediak-Higashi Syndrome;Severe Aplastic AnemiaDrug: AlefaceptEmory UniversityChildren's Healthcare of AtlantaNot recruitingN/A21 YearsAll3N/AUnited States
108NCT01182662August 201019 February 2015Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Severe Aplastic AnemiaPhase II Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat SAAAplastic AnemiaOther: Human umbilical cord-derived MSCs and cyclosporin A;Other: cyclosporin AShandong UniversityNational Natural Science Foundation of ChinaRecruiting18 Years80 YearsBoth30Phase 2China
109NCT01187017August 201019 October 2017A 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)Not recruiting2 YearsN/AAll1Phase 1/Phase 2United States
110NCT01191749August 201016 December 2017Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)Phase II Pilot Study Of Alemtuzumab In Patients With Low Or INT-1 Risk Myelodysplastic Syndrome (MDS), Aplastic Anemia (AA), Or T-Cell Large Granular Lymphocytic Leukemia (T-LGL)LeukemiaDrug: AlemtuzumabM.D. Anderson Cancer CenterNot recruitingN/AN/AAll7Phase 2United States
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111NCT01193283August 201016 December 2017Cyclophosphamide 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)Not recruiting2 YearsN/AAll22Phase 1/Phase 2United States
112NCT01350245July 201019 October 2017Bone 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 UniversityNot recruiting18 YearsN/AAll28Phase 2United States
113NCT01145976March 201019 February 2015Comparison 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 HematologyRecruiting15 Years65 YearsBoth98Phase 3Korea, Republic of
114NCT01129323November 200919 February 2015Reduced-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 CenterNot recruitingN/A21 YearsBoth0N/AUnited States
115EUCTR2008-005594-35-BE28/10/200927 January 2014Randomized double-blind study of mesenchymal stem cells (MSC) in patients undergoing matched unrelated allogeneic bone marrow or peripheral blood stem cell transplantation- A European multicentre study. - NARandomized double-blind study of mesenchymal stem cells (MSC) in patients undergoing matched unrelated allogeneic bone marrow or peripheral blood stem cell transplantation- A European multicentre study. - NAHematological disorders of the following types: ALL: acute lymphoblastic leukemia in complete remission (<5% blasts in marrow) up to and including third remission (excluding relapse). AML: acute myelocytic leukemia in remission (excluding relapse). CML: chronic myelocytic leukemia who are in the chronic phase of the disease. Severe aplastic anemia, hemoglobinopathies (thalassemia major). Inborn errors of metabolism. Myelodysplastic syndromes
MedDRA version: 9.1 Level: LLT Classification code 10027703 Term: Mismatched donor bone marrow transplantation therapy
Product Name: Mesenchymal stem cells
Product Code: MSC
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous use
CHU Sart-TilmanAuthorisedFemale: yes
Male: yes
172Belgium
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116NCT00987480September 25, 200916 December 2017Hematopoietic 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 CenterNot recruitingN/AN/AAll11Phase 2United States
117NCT00944749July 200916 December 2017Horse ATG/CsA in Aplastic Anemia Patients Unresponsive to or With a Suboptimal Response to Rabbit ATG/CsA TreatmentHorse ATG/CsA in Aplastic Anemia Patients Unresponsive to or With a Suboptimal Response to Rabbit ATG/CsA TreatmentAnemia, Aplastic;Anemia, HypoplasticDrug: h-ATG (ATGAM );Drug: Cyclosporine (Gengraf )National Heart, Lung, and Blood Institute (NHLBI)Not recruiting2 Years82 YearsAll23Phase 2United States
118NCT01105273July 200919 February 2015Human 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 CenterNot recruitingN/A21 YearsBoth12Phase 1/Phase 2Korea, Republic of
119NCT01224496July 200916 December 2017Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological DisordersTraditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological DisordersMyelodysplastic Syndrome (MDS);Aplastic Anaemia (AA);Myelofibrosis (MF);Thalassemia IntermediaDrug: Chinese herbal concoction twice a day for 6 monthsSingapore General HospitalShanghai Yueyang Integrated Medicine Hospital;Singapore Bao Zhong Tang TCM CenterNot recruiting13 Years85 YearsAll38Phase 1/Phase 2Singapore
120NCT00922883May 29, 200925 March 2019A Pilot Study of the Thrombopoietin-Receptor Agonist Eltrombopag in Refractory Aplastic Anemia PatientsA Pilot Study of a Thrombopoietin-Receptor Agonist (TPO-R Agonist), Eltrombopag, in Aplastic Anemia Patients With Immunosuppressive-Therapy Refractory ThrombocytopeniaAnemia, Aplastic;Anemia, Hypoplastic;ThrombocytopeniaDrug: EltrombopagNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting12 YearsN/AAll43Phase 2United States
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121EUCTR2009-012746-23-IT12/05/200919 March 2012pilot study of second line therapy for AAA Acquired Aplastic Anemia with antithymocyte globulin, cyclosporin and etanercept - NDpilot study of second line therapy for AAA Acquired Aplastic Anemia with antithymocyte globulin, cyclosporin and etanercept - NDacquired aplastic anemia
MedDRA version: 9.1 Level: SOC Classification code 10005329
Trade Name: ENBREL*SC 4FL 25MG+4SIR 1ML
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Etanercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
ISTITUTO GIANNINA GASLINIAuthorisedFemale: yes
Male: yes
Italy
122NCT00856388January 14, 200918 December 2018Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure DisordersA Pilot Trial Of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan, And Low Dose Total Body IrradiationAccelerated Phase Chronic Myelogenous Leukemia;Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome;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);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;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;de Novo Myelodysplastic Syndromes;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Fanconi Anemia;Juvenile Myelomonocytic Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Noncontiguous Stage II Adult Burkitt Lymphoma;Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Noncontiguous Stage II Adult Lymphoblastic Lymphoma;Noncontiguous Stage II Grade 1 Follicular Lymphoma;Noncontiguous Stage II Grade 2 Follicular Lymphoma;Noncontiguous Stage II Grade 3 Follicular Lymphoma;Noncontiguous Stage II Mantle Cell Lymphoma;Noncontiguous Stage II Marginal Zone Lymphoma;Noncontiguous Stage II Small Lymphocytic Lymphoma;Paroxysmal Nocturnal Hemoglobinuria;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;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 Adult T-cell Leukemia/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 Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Multiple Myeloma;Relapsing Chronic Myelogenous Leukemia;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Splenic Marginal Zone Lymphoma;Stage III Adult Diffuse Small Cleaved Cell Lymphoma;Stage III Adult Immunoblastic Large Cell Lymphoma;Stage III Adult Lymphoblastic Lymphoma;Stage III Grade 1 Follicular Lymphoma;Stage III Grade 2 Follicular Lymphoma;Stage III Grade 3 Follicular Lymphoma;Stage III Mantle Cell Lymphoma;Stage III Marginal Zone Lymphoma;Stage III Small Lymphocytic Lymphoma;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Small Lymphocytic Lymphoma;Waldenström MacroglobulinemiaProcedure: allogeneic hematopoietic stem cell transplantation;Biological: anti-thymocyte globulin;Drug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiationRoswell Park Cancer InstituteNational Cancer Institute (NCI)Not recruiting3 Years75 YearsAll62N/AUnited States
123NCT00993694January 200916 December 2017Methemoglobinemia in Young Patients With Hematologic Cancer or Aplastic Anemia Treated With DapsoneDapsone Induced Methemoglobinemia in Pediatric Hematologic Malignancy and Aplastic AnemiaChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Lymphoproliferative Disorder;Methemoglobinemia;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Neoplasms;Nonmalignant NeoplasmDrug: chemotherapy;Drug: dapsone;Other: medical chart review;Procedure: assessment of therapy complicationsVanderbilt UniversityNational Cancer Institute (NCI)Not recruitingN/A18 YearsAll41N/AUnited States
124NCT00882323November 200819 February 2015Reduced 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 OncologyRecruiting1 Year21 YearsBoth33Phase 2Korea, Republic of
125NCT00471848August 200819 February 2015Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic AnaemiaProspective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia and Comparison With Matched Historical Patients Treated With Horse ATG and CiclosporinAplastic AnemiaDrug: rabbit antithymocyte globulinEuropean Group for Blood and Marrow TransplantationGenzyme, a Sanofi CompanyNot recruiting16 YearsN/ABoth35Phase 2France;Germany;Italy;Saudi Arabia;Switzerland;United Kingdom
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126NCT00604201May 21, 200811 November 2019Stem Cell Transplant Using Peripheral and Cord Blood Stem Cells to Treat Severe Aplastic Anemia and Myelopdysplastic SyndromeCo-Infusion of Umbilical Cord Blood and Haploidentical CD34+ Cells Following Nonmyeloablative Conditioning as Treatment for Severe Aplastic Anemia and MDS Associated With Severe Neutropenia Refractory to Immunosuppressive TherapyMyelodysplastic Syndrome (MDS) With Refractory Anemia (RA);Severe Aplastic Anemia (SAA)Biological: Umbilical Cord BloodNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting4 Years75 YearsAll67Phase 2United States
127NCT01530555April 200814 March 2016Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic AnaemiaProspective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic AnaemiaAcquired Aplastic AnaemiaDrug: Rabbit ATG, Thymoglobuline (Genzyme)King Faisal Specialist Hospital & Research CenterNot recruiting16 Years80 YearsBoth35Phase 2
128EUCTR2007-001657-26-GB29/02/200826 November 2018Single 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 lymphoma 4. Hodgkin’s disease 5. Chronic lymphocytic leukaemia. 6. Acquired bone marrow failure syndromes 7. 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 Level: LLT Classification code 10028533 Term: Myelodysplastic syndrome
MedDRA version: 9.1 Level: LLT Classification code 10009013 Term: Chronic myeloid leukaemia
MedDRA version: 9.1 Level: LLT Classification code 10000844 Term: Acute lymphoblastic leukaemia
MedDRA version: 9.1 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma
MedDRA version: 9.1 Level: LLT Classification code 10029593 Term: Non-Hodgkin's lymphoma NOS
MedDRA version: 9.1 Level: LLT Classification code 10003892 Term: B-cell chronic lymphocytic leukaemia/prolymphocytic leukaemia/small lymphocytic lymphoma
MedDRA version: 9.1 Level: LLT Classification code 10002968 Term: Aplastic anaemia, unspecified
Trade Name: Fludarabine
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: FLUDARABINE PHOSPHATE
CAS Number: 75607-67-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Trade Name: Busilvex
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BUSULFAN
CAS Number: 55-98-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-
Trade Name: Thymoglobulin
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 0
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Thiotepa
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: THIOTEPA
CAS Number: 52244
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Trade Name: Cyclophosphamide
Pharmaceutical Form: Powder and solvent for solution for infusion
CAS Number: 6055192
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Trade Name: Alkeran
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: MELPHALAN
CAS Number: 148-82-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
King's College Hospital NHS Foundation TrustNot RecruitingFemale: yes
Male: yes
27Phase 2United Kingdom
129NCT00556400November 200719 October 2017Treatment of Menorrhagia in Women With Thrombocytopenia Using Platelets or Platelets and HormonesTreatment of Menorrhagia in Women With Thrombocytopenia: Comparison of Platelet Transfusion Alone to Platelet Transfusion With Continuous Oral Contraceptive PillsAplastic Anemia;Menorrhagia;AmenorrheaDrug: Lo-Ovral Oral Contraceptive Pills;Drug: Placebo - sugar pillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Not recruiting12 Years55 YearsFemale1Phase 1/Phase 2United States
130NCT00455312August 200716 December 2017Stem 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 MinnesotaNot recruitingN/A70 YearsAll36Phase 2/Phase 3United States
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131NCT00673114August 200719 October 2017Unrelated Cord Blood Transplant Plus a Haplo-Identical (Half-Matched), T-Cell Depleted Stem Transplant From a Related Donor for Subjects With High Risk MalignanciesA Prospective, Phase I/II Trial Determining the Efficacy and Safety of Allogeneic Hematopoietic Stem Cell Transplantation Using Banked Unrelated Umbilical Cord Blood Supplemented With Related, Haplo-Identical T-Cell Depleted Stem Cells in Subjects With High Risk MalignanciesHematologic Malignancy;Myelodysplastic Syndrome (MDS);Aplastic AnemiaBiological: haplo/cord transplantJoanne Kurtzberg, MDMiltenyi Biotec GmbHNot recruitingN/A55 YearsAll3Phase 1/Phase 2United States
132EUCTR2006-006577-25-SE25/07/200719 March 2012A prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantationA prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantationGraft versus host disease prophylaxis in patients receiving stem cell transplantation due to: chronic myeloid leukemia (CML) in 1st or 2nd chronic phase, acute myeloid leukemia (AML) in complete remission, acute lymphoblastic leukemia (ALL) in complete remission, myelodysplastic syndrome, chronic lymphocytic leukemia, lymphoma, non-malignant disorders, severe aplastic anemia, hemoglobinopathies and metabolic disorders
MedDRA version: 9.1 Level: LLT Classification code 10018799 Term: GVHD
Trade Name: Rapamune
Product Name: Rapamune
Pharmaceutical Form: Tablet
INN or Proposed INN: SIROLIMUS
CAS Number: 53123889
Other descriptive name: Rapamycin
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 3-12
Trade Name: Prograf
Product Name: Prograf
Pharmaceutical Form: Capsule*
INN or Proposed INN: TACROLIMUS
CAS Number: 104987113
Other descriptive name: FK-506
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 5-15
Trade Name: Sandimmun Neoral
Product Name: Sandimmun Neoral
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865133
Other descriptive name: CsA
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 100-300
Trade Name: Methotrexate
Product Name: Methotrexate
Pharmaceutical Form: Injection*
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Other descriptive name: MTX
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Karolinska InstitutetAuthorisedFemale: yes
Male: yes
200Finland;Sweden
133NCT00578266February 200716 December 2017Allogeneic 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 ClinicNot recruitingN/A60 YearsAll8Phase 1United States
134NCT00895739June 200619 February 2015Alemtuzumab and Low-Dose Cyclosporine in Treating Patients With Severe Aplastic Anemia or Acquired Marrow FailureAlemtuzumab and Low-Dose Cyclosporine-A as Alternative Immunosuppressive Treatment for Severe Aplastic Anemia (SAA) and Single-Lineage Aplastic PatientsNonmalignant NeoplasmBiological: alemtuzumab;Drug: cyclosporineFederico II UniversityRecruiting18 YearsN/ABoth50Phase 2Italy
135NCT00358657May 24, 200628 October 2019Fludarabine 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)Not recruitingN/A55 YearsAll14Phase 2United States
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136NCT00319878May 200619 February 2015Sirolimus and Cyclosporine for Treatment-Resistant Aplastic AnemiaA Phase I/II Trial of Sirolimus (Rapamune) and Cyclosporine in Patients With Refractory Aplastic AnemiaAnemia, AplasticDrug: Sirolimus;Drug: CyclosporineOffice of Rare Diseases (ORD)Rare Diseases Clinical Research NetworkRecruiting21 YearsN/ABoth52Phase 1/Phase 2United States
137NCT00474747February 7, 200616 December 2017Fludarabine-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)Not recruitingN/A65 YearsAll5Phase 1/Phase 2United States
138NCT00343785February 200616 December 2017Cyclophosphamide 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)Not recruitingN/A65 YearsAll21Phase 2United States;Canada
139NCT00354419February 200619 February 2015Cyclophosphamide, 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)Not recruitingN/A40 YearsBoth30Phase 1United States
140NCT00326417January 200616 December 2017Fludarabine-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 ProgramNot recruitingN/A65 YearsAll97Phase 1/Phase 2United States
No.TrialIDDate_
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141NCT00737685January 200619 February 2015Flu+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 OncologyNot recruitingN/A25 YearsBoth30Phase 2Korea, Republic of
142NCT00260689November 28, 200516 December 2017Three Immunosuppressive Treatment Regimens for Severe Aplastic AnemiaA Randomized Study of Three Immunosuppressive Regimens in Treatment Naive Patients With Severe Aplastic Anemia: Horse ATG/CsA Taper vs Rabbit-ATG/CsA vs AlemtuzumabImmunosuppresion;Thrombocytopenia;Pancytopenia;NeutropeniaBiological: Anti-thymocyte globulin (rabbit);Biological: Anti-thymocyte globulin (horse);Drug: Cyclosporine;Drug: AlemtuzumabNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting2 YearsN/AAll136Phase 2United States
143NCT00438178October 200519 February 2015Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological MalignanciesA Phase I Study of Obatoclax Mesylate (GX15-070MS) in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myeloid Leukemia (CML)in Myeloid Blast Phase, Myelofibrosis, Previously-Treated Chronic Lymphocytic Leukemia (CLL), or Aplastic AnemiaHematological MalignanciesDrug: Obatoclax mesylate (GX15-070MS)Gemin XNot recruiting18 YearsN/ABoth44Phase 1United States;Canada
144NCT00195624September 15, 20055 November 2018Alemtuzumab to Treat Severe Aplastic AnemiaA Pilot Study of Alemtuzumab (Campath) in Patients With Relapsed or Refractory Severe Aplastic AnemiaSevere Aplastic Anemia, Refractory;Severe Aplastic Anemia, RelapseBiological: Alemtuzumab (Campath );Drug: CyclosporineNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting2 Years110 YearsAll47Phase 2United States
145NCT00229619September 200519 October 2017Rituximab to Treat Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan AnemiaA Pilot Study of Recombinant Humanized Anti- Cluster of Differentiation Antigen 20 (Anti-CD20) Antibody (Rituximab) in Patients With Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan AnemiaAnemia, Aplastic;Red-Cell Aplasia, Pure;Anemia, Diamond-BlackfanDrug: RituximabNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting2 YearsN/AAll11Phase 2United States
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146NCT00676806July 200516 December 2017A Phase II Study of Umbilical Cord Blood TransplantationA Phase II Study of Umbilical Cord Blood Transplantation Following Myeloablative or Reduced-Intensity ConditioningLeukemia;Lymphoma;Multiple Myeloma;Aplastic AnemiaBiological: Umbilical Cord Blood After Myeloablative Conditioning;Biological: Umbilical Cord Blood After Reduced-Intensity ConditioningTufts Medical CenterNot recruitingN/A70 YearsAll7Phase 2United States
147NCT00295997May 200519 February 2015Donor 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)Not recruitingN/A74 YearsBoth35N/AUnited States
148NCT00806598May 200519 October 2017Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic SyndromePhase II Study of Combination of Thymoglobulin, Cyclosporine, Methylprednisone, and Granulocyte Colony-stimulating Factor (GCSF) in Patients With Newly Diagnosed Aplastic Anemia or With Hypoplastic or Low/Intermediate-1 Risk Myelodysplastic SyndromeMyelodysplastic Syndrome;Aplastic AnemiaDrug: Thymoglobulin;Drug: Cyclosporine;Drug: Methylprednisolone;Drug: G-CSFM.D. Anderson Cancer CenterGenzyme, a Sanofi CompanyNot recruiting15 YearsN/AAll53Phase 2United States
149NCT01231841March 200519 October 2017Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic AnemiaProtocol for Prospective Phase II Study of Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin) and Cyclosporine (CsA) as a First Line Immunosuppressive (IS) Therapy for Severe Aplastic Anemia (sAA)Aplastic AnemiaDrug: cyclosporine;Other: flow cytometry;Biological: anti-thymocyte globulinThe Cleveland ClinicNot recruiting12 YearsN/AAll20Phase 2United States
150EUCTR2004-004914-18-IT21/01/20057 January 2013A pilot multicentric study for the use of the anti-TNF alfa in patients with: 1) Fanconi Anemia with marrow failure with no bone marrow compatible donor 2) In patients with acquired aplastic anemia failing immunosuppression and with no bone marrow donorA pilot multicentric study for the use of the anti-TNF alfa in patients with: 1) Fanconi Anemia with marrow failure with no bone marrow compatible donor 2) In patients with acquired aplastic anemia failing immunosuppression and with no bone marrow donorMarrow failure in patients refractary/non eligible to conventional treatments;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Trade Name: ENBREL*SC 4FL 25MG+4SIR 1ML
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Etanercept
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration number: .4-
ISTITUTO GIANNINA GASLINIAuthorisedFemale: yes
Male: yes
Italy
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151JPRN-C0000003562004/12/012 April 2019Evaluation of the safety and efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) using alemtuzumab for patients with aplastic anemiaAplastic anemiaAlemtuzumab is added to the fludarabine-based regimen at 0.16 – 0.25 mg/kg per day for 6 days (days -10 to -5).GCP-ISS HE0403 groupNot Recruiting20years-old65years-oldMale and Female38Phase 1,2Japan
152NCT00065260July 200319 October 2017Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic AnemiaA Randomized Trial of Immunosuppression in Aplastic Anemia Patients With Refractory Pancytopenia or Suboptimal Hematologic Response After h-ATG/CsA TreatmentAplastic AnemiaDrug: Campath-1H;Drug: r-ATG;Drug: CsANational Heart, Lung, and Blood Institute (NHLBI)Not recruiting2 YearsN/AAll54Phase 2United States
153NCT00061360May 23, 200314 October 2019Improving Immunosuppressive Treatment for Patients With Severe Aplastic AnemiaA Randomized Trial of a Novel Immunosuppressive Combination of ATG, CsA and Sirolimus (Rapamune) vs a Slow Taper Cyclosporine Regimen in Subjects With Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: ATG+Rapamune+cyclosporine;Drug: ATG+cyclosporineNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting2 Years110 YearsAll77Phase 2United States
154NCT00186797December 200219 February 2015Purified 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 HospitalNot recruitingN/A21 YearsBoth28N/AUnited States
155NCT00533923December 20028 August 2016Nonmyeloablative 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 CenterBayerNot recruitingN/A65 YearsBoth25Phase 2United States
No.TrialIDDate_
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156NCT00399971November 200219 February 2015Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic AnemiaPhase I/II Study of An Ex Vivo Immunotherapy for Treatment of Idiopathic Aplastic AnemiaAnemia, AplasticProcedure: Ex Vivo Immunotherapy;Drug: Ex vivo immunotherapyShenzhen Zhongxing Yangfan Biotech Co. Ltd.The 12th Guangzhou Municipal Hospital;Liu Hua Qiao HospitalRecruiting10 Years80 YearsBoth100Phase 1/Phase 2China
157NCT00516152November 200219 February 2015Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCTPhase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell TransplantationChronic Myeloid Leukemia;Acute Myelogenous Leukemia;Myelodysplasia;Acute Lymphocytic Leukemia;Severe Aplastic Anemia;Non-Hodgkin's Lymphoma;Lymphoproliferative Disease;Multiple Myeloma;Advanced Myeloproliferative DiseaseDrug: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSFUniversity of California, San FranciscoNot recruiting15 Years61 YearsBoth36Phase 2United States
158NCT00053157June 200219 February 2015Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic AnemiaUse Of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) To Mobilize Donor Peripheral Blood Stem Cells Along With GM-CSF Administration Post Allogeneic Transplant - A Pilot StudyChronic Myeloproliferative Disorders;Graft Versus Host Disease;Leukemia;Lymphoma;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative NeoplasmsBiological: sargramostimRoswell Park Cancer InstituteNational Cancer Institute (NCI)Not recruiting5 Years60 YearsBoth10N/AUnited States
159NCT00054236May 200219 February 2015Combination 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 CenterNational Cancer Institute (NCI)Not recruitingN/AN/ABoth55Phase 1United States
160NCT00578903February 200219 October 2017Allogeneic Stem Cell Transplant for Patients With Severe Aplastic AnemiaAllogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related Donors (SAA MUD)Aplastic AnemiaDrug: Cytoxan;Drug: Campath;Radiation: Total Body Irradiation (TBI);Drug: FK-506;Drug: Methotrexate;Procedure: Stem cell infusionBaylor College of MedicineThe Methodist Hospital System;Texas Children's Hospital;Center for Cell and Gene Therapy, Baylor College of MedicineNot recruitingN/A60 YearsAll22Phase 2United States
No.TrialIDDate_
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161NCT00053989January 29, 200217 September 2018Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer or Aplastic AnemiaNon-Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Aplastic AnemiaChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative DiseasesBiological: 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 transplantation;Biological: anti-thymocyte globulinRoswell Park Cancer InstituteNot recruiting5 Years75 YearsAll41Phase 2United States
162NCT00590460July 200111 June 2018Antibody Conditioning Regimen For Allogeneic Donor Stem Cell Transplantation Of Patients With Fanconi AnemiaCd45 (Yth-24 and Yth 54) and Cd52 (Campath-1H) Monoclonal Antibody Conditioning Regimen for Allogeneic Donor Stem Cell Transplantation of Patients With Fanconi AnemiaFanconi Anemia;Severe Aplastic AnemiaBiological: CAMPATH-1H;Biological: Anti-CD45;Drug: Fludarabine;Procedure: Stem cell infusionBaylor College of MedicineTexas Children's Hospital;The Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of MedicineNot recruitingN/AN/AAll5Phase 1/Phase 2United States
163NCT00017654April 200119 February 2015Study 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 HospitalNot recruiting15 Years55 YearsBoth3N/AUnited States
164NCT01163942March 200113 April 2015Randomized Study In Severe Aplastic Anemia Patients Receiving Atg, Cyclosporin A, With Or Without G-CSF (SAA-G-CSF)A RANDOMIZED CONTROLLED STUDY IN NEWLY DIAGNOSED SEVERE APLASTIC ANEMIA PATIENTS RECEIVING ANTITHYMOCYTE GLOBULIN (ATG), CYCLOSPORIN A, WITH OR WITHOUT G-CSFAplastic AnaemiaDrug: G-CSF;Drug: Early retreatment with ATGEuropean Group for Blood and Marrow TransplantationCHUGAI sanofi-aventisNot recruitingN/AN/ABoth205Phase 3Czech Republic;France;Germany;Greece;Italy;Netherlands;Sweden;Switzerland;United Kingdom
165NCT00011830February 200119 February 2015Stem Cell Mobilization Potential in Patients With Aplastic Anemia in RemissionA Pilot Study of G-CSF Induced Stem Cell Mobilization Potential in Patients With Relapsed Severe Aplastic AnemiaAplastic AnemiaDrug: G-CSF;Procedure: ApheresisNational Heart, Lung, and Blood Institute (NHLBI)Not recruitingN/AN/ABoth20Phase 1United States
No.TrialIDDate_
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166NCT00427336December 200019 October 2017Purine 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 CenterNot recruitingN/A70 YearsAll9N/AUnited States
167NCT00005935June 200019 February 2015Mycophenolate Mofetil and Cyclosporine to Treat Relapsing Aplastic AnemiaA Randomized Trial for the Treatment of Relapsing Aplastic Anemia With Mycophenolate Mofetil (MMF) and Cyclosporine (CSA)Aplastic AnemiaDrug: Mycophenolate mofetil;Drug: CyclosporineNational Heart, Lung, and Blood Institute (NHLBI)Not recruitingN/AN/ABoth130Phase 2United States
168NCT00006379June 200019 February 2015Non-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)Not recruitingN/A70 YearsBoth58Phase 2United States
169NCT01499147February 200016 December 2017Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic MalignanciesFludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic MalignanciesAcute Myeloid Leukemia;Acute Leukemia;Chronic Myelogenous Leukemia;Malignant Lymphoma;Hodgkin's Disease;Multiple Myeloma;Lymphocytic Leukemia;Myeloproliferative Disorder;Polycythemia Vera;Myelofibrosis;Aplastic AnemiaDrug: fludarabine/busulfan;Drug: fludarabine/ melphalan;Drug: ATGUniversity of Illinois at ChicagoNot recruiting10 Years65 YearsAll100N/AUnited States
170NCT00001964December 2, 19994 November 2019Combination Therapy of Severe Aplastic AnemiaTreatment of Severe Aplastic Anemia With Combined Immunosuppression: Antithymocyte Globulin (ATG) and Cyclosporine A (CSA), and Mycophenolate Mofetil (MMF)Severe Aplastic AnemiaDrug: Cyclosporine A;Drug: ATG;Drug: MMFNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting1 Year99 YearsAll104Phase 2United States
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171NCT00001962November 199919 October 2017A Study to Determine Whether Therapy With Daclizumab Will Benefit Patients With Bone Marrow FailureA Pilot Study of Recombinant Humanized Anti-Interleukin (IL-2) Receptor Antibody (Daclizumab) in Patients With Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan AnemiaAplastic Anemia;Pure Red Cell Aplasia;Diamond Blackfan AnemiaDrug: DaclizumabNeal Young, M.D.Not recruiting2 YearsN/AAll100Phase 2United States
172NCT00004143September 199919 October 2017Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure SyndromesAllogeneic Mixed Chimerism Stem Cell Transplantation Utilizing In Vivo and In Vitro Campath for Hemoglobinopathies and Bone Marrow Failure SyndromesSickle Cell Anemia;Severe Aplastic Anemia;Paroxysmal Nocturnal Hemoglobinuria (PNH);Pure Red Cell AplasiaDrug: Campath, Chemo and/or TBI Allo SCTDavid Rizzieri, MDNot recruiting18 YearsN/AAll2Phase 2United States
173NCT00636909July 199916 December 2017Nonmyeloablative 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 CenterAmgenNot recruitingN/A65 YearsAll25Phase 2
174NCT00003816October 19, 199830 September 2019Combination 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 InstituteNot recruiting4 Years70 YearsAll362Phase 2/Phase 3United States
175NCT00004474September 199811 June 2018Phase 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 InstituteNot recruitingN/A59 YearsAll224Phase 3United States
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176NCT00003336January 199819 February 2015Pilot 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)Not recruitingN/A55 YearsBoth6Phase 2United States
177NCT00001626June 2, 19977 October 2019Comparing 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)Not recruiting15 Years110 YearsAll33Phase 2United States
178NCT00005852June 199619 February 2015Bone 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)Not recruiting15 Years55 YearsBothPhase 2
179NCT00004464February 199628 January 2019Study 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 HopkinsNot recruitingN/A70 YearsAll69Phase 2United States
180NCT00002718November 19954 January 2016T-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)Not recruitingN/A49 YearsBoth31Phase 2United States
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181NCT00004323February 199519 February 2015Phase 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 AngelesNot recruitingN/A55 YearsBoth10Phase 2United States
182NCT00001398October 199319 February 2015Stem Cell Factor Medication for Aplastic AnemiaA Phase I/II Trial of Recombinant Methionyl Human Stem Cell Factor (r-metHuSCF) in Patients Diagnosed With Acquired Aplastic AnemiaAplastic Anemia;PancytopeniaDrug: Recombinant Methionyl Human Stem Cell Factor (r-metHuSCF)National Heart, Lung, and Blood Institute (NHLBI)Not recruitingN/AN/ABoth40Phase 1United States
183NCT00212407February 199312 November 2018New York Blood Center National Cord Blood ProgramNew York Blood Center National Cord Blood ProgramLeukemia;Lymphoma;Genetic Disease;Severe Aplastic Anemia;MyelodysplasiaBiological: Umbilical Cord Blood TransplantationNew York Blood CenterNot recruitingN/AN/AAll4476Early Phase 1United States
184NCT00000597March 198219 February 2015Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic DisordersAnemia, Aplastic;Hematologic Diseases;Pancytopenia;Blood DiseaseDrug: antilymphocyte serum;Drug: nandroloneNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting18 Years75 YearsBothPhase 3

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