60. 再生不良性貧血 Aplastic anemia Clinical trials / Disease details


臨床試験数 : 235 薬物数 : 381 - (DrugBank : 83) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 160

  
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT05031897
(ClinicalTrials.gov)
October 25, 202131/8/2021Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell TransplantA 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity ConditioningAcute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Aplastic Anemia;Chronic Lymphocytic Leukemia;Chronic Myelomonocytic Leukemia;Essential Thrombocythemia;Hematopoietic and Lymphoid Cell Neoplasm;Hodgkin Lymphoma;Myelodysplastic Syndromes;Myelofibrosis;Myeloid Leukemia;Myeloid Neoplasm;Non-Hodgkin Lymphoma;Plasma Cell Myeloma;Polycythemia Vera;Small Lymphocytic LymphomaProcedure: Hematopoietic Cell Transplantation;Drug: Mycophenolate Mofetil;Drug: Tacrolimus;Drug: Cyclophosphamide;Radiation: Total-Body Irradiation;Procedure: Donor Lymphocyte Infusion;Drug: Fludarabine;Drug: MelphalanThomas Jefferson UniversityNULLRecruiting18 YearsN/AAll67Phase 2United States
2NCT05018936
(ClinicalTrials.gov)
October 1, 202119/8/2021Efficacy and Safety of Hetrombopag in Non-severe Aplastic AnemiaEfficacy and Safety of Hetrombopag in Non-severe Aplastic Anemia: a Prospective Single Arm StudyAplastic Anemia;Drug EffectDrug: HetrombopagPeking Union Medical College HospitalNULLNot yet recruiting18 Years75 YearsAll40Phase 2/Phase 3China
3NCT05049668
(ClinicalTrials.gov)
October 202113/9/2021RACE 2: a Long Term Follow-up of Patients Participating in the RACE TrialLong-term Follow-up of Patients Participating in RACE: the Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia PatientsSevere Aplastic AnemiaDrug: ATGAM plus CsA with or without EltrombopagEuropean Society for Blood and Marrow TransplantationNULLEnrolling by invitationN/AN/AAll197France
4NCT05088655
(ClinicalTrials.gov)
June 25, 202112/10/2021A Bioequivalence Study of Hetrombopag in Healthy SubjectsBioequivalence Study of Different Formulations of Hetrombopag Olamine Tablets in Healthy SubjectsSever Aplastic AnaemiaDrug: Hetrombopag Olamine TabletJiangsu HengRui Medicine Co., Ltd.NULLRecruiting18 Years45 YearsAll57Phase 1China
5ChiCTR2100045322
2021-06-012021-04-12Efficacy and safety of umbilical cord mesenchymal stem cells combined with standard immunosuppressive agents in the treatment of children with acquired severe aplastic anemia: a randomized, controlled clinical studyEfficacy and safety of umbilical cord mesenchymal stem cells combined with standard immunosuppressive agents in the treatment of children with acquired severe aplastic anemia: a randomized, controlled clinical study pediatric acquired severe aplastic anemiaExperimental group:Anti-thymocyte globulin+Ciclosporin A+Mesenchymal stem cell;Control group:Anti-thymocyte globulin+Ciclosporin A;Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical SciencesNULLRecruiting116BothExperimental group:32;Control group:32;China
6ChiCTR2100047288
2021-06-012021-06-11Efficacy and safety of combined immunosuppressive therapy plus umbilical cord blood infusion in myelodysplastic syndromes/aplastic anemia patients: a clinical observation studyEfficacy and safety of combined immunosuppressive therapy plus umbilical cord blood infusion in myelodysplastic syndromes/aplastic anemia patients: a clinical observation study myelodysplastic syndromes/aplastic anemiExperimental group1:According to the classification, ATG + CsA/CSA alone is used as the pretreatment plan/supportive treatment + non-blood cord blood stem cell infusion treatment;Experimental group2:Decitabine+cytarabine/decitabine alone is used as the pretreatment plan/supportive treatment+non-blood cord blood stem cell infusion treatment according to the classification;The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)NULLRecruiting1890BothExperimental group1:10;Experimental group2:10;China
7NCT04854889
(ClinicalTrials.gov)
April 22, 202114/4/2021Efficacy and Safety of Low-dose Decitabine in Refractory Aplastic AnemiaEfficacy and Safety of Low-dose Decitabine in Refractory Aplastic Anemia (LODACA): a Phase 2, Single-arm, Open-label StudyRefractory Aplastic AnemiaDrug: DecitabineInstitute of Hematology & Blood Diseases HospitalNULLRecruiting12 YearsN/AAll45Phase 2China
8ChiCTR2100043229
2021-02-222021-02-09A Single-Center, Single-Arm, Phase II Clinical Study of the Efficacy and Safety of Cyclosporine Combined with Eltrombopag Olamine Tablets in Treatment-Naive Transfusion-Dependent Non-Severe Aplastic AnemiaA Single-Center, Single-Arm, Phase II Clinical Study of the Efficacy and Safety of Cyclosporine Combined with Eltrombopag Olamine Tablets in Treatment-Naive Transfusion-Dependent Non-Severe Aplastic Anemia Aplastic anemiaDurgs Group:Elrombopag combined with Cyclosporine;Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesNULLRecruiting1885BothDurgs Group:61;Phase 2China
9NCT04728789
(ClinicalTrials.gov)
February 1, 20211/12/2020Avatrombopag Usage in NSAAEfficacy and Safety of Avatrombopag in Non-severe Aplastic Anemia - a Multicenter Prospective Single Arm StudyAplastic Anemia;Drug EffectDrug: Avatrombopag 20 MGPeking Union Medical College HospitalNULLNot yet recruiting18 Years75 YearsAll40Phase 2/Phase 3China
10NCT04558736
(ClinicalTrials.gov)
January 21, 20219/9/2020Haploidentical HCT for Severe Aplastic AnemiaHaploidentical Donor Hematopoietic Cell Transplantation for Patients With Severe Aplastic AnemiaAplastic Anemia;Bone Marrow Failure SyndromeDrug: Anti-Thymocyte Globulin (Rabbit);Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: G-CSF;Radiation: Total Lymphoid Irradiation (TLI);Device: CliniMACS;Biological: HPC, A Infusion;Biological: CD45RA-depleted DLISt. Jude Children's Research HospitalNULLRecruitingN/A21 YearsAll21Phase 2United States
11NCT04409080
(ClinicalTrials.gov)
January 13, 202126/5/2020REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive TherapyA Phase 1/2 Study of REGN7257 (Anti-Interleukin 2 Receptor Subunit Gamma [IL2RG] Monoclonal Antibody) in Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive TherapySevere Aplastic Anemia (SAA)Drug: REGN7257Regeneron PharmaceuticalsNULLRecruiting18 YearsN/AAll48Phase 1/Phase 2United States;France;Korea, Republic of;United Kingdom
12ChiCTR2000041485
2021-01-012020-12-27Efficacy of Danazol after no response to cyclosporin in transfusion independent aplastic anemia: a prospective studyEfficacy of Danazol after no response to cyclosporin in transfusion independent aplastic anemia: a prospective study transfusion independent aplastic anemiaexperimental group:Cyclosporine combined with danazol;control group:Cyclosporine;Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union Medical CollegeNULLRecruitingBothexperimental group:152;control group:76;Phase 4China
13EUCTR2020-002031-29-FR
(EUCTR)
21/12/202010/07/2020REGN7257 in Adult Patients with Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive TherapyA PHASE 1/2 STUDY OF REGN7257 (ANTI-INTERLEUKIN 2 RECEPTOR SUBUNIT GAMMA [IL2RG] MONOCLONAL ANTIBODY) IN PATIENTS WITH SEVERE APLASTIC ANEMIA THAT IS REFRACTORY TO OR RELAPSED ON IMMUNOSUPPRESSIVE THERAPY SEVERE APLASTIC ANEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10002274;Term: Anemia aplastic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: REGN7257
INN or Proposed INN: Not Applicable
Other descriptive name: HUMAN IGG4 ISOTYPE MONOCLONAL (IL2-RG) ANTIBODY
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 1;Phase 2United States;France;United Kingdom;Korea, Republic of
14EUCTR2020-002031-29-GB
(EUCTR)
05/11/202030/06/2020REGN7257 in Adult Patients with Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive TherapyA PHASE 1/2 STUDY OF REGN7257 (ANTI-INTERLEUKIN 2 RECEPTOR SUBUNIT GAMMA [IL2RG] MONOCLONAL ANTIBODY) IN PATIENTS WITH SEVERE APLASTIC ANEMIA THAT IS REFRACTORY TO OR RELAPSED ON IMMUNOSUPPRESSIVE THERAPY SEVERE APLASTIC ANEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10002274;Term: Anemia aplastic;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: REGN7257
INN or Proposed INN: Not Applicable
Other descriptive name: HUMAN IGG4 ISOTYPE MONOCLONAL (IL2-RG) ANTIBODY
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 1;Phase 2United States;France;United Kingdom;Korea, Republic of
15NCT04328727
(ClinicalTrials.gov)
November 4, 20209/3/2020Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic AnemiaA Non-randomized, Open Label, Multi-center, Phase II Study to Assess the Safety and Efficacy of Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin (r-ATG) and Cyclosporine A (CsA) in East-Asian Patients With Treatment Naive Severe Aplastic Anemia (REACTS)Severe Aplastic Anemia (SAA)Drug: eltrombopag;Drug: rabbit anti-thymocyte globulin (r-ATG);Drug: cyclosporine A (CsA)Novartis PharmaceuticalsNULLActive, not recruiting6 YearsN/AAll36Phase 2China;Japan;Korea, Republic of;Taiwan
16ChiCTR2100045895
2020-11-012021-04-27Clinical database registration of aplastic anemia patientsClinical database registration of aplastic anemia patients aplastic anemiaNon-transfusions independent non-severe aplastic anemia:ciclosporin;Transfusion dependent non - severe aplastic anemia:CsA combined with hematopoietic therapy;Severe aplastic anemia:Intensive immunosuppressive therapy;Severe aplastic anemia:Hematopoietic stem cell transplantation;Non-transfusions independent non-severe aplastic anemia:Promoting hematopoiesis therapy;Jiangsu Province HospitalNULLRecruiting1875BothNon-transfusions independent non-severe aplastic anemia:100;Transfusion dependent non - severe aplastic anemia:50;Severe aplastic anemia:100;Severe aplastic anemia:100;Non-transfusions independent non-severe aplastic anemia:100;Phase 4China
17NCT04439006
(ClinicalTrials.gov)
October 23, 202017/6/2020Ibrutinib for the Treatment of COVID-19 in Patients Requiring HospitalizationRandomized Double-Blind Phase 2 Trial of Ibrutinib Versus Standard Treatment for COVID-19 Illness Requiring Hospitalization With Safety Lead-InAplastic Anemia;Hematopoietic and Lymphoid Cell Neoplasm;Malignant Solid Neoplasm;Monoclonal B-Cell Lymphocytosis;Monoclonal Gammopathy of Undetermined Significance;Myelodysplastic Syndrome;Symptomatic COVID-19 Infection Laboratory-ConfirmedOther: Best Practice;Drug: IbrutinibJennifer WoyachJanssen Scientific Affairs, LLCActive, not recruiting18 YearsN/AAll10Phase 2United States
18NCT05088642
(ClinicalTrials.gov)
September 28, 202012/10/2021A Trial of Hetrombopag in Healthy and Hepatic Impairment SubjectsA Phase I Clinical Study Evaluating the Pharmacokinetics and Safety of Hetrombopag Olamine Tablets in Subjects With Mild Hepatic Impairment (Child-Pugh Class A), Moderate Hepatic Impairment (Child-Pugh Class B), and Normal Hepatic FunctionSever Aplastic AnaemiaDrug: Hetrombopag Olamine TabletJiangsu HengRui Medicine Co., Ltd.NULLCompleted18 Years65 YearsAll24Phase 1China
19NCT05088174
(ClinicalTrials.gov)
September 3, 202012/10/2021A Trial of Hetrombopag in Healthy SubjectsA Single-Center, Single-Arm, Open-Label, Self-Controlled, Drug-Drug Interaction Study of Hetrombopag Olamine and Ciclosporin in Healthy SubjectsSever Aplastic AnaemiaDrug: Hetrombopag Olamine Tablet;Ciclosporin Soft CapsuleJiangsu HengRui Medicine Co., Ltd.NULLCompleted18 Years65 YearsAll26Phase 1China
20NCT04478227
(ClinicalTrials.gov)
August 18, 202010/7/2020TPO-Mimetic Use in Children for Hemotopoietic FailureSingle Arm Prospective Open Label Pilot Study Evaluating Short-Term Safety and Efficacy of Romiplostim in Children With Inherited and Acquired Disorders of Hematopoietic FailureBone Marrow Failure Disorders;Aplastic Anemia;Thrombocytopenia;Refractory Cytopenia of Childhood;Myelodysplastic Syndrome(MDS)Drug: RomiplostimAnjali SharathkumarAmgenRecruitingN/A21 YearsAll25Early Phase 1United States
21NCT04350606
(ClinicalTrials.gov)
July 25, 20201/4/2020A Study to Assess Efficacy and Safety of PF-06462700 in Japanese Participants With Aplastic AnemiaA MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06462700 ADMINISTERED INTRAVENOUSLY AT 40 MG/KG/DAY FOR 4 DAYS IN JAPANESE PARTICIPANTS WITH MODERATE AND ABOVE APLASTIC ANEMIAAplastic AnemiaBiological: PF-06462700PfizerNULLCompleted2 YearsN/AAll3Phase 3Japan
22NCT04356469
(ClinicalTrials.gov)
July 22, 202019/4/2020TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Non-Malignant Hematological Disorders in ChildrenStudy of TCR Alpha Beta T-Cell and CD19 B-Cell Depletion for Hematopoietic Cell Transplantation From Haploidentical Donors in the Treatment of Non-Malignant Hematological Disorders in ChildrenHemoglobinopathy (Disorder);Severe Aplastic Anemia;Bone Marrow Failure SyndromeBiological: Haploidentical Hematopoietic Cell TransplantationJohns Hopkins All Children's HospitalNULLRecruitingN/A21 YearsAll17Phase 2United States
23NCT04403321
(ClinicalTrials.gov)
July 1, 202021/5/2020Efficacy and Safety of Eltrombopag + Tacrolimus/Cyclosporin A in Chinese Refractory or Relapsed Aplastic Anemia PatientsEfficacy and Safety of Eltrombopag + Tacrolimus/Cyclosporin A in Chinese Refractory or Relapsed Aplastic Anemia PatientsAplastic Anemia;Drug EffectDrug: Tacrolimus;Drug: Placebo (for Tacrolimus);Drug: Cyclosporin APeking Union Medical College HospitalNULLNot yet recruiting16 Years80 YearsAll60Phase 2China
24NCT04304820
(ClinicalTrials.gov)
May 7, 202010/3/2020Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA)Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA)Severe Aplastic AnemiaDrug: Eltrombopag;Drug: Cyclosporine;Drug: Horse-Anti-thymocyte-GlobulinNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting3 YearsN/AAll39Phase 2United States
25ChiCTR2000031933
2020-04-142020-04-15Foscarnet sodium for the treatment of pure erythrocyte aplastic anemia due to parvovirus B19 infection after kidney transplantation:study protocol for a prospective single-center trialFoscarnet sodium for the treatment of pure erythrocyte aplastic anemia due to parvovirus B19 infection after kidney transplantation:study protocol for a prospective single-center trial Pure red blood cell aplastic anemia after kidney transplantcase series:Foscarnet ( IV.);The First Affiliated Hospital of Zhejiang University School of MedicineNULLPendingBothcase series:20;China
26NCT04099966
(ClinicalTrials.gov)
April 1, 202018/9/2019AlloSCT 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 CairoNULLNot yet recruitingN/A30 YearsAll20Phase 2United States
27ChiCTR2000028833
2020-01-012020-01-05Superiority of a metformin hydrochloride combination regimen for aplastic anemia in a phase II clinical trialSuperiority of a metformin hydrochloride combination regimen for aplastic anemia in a phase II clinical trial Acquired aplastic anemia;3A70.1Experimental group:Combined regimen with metformin hydrochloride;Control group:HSCT/ATG;Department of Hematology, Second Medical Center, Chinese PLA General HospitalNULLPending14MaleExperimental group:47;Control group:47;Phase 2China
28NCT03988608
(ClinicalTrials.gov)
December 9, 201913/6/2019Study 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 PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll20Phase 2China
29NCT04095936
(ClinicalTrials.gov)
December 3, 201918/9/2019Study 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.NULLActive, not recruiting20 YearsN/AAll24Phase 2/Phase 3Japan
30JPRN-JapicCTI-194962
03/12/201918/09/2019A 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 Therapy Aplastic 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., LtdNULLcomplete20BOTH24Phase 2-3Japan, Asia except Japan
31ChiCTR1900027553
2019-11-282019-11-18Clinical therapies for patients in subtypes of non-severe aplastic anemiaClinical therapies for patients in subtypes of non-severe aplastic anemia non-severe aplastic anemiaearly NSAA:Cyclosporine;moderate NSAA1:Cyclosporine;moderate NSAA2:Cyclosporine+Danazol;TD NSAA:CSA+TPO+G-CSF;Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical SciencesNULLPending1885Bothearly NSAA:89;moderate NSAA1:37;moderate NSAA2:39;TD NSAA:325;China
32JPRN-jRCTs071190032
26/11/201921/10/2019W-JHS AA02Investigation on the effectiveness of rabbit ATG + cyclosporine + eltrombopag therapy for patients with aplastic anemia - W-JHS AA02 aplastic 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).
Ishiyama KenNULLRecruiting>= 18age old< 80age oldBoth60Phase 2Japan
33NCT03896971
(ClinicalTrials.gov)
November 15, 201921/3/2019Combination 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 UniversityCompleted16 Years65 YearsAll66Phase 4Egypt
34NCT03836690
(ClinicalTrials.gov)
October 21, 201910/1/2019Transfer 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
35NCT04961710
(ClinicalTrials.gov)
September 19, 201912/7/2021Extension Study of Hetrombopag in Severe Aplastic AnemiaExtension Study of Hetrombopag Olamine in Patients With Treatment-naive Severe Aplastic AnemiaTreatment-naive Severe Aplastic AnemiaDrug: Hetrombopag Olamine;Drug: PlaceboJiangsu HengRui Medicine Co., Ltd.NULLRecruiting15 Years75 YearsAll180Phase 3China
36ChiCTR1900026462
2019-08-192019-10-11Clinical study for umbilical cord blood mesenchymal stem cells combined with peripheral blood stem cells co-transplantation with reduced PT-Cy in the prevention of GVHD in the treatment of aplastic anemiaClinical study for umbilical cord blood mesenchymal stem cells combined with peripheral blood stem cell co-transplantation with reduced PT-Cy in the prevention of GVHD in the treatment of aplastic anemia--single-center, single-arm, open clinical study aplastic anemia,AACass series:low dose post Cyclophosphamide and Mesenchymal stem cell;Cancer Hospital Affiliated to Zhengzhou University-He'nan Cancer HospitalNULLRecruitingBothCass series:20;China
37NCT03622788
(ClinicalTrials.gov)
August 8, 20193/8/2018Cytokine-Treated Veto Cells in Treating Patients With Hematologic Malignancies Following Stem Cell TransplantAnti-Viral Central Memory CD8 Veto Cells in Haploidentical Hematopoietic Stem Cell TransplantationAcute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Aplastic Anemia;Bone Marrow Failure;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Follicular Lymphoma;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 Years75 YearsAll24Phase 1/Phase 2United States
38EUCTR2016-002814-29-IT
(EUCTR)
14/06/201924/05/2021SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemiaSOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR First-line severe aplastic anaemia
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: SANDIMMUN NEORAL - 10 MG CAPSULE MOLLI 50 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral ]
INN or Proposed INN: 00070500
Other descriptive name: CICLOSPORINA
Trade Name: SANDIMMUN NEORAL - 25 MG CAPSULE MOLLI 50 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral]
INN or Proposed INN: 00070500
Other descriptive name: CICLOSPORINA
Trade Name: SANDIMMUN NEORAL - 50 MG CAPSULE MOLLI 50 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral]
INN or Proposed INN: 00070500
Trade Name: SANDIMMUN NEORAL - 100 MG CAPSULE MOLLI 30 CAPSULE
Product Name: Sandimmun Neoral
Product Code: [Sandimmun Neoral]
INN or Proposed INN: 00070500
Trade Name: REVOLADE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU) 28 COMPRESSE
Product Name: Eltrombopag
Product Code: [ETB115]
INN or Proposed INN: 00319301
Other descriptive name: Eltrombopag
Trade Name: REVOLADE - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER(PA/ALU/PVC/ALU
NOVARTIS PHARMA AGNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Hungary;Hong Kong;Mexico;Spain;Thailand;Brazil;Korea, Democratic People's Republic of;Turkey;Netherlands;Italy;India
39NCT03906318
(ClinicalTrials.gov)
June 4, 20194/4/2019Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic AnemiaNULLDrug: ItacitinibIncyte CorporationNULLAvailableN/AN/AAllNULL
40EUCTR2015-003166-91-GB
(EUCTR)
22/05/201905/07/2017A phase II dose escalation study: use of eltrombopag in pediatric patientswith 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
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Portugal;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom
41NCT03957694
(ClinicalTrials.gov)
April 25, 20199/5/2019Study 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.NULLActive, not recruiting20 YearsN/AAll14Phase 2/Phase 3Japan
42NCT03825744
(ClinicalTrials.gov)
March 5, 201930/1/2019Hetrombopag 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.NULLRecruiting15 Years75 YearsAll180Phase 3China
43NCT03520647
(ClinicalTrials.gov)
February 19, 20199/5/2018Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD ProphylaxisHaplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD ProphylaxisSevere Aplastic Anemia (SAA);Hypo-Plastic Myelodysplastic Syndrome (MDS);Paroxysmal Nocturnal Hemoglobinuria (PNH)Drug: Cyclophosphamide;Other: Peripheral Blood Stem CellsNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting4 Years75 YearsAll56Phase 2United States
44JPRN-JapicCTI-194746
01/2/201909/05/2019A 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 Therapy Aplastic 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., LtdNULLcomplete20BOTH14Phase 2-3Japan, Asia except Japan
45NCT03295058
(ClinicalTrials.gov)
January 1, 201924/9/2017Peripheral 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 UniversityNULLUnknown status16 Years50 YearsAll50Phase 2/Phase 3NULL
46ChiCTR1800019669
2019-01-012018-11-21A randomized, open-label, single-center controlled trial for the efficacy and safety of recombinant human thrombopoietin injection in the treatment of severe Aplastic Anemia with thrombocytopeniaA randomized, open-label, single-center controlled trial for the efficacy and safety of recombinant human thrombopoietin injection in the treatment of severe Aplastic Anemia with thrombocytopenia Aplastic anemia,ThrombocytopeniaGroup 1:Add rhTPO, 300U/kg qd after ATG treatment for 8 weeks;Group 2:Add rhTPO, 300U/kg qod after ATG treatment for 8 weeks;Institute of Hematology, People's Hospital, Peking UniversityNULLPendingBothGroup 1:30;Group 2:30;China
47NCT03821987
(ClinicalTrials.gov)
December 17, 201823/1/2019Risk 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 HospitalNULLRecruiting3 Years55 YearsAll55N/AChina
48EUCTR2015-003166-91-NL
(EUCTR)
14/11/201808/08/2017A 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
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Portugal;United States;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom
49NCT03579875
(ClinicalTrials.gov)
November 13, 201825/5/2018T Cell Receptor a/ß TCD HCT in Patients With Fanconi AnemiaT Cell Receptor Alpha/Beta T Cell Depleted (a/ß TCD) Hematopoietic Cell Transplantation in Patients With Fanconi Anemia (FA)Fanconi Anemia;Severe Aplastic Anemia;Myelodysplastic SyndromesDrug: Total Body Irradiation (TBI) (Plan 1);Drug: Cyclophosphamide (CY) (Plan 1);Drug: Fludarabine (FLU);Drug: Methylprednisolone (MP);Device: Donor mobilized PBSC infusion;Drug: G-CSF;Drug: Cyclophosphamide (CY) (Plan 2);Drug: Rituximab;Drug: BusulfanMasonic Cancer Center, University of MinnesotaNULLRecruitingN/A65 YearsAll48Phase 2United States
50NCT03955601
(ClinicalTrials.gov)
July 12, 201822/4/2019A Novel TBI Free Conditioning Protocol for Haploidentical Transplant in Acquired Aplastic Anemia:A Novel TBI Free Conditioning Protocol for Haploidentical Hematopoeitic Stem Cell Transplant in Acquired Aplastic AnemiaAplastic Anemia IdiopathicDrug: Haploidentical HSCT using TBI free regimen, ''ATG'' with ''Post transplant cyclophosphamide''National Institute of Blood and Marrow Transplant (NIBMT), PakistanNULLRecruiting2 Years60 YearsAll30Phase 2Pakistan
51NCT03557099
(ClinicalTrials.gov)
June 20, 20183/6/2018A Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Severe Aplastic Anemia (SAA) PatientA Multicentre, Open-label, Single-arm, Phase 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.NULLRecruiting18 YearsN/AAll55Phase 1/Phase 2China
52NCT03531736
(ClinicalTrials.gov)
May 9, 20189/5/2018T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic AnemiaAllogeneic Hematopoietic Stem Cell Transplantation of a/ß T-Lymphocyte Depleted Graft Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic AnemiaMyeloid DiseasesDrug: Antithymocyte globulin (Rabbit);Drug: fludarabine;Radiation: total body irradiation;Drug: cyclophosphamide;Drug: Rituxan;Procedure: Allogeneic Hematopoietic Stem Cell TransplantationMemorial Sloan Kettering Cancer CenterNULLRecruiting18 YearsN/AAll15Phase 1United States
53NCT03318159
(ClinicalTrials.gov)
April 20, 201810/10/2017Posaconazole 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.Unknown status18 Years75 YearsAll40Phase 2Korea, Republic of
54NCT03218657
(ClinicalTrials.gov)
January 1, 201816/6/2017Clinical 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 LinNULLRecruiting18 Years70 YearsAll248N/AChina
55NCT03243656
(ClinicalTrials.gov)
December 20, 20172/8/2017Eltrombopag & Cyclosporine in Children With Sever Aplastic AnemiaRandomized Clinical Trial of the Use of & Cyclosporine in Children With Sever Idiopathic Aplastic AnemiaEltrombopagDrug: EltrombopagAssiut UniversityNULLCompleted1 Year18 YearsAll20Phase 4Egypt
56JPRN-UMIN000030453
2017/12/2018/12/2017Efficacy 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 KyushuNULLComplete: follow-up continuing16years-oldNot applicableMale and Female33Not selectedJapan
57EUCTR2015-003166-91-PT
(EUCTR)
15/12/201713/07/2017A phase II dose-escalation study characterizing the PK of eltrombopag in pediatric patients with previously untreated or relapsed severe aplastic anemia or recurrent aplastic anemia.A 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
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Portugal;Hong Kong;Thailand;Russian Federation;Netherlands;United Kingdom
58NCT03333486
(ClinicalTrials.gov)
December 7, 20172/11/2017Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood CancerA Phase II Trial of Haploidentical Allogeneic Stem Cell Transplantation Utilizing Mobilized Peripheral Blood Stem CellsAccelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Acute Leukemia in Remission;Acute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Acute Myeloid Leukemia With FLT3/ITD Mutation;Acute Myeloid Leukemia With Gene Mutations;Aplastic Anemia;B-Cell Non-Hodgkin Lymphoma;CD40 Ligand Deficiency;Chronic Granulomatous Disease;Chronic Leukemia in Remission;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Congenital Amegakaryocytic Thrombocytopenia;Congenital Neutropenia;Congenital Pure Red Cell Aplasia;Glanzmann Thrombasthenia;Immunodeficiency Syndrome;Myelodysplastic Syndrome;Myelofibrosis;Myeloproliferative Neoplasm;Paroxysmal Nocturnal Hemoglobinuria;Plasma Cell Myeloma;Polycythemia Vera;Recurrent Non-Hodgkin Lymphoma;Refractory Non-Hodgkin Lymphoma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndrome;Severe Aplastic Anemia;Shwachman-Diamond Syndrome;Sickle Cell Disease;T-Cell Non-Hodgkin Lymphoma;Thalassemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich SyndromeDrug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Procedure: Peripheral Blood Stem Cell Transplantation;Radiation: Total-Body IrradiationRoswell Park Cancer InstituteNULLRecruiting1 Year75 YearsAll58Phase 2United States
59NCT03176849
(ClinicalTrials.gov)
November 1, 201726/5/2017A 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 HospitalNULLCompleted1 Year25 YearsAll49Phase 4United States
60ChiCTR-IOR-17012957
2017-10-312017-10-12A single Central, open, parallel control study to evaluate the safety and effectiveness of Arsenious Acid- Immunological preparationsand Immunological preparations in aplastic anemia (AA)A single Central, open, parallel control study to evaluate the safety and effectiveness of Arsenious Acid- Immunological preparationsand Immunological preparations in aplastic anemia (AA) aplastic anemiaA:ATO+CsA;B:CsA;Henan Province Cancer HospitalNULLPending1865BothA:100;B:100;China
61ChiCTR-ONC-17012896
2017-10-012017-10-07Haploidentical Stem Cell Transplantation with Post-Transplant Cyclophosphamide Combined with Short-Term Methotrexate for Severe Aplastic AnemiaHaploidentical Stem Cell Transplantation with Post-Transplant Cyclophosphamide Combined with Short-Term Methotrexate for Severe Aplastic Anemia:a multicenter, prospective, open-label, single-arm II/III phase study Aplastic AnemiaCase series:Post-Transplant Cyclophosphamide Combined with Short-Term Methotrexate;Xiangya Hosptial of Central South UniversityNULLRecruiting265BothCase series:30;China
62NCT03025698
(ClinicalTrials.gov)
September 30, 201712/1/2017A 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 PharmaceuticalsNULLActive, not recruiting1 Year18 YearsAll51Phase 2United States;Hong Kong;Portugal;Russian Federation;Thailand;United Kingdom;Netherlands
63EUCTR2016-002814-29-HU
(EUCTR)
07/09/201705/07/2017SOAR 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. - SOAR First-line severe aplastic anaemia
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
INN or Proposed INN: ELTROMBOPAG
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
50Phase 2France;Hong Kong;Hungary;Mexico;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India
64NCT03192397
(ClinicalTrials.gov)
August 9, 201716/6/2017Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell TransplantA Phase 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
65EUCTR2016-002814-29-NL
(EUCTR)
21/07/201729/03/2017SOAR Trial: Eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia with follow-up up to 24-months.SOAR, Interventional phase II single-arm study to assess efficacy and safety of eltrombopag combined with cyclosporine as first line therapy in adult patients with severe acquired aplastic anemia - SOAR First-line severe aplastic anaemia
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
INN or Proposed INN: ELTROMBOPAG
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Hungary;Hong Kong;Mexico;Thailand;Spain;Brazil;Turkey;Netherlands;Italy;Korea, Republic of;India
66NCT02918292
(ClinicalTrials.gov)
July 3, 201727/9/2016Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP) (BMT CTN 1502)Severe Aplastic AnemiaDrug: Antithymocyte Globulin (ATG);Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation (TBI);Procedure: Haplo HSCT;Drug: Tacrolimus;Drug: Mycophenolate mofetil (MMF);Drug: G-CSFMedical College of WisconsinNational Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI);Blood and Marrow Transplant Clinical Trials Network;National Marrow Donor ProgramActive, not recruitingN/A75 YearsAll30Phase 2United States
67ChiCTR-IOR-17011653
2017-07-012017-06-14A 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 hydrochloride Aplastic anemiaSA group:none;LSA group:levamisole hydrochloride;The First affiliated Hospital of Zhejiang Chinese Medical UniversityNULLPending1870BothSA group:124;LSA group:124;China
68NCT03173937
(ClinicalTrials.gov)
June 13, 201731/5/2017Unrelated 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, 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)NULLRecruiting4 Years75 YearsAll37Phase 1/Phase 2United States
69EUCTR2014-000584-41-ES
(EUCTR)
08/06/201721/03/2017Phase II extension study of CaspaCIDe T cells (BPX-501) from an HLA-partially matched family donor after negative selection of TCR aß+T cells in pediatric patients affected by hematological disordersPhase II extension study of CaspaCIDe T cells (BPX-501) 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 HSCT Hematological disorders (ALL;AML;Non-Hodgkin lymphoma;Myelodysplasticsyndromes;Congenital immune deficiencies;Severe aplastic anemia;Fanconi anemia; Osteopetrosis;Selected cases of hemoglobinopathies)
MedDRA version: 19.1;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: BPX-501 cells
INN or Proposed INN: rivogenleucleucel
Other descriptive name: BPX-501
Product Name: AP1903
INN or Proposed INN: Rimiducid
Other descriptive name: AP1903
Bellicum Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
175Phase 2Spain;United Kingdom;Italy
70NCT02998645
(ClinicalTrials.gov)
May 11, 20174/11/2016Eltrombopag Combined With Cyclosporine as First Line Therapy in Patients With Severe Acquired Aplastic AnemiaSOAR, Interventional Phase II Single-arm Study to Assess Efficacy and Safety of Eltrombopag Combined With Cyclosporine as First Line Therapy in Adult Patients With Severe Acquired Aplastic AnemiaSevere Aplastic AnemiaDrug: eltrombopag;Drug: CyclosporineNovartis PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll54Phase 2Brazil;Hong Kong;India;Italy;Korea, Republic of;Mexico;Spain;Thailand;Turkey;Hungary;Netherlands
71EUCTR2016-002814-29-ES
(EUCTR)
21/03/201716/12/2016SOAR 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. - SOAR First-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
INN or Proposed INN: ELTROMBOPAG
Trade Name: REVOLADE
Product Name: Eltrombopag
Product Code: ETB115
INN or Proposed INN: ELTROMBOPAG
Novartis Farmacéutica, S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Qatar;Hong Kong;Spain;Turkey;Italy;India;France;Hungary;Mexico;Canada;Brazil;Netherlands;Korea, Republic of
72EUCTR2016-003226-16-IT
(EUCTR)
03/02/201717/11/2016Follow-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 HSCT Hematological disorders (ALL;AML;Non-Hodgkin lymphoma;Myelodysplasticsyndromes;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
Other descriptive name: AP1903
Bellicum Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
175Phase 1;Phase 2Italy
73NCT02838992
(ClinicalTrials.gov)
February 20176/7/2016ATG Combined With Cyclophosphamide And Cord Blood Transfusion in Treating Patients With Severe Aplastic AnemiaMulti-center Clinical Study of Immunosuppressants, Cyclophosphamide, And Cord Blood Transfusion in Treating Patients With Severe Aplastic AnemiaAplastic AnemiaDrug: Rabbit ATG, (Genzyme);Drug: Cy;Drug: CsA;Biological: Cord bloodJinan Military General HospitalShandong University of Traditional Chinese Medicine;Jining Medical University;Affiliated Hospital of Weifang Medical University;Guangzhou First People's Hospital;Harbin Hematology and Oncology Institute;JINING No.1 People's Hospital;JIANGXI Provincal People's Hospital;Jinhua Central Hospital;Linyi People's Hospital;Shandong Cord Blood Bank;Qingdao Center Medical Group;Qingdao University;Taian City Central Hospital;Yantai Yuhuangding Hospital;Yishui Central Hospital of LINYI;Institute of Hematology & Blood Diseases Hospital;Shengjing HospitalNot yet recruiting1 Year60 YearsAll130Phase 4China
74NCT02960646
(ClinicalTrials.gov)
January 18, 20178/11/2016Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic MalignanciesPhase I Clinical Trial Using an Engineered Peripheral Blood Graft for Haploidentical TransplantationAcute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome;Aplastic Anemia;Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Lymphoblastic Lymphoma;Myelodysplastic Syndrome;Myeloproliferative Neoplasm;Plasma Cell Myeloma;Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma;Recurrent Hodgkin Lymphoma;Recurrent Non-Hodgkin Lymphoma;Recurrent Plasma Cell Myeloma;Therapy-Related Myelodysplastic SyndromeDrug: Cyclophosphamide;Biological: Filgrastim;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Biological: Rituximab;Drug: Tacrolimus;Radiation: Total-Body IrradiationM.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruiting18 Years65 YearsAll11Phase 1United States
75ChiCTR1900023509
2017-01-012019-05-31Allogeneic Hematopoietic Stem Cell Transplantation with Risk-adapted Conditioning Regimens for Children with Aplastic Anemia or Refractory Cytopenia of Childhood: a Single-Center Prospective TrialAllogeneic Hematopoietic Stem Cell Transplantation with Risk-adapted Conditioning Regimens for Children with Aplastic Anemia or Refractory Cytopenia of Childhood: a Single-Center Prospective Trial aplastic anemia,Refractory Cytopenia of Childhood1:Fludarabine150 mg/m2 +Cyclophosphamide200 mg/kg+ Thymoglobuline10mg/kg;2:Fludarabine200 mg/m2 +Cyclophosphamide120 mg/kg+ Thymoglobuline10mg/kg+300cGy TBI;3:Fludarabine200 mg/m2 +Cyclophosphamide120 mg/kg+ Thymoglobuline10mg/kg+ Busulfan 8mg/kg;Shanghai Children's Medical Center affiliated to Shanghai Jiao Tong University School of MedicineNULLRecruiting18Both1:50;2:50;3:50;China
76NCT03055078
(ClinicalTrials.gov)
January 20174/2/2017Umbilical 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 UniversityNULLRecruiting14 Years60 YearsAll10Phase 1China
77NCT02979873
(ClinicalTrials.gov)
December 19, 20161/12/2016Sirolimus (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)NULLRecruiting2 YearsN/AAll118Phase 2United States
78NCT03413306
(ClinicalTrials.gov)
December 10, 201622/12/2017Eltrombopag+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 ImmunologyNULLRecruiting2 Years18 YearsAll100Phase 3Russian Federation
79NCT02875743
(ClinicalTrials.gov)
December 7, 201618/8/2016King'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 TrustNULLCompleted18 YearsN/AAll120Phase 4United Kingdom
80EUCTR2016-001223-31-GB
(EUCTR)
11/10/201607/09/2016Incidence 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;Classification code 10059041;Term: Allogeneic peripheral haematopoietic stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 19.0;Classification code 10067862;Term: Allogeneic stem cell transplantation;Level: PT;Classification code 10038270;Term: Refractory anaemia with an excess of blasts;Classification code 10010776;Term: Constitutional aplastic anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 19.0;Classification code 10068063;Term: Aplastic anaemia relapse;Classification code 10036699;Term: Primary idiopathic aplastic anaemia;Classification code 10000880;Term: Acute myeloid leukaemia;Classification code 10001756;Term: Allogenic bone marrow transplantation therapy;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
King's College Hospital NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
150Phase 4United Kingdom
81NCT02828592
(ClinicalTrials.gov)
September 9, 20166/7/2016Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic AnemiaA Study of T-Cell Replete, HLA-Mismatched Haploidentical Bone Marrow Transplantation With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia Lacking HLA-Matched Related DonorSevere Aplastic AnemiaDrug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation;Drug: Rabbit ATGNorthside Hospital, Inc.NULLRecruiting1 Year75 YearsAll20Phase 2United States
82NCT02833805
(ClinicalTrials.gov)
September 201612/7/2016NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic AnemiaA Phase II Trial of Non-Myeloablative (NMA) Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Donor (MUD) Bone Marrow for Newly Diagnosed Patients With Severe Aplastic AnemiaSevere Aplastic Anemia;Aplastic Anemia;Bone Marrow Failure;ImmunosuppressionDrug: Thymoglobulin;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total body irradiation;Drug: Tacrolimus;Drug: Mycophenolate mofetilSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNULLCompletedN/AN/AAll21Phase 2United States
83ChiCTR-IOR-16008738
2016-08-012016-06-28A 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 anemia aplastic anemiaA:Cyclosporin;B:Cyclosporin and Stanozolol;The First Affiliated Hospital of Zhengzhou UniversityNULLRecruiting1865BothA:100;B:100;China
84NCT02857530
(ClinicalTrials.gov)
August 201626/7/2016Efficacy 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 HospitalNULLNot yet recruiting6 Years60 YearsBoth250Phase 2China
85NCT02845596
(ClinicalTrials.gov)
August 20169/5/2016Unrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic AnemiaUnrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: cyclosporine;Procedure: Matched Unrelated Donor Hematopoietic Stem Cell Transplant;Drug: horse anti-thymocyte globulin (ATG);Drug: rabbit anti-thymocyte globulin (ATG);Drug: methotrexate;Drug: fludarabine;Drug: cyclophosphamide;Radiation: low-dose total body irradiation (TBI);Procedure: Immunosuppressive Therapy (IST)Michael Pulsipher, MDNULLActive, not recruitingN/A25 YearsAll40N/AUnited States
86NCT02773290
(ClinicalTrials.gov)
May 20169/5/2016Study 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 Kirin Co., Ltd.NULLCompleted20 YearsN/AAll46Phase 2/Phase 3Japan;Korea, Republic of
87JPRN-JapicCTI-163243
01/2/201602/05/2016Phase 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 Therapy Aplastic AnemiaIntervention name : AMG531
INN of the intervention : Romiplostim
Dosage And administration of the intervention : Subcutaneous administration
Kyowa Hakko Kirin Co., Ltd.NULLcomplete20BOTH46Phase 2-3NULL
88EUCTR2014-000363-40-NL
(EUCTR)
07/01/201601/09/2015A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function.A 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. - RACE Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia.
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
INN or Proposed INN: ELTROMBOPAG
European Society for Blood and Marrow TransplantationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Spain;Netherlands
89NCT02745717
(ClinicalTrials.gov)
January 20167/4/2016The 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
90NCT02566304
(ClinicalTrials.gov)
November 13, 201530/9/2015Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic MalignanciesA Two Step Approach to Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic MalignanciesAcute Myeloid Leukemia;Acute Myeloid Leukemia in Remission;Aplastic Anemia;Chronic Myelomonocytic Leukemia;Hodgkin Lymphoma;Indolent Non-Hodgkin Lymphoma;Malignant Neoplasm;Myelodysplastic Syndrome;Myeloproliferative Neoplasm;Plasma Cell Myeloma;Refractory Anemia;Refractory Anemia With Excess Blasts;Refractory Anemia With Ring Sideroblasts;Refractory Cytopenia With Multilineage Dysplasia;Refractory Cytopenia With Multilineage Dysplasia and Ring SideroblastsDrug: Fludarabine;Radiation: Total-Body Irradiation;Biological: T Cell-Depleted Donor Lymphocyte Infusion;Drug: Cyclophosphamide;Procedure: Peripheral Blood Stem Cell Transplantation;Procedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Tacrolimus;Drug: Mycophenolate mofetilSidney Kimmel Cancer Center at Thomas Jefferson UniversityNULLRecruiting18 YearsN/AAll30Phase 2United States
91EUCTR2014-000363-40-ES
(EUCTR)
26/10/201507/09/2015A trial in which will be studied if the addition of a medicine that is used for improving platelet counts (eltrombopag) to the regular treatment for aplastic anemia (hATG + CsA) also improves the numbers of other cell lines and therefore the overall bone marrow function.A 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. - RACE Idiopathic (Severe) Aplastic Anemia, a bone marrow failure syndrome which results in the normal hematopoietic tissue completely missing from the bone marrow, accounting for the subsequent pancytopenia.
MedDRA version: 18.0;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
INN or Proposed INN: ELTROMBOPAG
European Society for Blood and Marrow TransplantationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Spain
92NCT01861093
(ClinicalTrials.gov)
October 16, 201521/5/2013Safety 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 CenterRecruiting4 YearsN/AAll500Phase 2United States
93NCT02462252
(ClinicalTrials.gov)
October 201525/5/2015Phase 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.NULLRecruiting18 YearsN/AAll25Phase 2United States
94ChiCTR1900028153
2015-07-012019-12-13A Multi-centre Clinical Study of Pai-Neng-Da Capsule in the Treatment of Chronic Aplastic AnemiaA Multi-centrer Clinical Study of Pai-Neng-Da Capsule in the Treatment of Chronic Aplastic Anemia Aplstic AnemiaExperimental group:Pai-Neng-Da Capsule + Testosterone undecanoate capsule (80mg / day), cyclosporine capsule (3-7mg / kg. D);Control group:Testosterone undecanoate capsule (80mg / day), cyclosporine capsule (3-7mg / kg. D);Jinhua people's HospitalNULLCompletedBothExperimental group:50;Control group:50;Phase 2-3NULL
95NCT02099747
(ClinicalTrials.gov)
July 20156/3/2014hATG+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;PfizerActive, not recruiting15 YearsN/AAll202Phase 3France;Italy;Netherlands;Spain;Switzerland;United Kingdom;Germany
96NCT03016806
(ClinicalTrials.gov)
June 201526/12/2016Umbilical 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 TumorRadiation: Total Body Irradiation 1200 cGy;Radiation: Total Body Irradiation 200 cGy;Drug: Cyclophosphamide;Drug: Mesna;Procedure: Cord Blood Infusion;Drug: Busulfan;Drug: Fludarabine;Drug: MelphalanUniversity of RochesterNULLRecruiting2 Months75 YearsAll30Phase 1United States
97NCT02404025
(ClinicalTrials.gov)
May 12, 201526/2/2015Eltrombopag 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 TherapyAplastic AnemiaDrug: Eltrombopag;Drug: Rabbit ATG;Drug: CsANovartis PharmaceuticalsNULLCompleted18 Years75 YearsAll10Phase 2Japan
98NCT02773225
(ClinicalTrials.gov)
January 27, 201529/2/2016Efficacy 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. HöchsmannNULLRecruiting18 YearsN/AAll116Phase 2/Phase 3Germany
99EUCTR2014-000174-19-DE
(EUCTR)
27/01/201501/09/2014Efficacy 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 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 Eltrombopagwith Placebo in Patients with Acquired Moderate Aplastic Anemia who are treated with Ciclosporin A - EMAA Moderate Aplastic Anemia (MAA);Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Trade Name: Revolade 75 mg
Product Name: Eltrombopag
Product Code: SB497115
INN or Proposed INN: Eltrombopag
Other descriptive name: ELTROMBOPAG OLAMINE
Universitätsklinikum UlmNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2;Phase 3France;Netherlands;Germany;Italy;Switzerland
100EUCTR2014-001546-25-NL
(EUCTR)
06/01/201519/11/2014Short versus extended antibiotic treatment for fever during low white blood cell counts in hematology patients with fever of unknown origin.Short versus extended antibiotic treatment with a carbapenem for high-risk febrile neutropenia in hematology patients with Fever of Unknown Origin: a randomized multicenter open-label non-inferiority trial. - SHORT-trial Febrile neutropenia
MedDRA version: 19.1;Level: PT;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 19.1;Level: LLT;Classification code 10002969;Term: Aplastic anemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 19.1;Classification code 10003999;Term: Bacteremia;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.1;Classification code 10007810;Term: Catheter related infection;Classification code 10028566;Term: Myeloma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 19.1;Classification code 10062957;Term: Catheter bacteraemia;Classification code 10025310;Term: Lymphoma;Classification code 10024329;Term: Leukemia;Classification code 10056520;Term: Catheter site infection;Classification code 10016288;Term: Febrile neutropenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: imipenem-cilastatine
Product Name: imipenem / cilastatine
Product Code: RVG 101614
INN or Proposed INN: IMIPENEM
INN or Proposed INN: Cilastatin
Other descriptive name: CILASTATIN
Trade Name: Meropenem
Product Name: meropenem
Product Code: RVG 105155
INN or Proposed INN: Meropenem
Other descriptive name: MEROPENEM
VU University Medical CenterNULLNot RecruitingFemale: yes
Male: yes
240Phase 4Netherlands
101ChiCTR-IPR-14005720
2015-01-012014-12-17A 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 anemia severe aplastic anemiaTPO:rTPO;Ciclosporine:Ciclosporine;Blood Diseases Hospital, Chinese Academy of Medical SciencesNULLRecruiting1875BothTPO:86;Ciclosporine:86;I (Phase 1 study)China
102NCT02407470
(ClinicalTrials.gov)
January 201525/3/2015Safety 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
103NCT02162420
(ClinicalTrials.gov)
January 201510/6/2014Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic AnemiaHematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic AnemiaDyskeratosis Congenita;Aplastic AnemiaDrug: Alemtuzumab;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation;Biological: Stem Cell Transplant;Drug: Anti-thymocyte globulinMasonic Cancer Center, University of MinnesotaNULLRecruitingN/A70 YearsAll50N/AUnited States
104EUCTR2014-000584-41-IT
(EUCTR)
23/10/201415/04/2014Phase 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 disordersPhase 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 HSCT Hematological disorders (ALL;AML;Non-Hodgkin lymphoma;Myelodysplasticsyndromes;Congenital immune deficiencies;Severe aplastic anemia;Fanconi anemia; Osteopetrosis;Selected cases of hemoglobinopathies)
MedDRA version: 16.1;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: BPX-501 cells
Product Name: AP1903
Bellicum Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
30Phase 1;Phase 2Italy;United Kingdom;Spain
105NCT02203396
(ClinicalTrials.gov)
August 201427/7/2014A 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 ZhengNULLRecruiting6 Years70 YearsBoth40Phase 2China
106NCT02224872
(ClinicalTrials.gov)
August 201418/8/2014Transplantation of Partially Mismatched Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic AnemiaA Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia and Other Bone Marrow Failure SyndromesSevere Aplastic Anemia;Bone Marrow Failure SyndromesProcedure: Bone marrow transplant;Drug: Thymoglobulin;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: TBI;Drug: Mesna;Drug: Tacrolimus;Drug: Mycophenolic acid mofetilSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNULLCompletedN/A73 YearsAll18Phase 2United States
107NCT02148133
(ClinicalTrials.gov)
July 23, 201422/5/2014A 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 PharmaceuticalsNULLCompleted18 Years79 YearsAll21Phase 2Japan
108NCT01818726
(ClinicalTrials.gov)
June 23, 20145/3/2013Safety 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: ICL670;Drug: Chelation;Drug: No chelationNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll15Phase 4Russian Federation
109NCT02094417
(ClinicalTrials.gov)
April 14, 201418/3/2014A 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 Kirin Korea Co., Ltd.NULLCompleted19 YearsN/AAll35Phase 2Korea, Republic of
110NCT02055456
(ClinicalTrials.gov)
February 20143/2/2014Nandrolone 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
111NCT01917708
(ClinicalTrials.gov)
January 201424/7/2013Bone Marrow Transplant With 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 UniversityNULLCompletedN/A21 YearsAll10Phase 1United States
112NCT02007811
(ClinicalTrials.gov)
November 201321/11/2013Open-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
113NCT02218437
(ClinicalTrials.gov)
October 20136/8/2014Treatment 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 SciencesNULLRecruiting1 Month18 YearsBoth20Phase 4China
114NCT02028416
(ClinicalTrials.gov)
September 20132/1/2014Comparison 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, PakistanNULLRecruiting2 Years65 YearsBoth60N/APakistan
115NCT02065154
(ClinicalTrials.gov)
August 27, 20135/11/2013Post Transplant Cyclophosphamide (Cytoxan) for GvHD ProphylaxisPhase II Clinical Trial of the Use of Post-Transplant Cyclophosphamide for Graft Versus Host Disease (GvHD) Prophylaxis Following Matched Unrelated Donor (MUD) and Mismatched Unrelated Donor (MMUD)Hematopoietic Stem Cell Transplant (HSCT)Leukemia;Lymphoma;Myelodysplastic Syndrome;Myelofibrosis;Severe Aplastic Anemia;Allogeneic TransplantDrug: CyclophosphamideUniversity of Alabama at BirminghamNULLActive, not recruiting19 Years65 YearsAll41Phase 2United States
116NCT01891994
(ClinicalTrials.gov)
June 28, 201328/6/2013Extended 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)NULLActive, not recruiting2 Years100 YearsAll40Phase 2United States
117ChiCTR-PRC-13003130
2013-04-012013-03-30Voriconazole 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 anemia Severe 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 & PUMCNULLCompleted365BothTrial group:50;control:50;China
118NCT01586455
(ClinicalTrials.gov)
April 201325/4/2012Human 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 CollegeNULLActive, not recruitingN/A55 YearsAll43Phase 1United States
119NCT01966367
(ClinicalTrials.gov)
March 201317/10/2013CD34+ (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 GeorgeNULLActive, not recruitingN/A40 YearsAll37Phase 1/Phase 2United States
120NCT02247973
(ClinicalTrials.gov)
February 201317/9/2014Mesenchymal 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 HospitalEnrolling by invitation14 Years50 YearsBoth100Phase 2China
121NCT01760096
(ClinicalTrials.gov)
January 20131/1/2013Safety 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 HospitalNULLActive, not recruiting18 YearsN/ABoth50Phase 2China
122NCT01849237
(ClinicalTrials.gov)
December 20121/5/2013Russian 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, RussiaNULLRecruiting17 Years75 YearsBoth30Phase 1/Phase 2Russian Federation
123NCT01703169
(ClinicalTrials.gov)
November 201227/9/2012Efficacy 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 UtahNovartisCompleted18 YearsN/AAll13Phase 2United States
124NCT01759732
(ClinicalTrials.gov)
September 201230/12/2012Haploidentical Stem Cell Transplantation for Children With Acquired Severe Aplastic AnemiaHaploidentical Stem Cell Transplantation With Fixed Dose of T Cells After in Vitro T Cell Depletion Using CD3 Monoclonal Antibody for Children With Acquired Severe Aplastic AnemiaAcquired Aplastic AnemiaDrug: Fludarabine;Drug: Cyclophosphamide;Biological: anti-thymocyte globulin;Biological: filgrastim;Radiation: Total body irradiation;Procedure: CD3-depleted hematopoietic cell transplantationAsan Medical CenterNULLRecruitingN/A21 YearsBoth10Phase 2Korea, Republic of
125NCT01623167
(ClinicalTrials.gov)
July 2, 201214/6/2012Eltrombopag With Standard Immunosuppression for Severe Aplastic AnemiaEltrombopag Added to Standard Immunosuppression in Treatment-Naive Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: Cohort 1: hATG, CsA, EPAG Day 14 to Month 6;Drug: Cohort 2: hATG, CsA, EPAG Day 14 to Month 3;Drug: Cohort 3: hATG, CsA (dose reduced), EPAG day 1 to month 6;Drug: Extension CohortNational Heart, Lung, and Blood Institute (NHLBI)NovartisRecruiting2 Years95 YearsAll207Phase 1/Phase 2United States
126NCT01659606
(ClinicalTrials.gov)
July 20126/8/2012Radiation- 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;University of Wisconsin, Madison;Karolinska University Hospital;Hackensack Meridian Health;Duke University;Oslo University Hospital;Children's Mercy Hospital Kansas City;Mayo Clinic;University of Chicago;Massachusetts General HospitalRecruitingN/A65 YearsAll40Phase 2United States;Norway;Sweden
127NCT01642979
(ClinicalTrials.gov)
July 201214/7/2012Safety 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 HospitalNULLActive, not recruiting18 YearsN/ABoth120Phase 2China
128NCT01624805
(ClinicalTrials.gov)
June 25, 201219/6/2012Methylprednisolone, 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
129JPRN-UMIN000011134
2012/05/2308/07/2013A prospective randomized dose comparison multicenter study of the rabbit anti-thymocyte globulin (thymoglobulin, Genzyme) for patients with severe and very severe aplastic anemia Acquired Aplastic Anemia2.5 mg/kg/day of Thymoglobulin for 5 days

3.5 mg/kg/day of Thymoglobulin for 5 days
Nagoya UniversityNULLComplete: follow-up continuingNot applicable69years-oldMale and Female320Not selectedJapan,Asia(except Japan)
130NCT01844635
(ClinicalTrials.gov)
May 201229/4/2013Randomised 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 UniversityNULLRecruitingN/A69 YearsBoth320Phase 3Japan
131EUCTR2011-005152-34-ES
(EUCTR)
26/03/201222/11/2011Clinical 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 neutropenia In-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]
INN or Proposed INN: ACICLOVIR
Other descriptive name: ACICLOVIR
INN or Proposed INN: AMIKACIN
Other descriptive name: AMIKACIN
INN or Proposed INN: AMPHOTERICINE B, LIPOSOME
Other descriptive name: AMPHOTERICINE B, LIPOSOME
INN or Proposed INN: CASPOFUNGIN ACETATE
Other descriptive name: CASPOFUNGIN ACETATE
INN or Proposed INN: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
Other descriptive name: CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: CIPROFLOXACIN
Other descriptive name: CIPROFLOXACIN
INN or Proposed INN: TRIMETHOPRIM SULFATE
Other descriptive name: TRIMETHOPRIM SULFATE
INN or Proposed INN: SULFAMETH
José Miguel Cisneros HerrerosNULLNot RecruitingFemale: yes
Male: yes
Phase 3Spain
132NCT01995331
(ClinicalTrials.gov)
March 201221/11/2013Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic AnemiaModerate-dose Cyclophosphamide for Childhood Acquired Aplastic AnemiaAplastic AnemiaDrug: cyclophosphamide,cyclosporine AXiaofan ZhuNULLActive, not recruiting1 Year18 YearsBoth30Phase 4China
133NCT01529827
(ClinicalTrials.gov)
February 28, 20126/2/2012Fludarabine 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 IrradiationAccelerated 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 Leukemia;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;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 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 SyndromeDrug: 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 InstituteNULLCompleted3 Years75 YearsAll94Phase 2United States
134NCT01553461
(ClinicalTrials.gov)
February 21, 201213/3/2012Transplants 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 AnemiaBiological: Cord Blood TransplantNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting4 Years99 YearsAll500Phase 1/Phase 2United States
135NCT01500161
(ClinicalTrials.gov)
November 201118/11/2011Pooled 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 CenterNULLTerminated18 Years65 YearsBoth1Phase 2United States
136NCT01546415
(ClinicalTrials.gov)
October 201110/11/2011Safety 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 PharmaceuticalsNULLCompleted18 YearsN/ABoth64Phase 4China
137NCT01472055
(ClinicalTrials.gov)
October 20116/11/2011Pharmacokinetic 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
138NCT01351545
(ClinicalTrials.gov)
October 20119/5/2011A 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;Autoimmune 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/AAll99999United States
139NCT01384513
(ClinicalTrials.gov)
August 4, 201127/6/2011A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological MalignanciesA Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic MalignanciesAdult Acute 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 UniversityNULLActive, not recruiting18 YearsN/AAll40Phase 2United States
140JPRN-UMIN000006071
2011/08/0131/08/2011Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin SAAConditioning regimen
Fludarabine
30mg/m2/day iv day-6,-5,-4,-3
Cyclophosphamide
25mg/kg/day iv day-6,-5,-4,-3
ATG(thymoglobulin)
1.25mg/kg iv day-4,-3

In case of HSCT from unrelated donor or HLA-mismatched related donor,
TBI 2Gy day-1 will be added.
Kanto Study Group for Cell TherapyNULLComplete: follow-up complete16years-old65years-oldMale and Female28Phase 2Japan
141NCT01441037
(ClinicalTrials.gov)
July 19, 201124/9/2011Danazol for Genetic Bone Marrow and Lung DisordersMale Hormones for Telomere Related DiseasesAplastic AnemiaDrug: DanazolNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted2 YearsN/AAll27Phase 1/Phase 2United States
142NCT01408342
(ClinicalTrials.gov)
July 201129/7/2011Alemtuzumab 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. GonzalezNULLWithdrawn12 MonthsN/ABoth0N/AMexico
143NCT01267643
(ClinicalTrials.gov)
May 201120/12/2010Alefacept 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.Terminated18 YearsN/AAll4Phase 1United States
144NCT01328587
(ClinicalTrials.gov)
April 1, 20111/4/2011Eltrombopag 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)NULLActive, not recruiting2 Years100 YearsAll34Phase 2United States
145NCT01343680
(ClinicalTrials.gov)
April 201127/4/2011Trial 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 HospitalTerminatedN/A17 YearsBoth2Phase 3Canada
146NCT01305694
(ClinicalTrials.gov)
February 201128/2/2011Mesenchymal 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
147NCT01297972
(ClinicalTrials.gov)
February 201116/2/2011Mesenchymal 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 PauloNULLCompleted18 Years65 YearsBoth9Phase 1/Phase 2Brazil
148NCT01174108
(ClinicalTrials.gov)
December 10, 201031/7/2010Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cellsAllogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-CellsSevere Aplastic Anemia;MDS (Myelodysplastic Syndrome)Device: Miltenyi CD34 Reagent System;Other: Donor derived G-CSF mobilized PBCNational Heart, Lung, and Blood Institute (NHLBI)NULLRecruiting4 Years80 YearsAll120Phase 2United States
149NCT01997372
(ClinicalTrials.gov)
December 20101/3/2012Different Doses of Anti-thymocyte Globin to Treat Child Severe Aplastic AnemiaDifferent Doses of Anti-thymocyte Globin With 2.5 or 3.75mg/kg to Treat Child Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: ATGChinese Academy of Medical SciencesNULLRecruiting1 Year18 YearsBoth100Phase 4China
150NCT01199562
(ClinicalTrials.gov)
December 20108/9/2010Infection 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)Completed18 YearsN/AAll153United States
151JPRN-UMIN000004264
2010/11/0101/11/2010A 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, including1. Acute myelogenous leukemia2. Acute lymphoblastic leukemia3. Myelodysplastic syndrome4. Chronic myelogenous leukemia5. Malignant lymphoma6. 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 UniversityComplete: follow-up complete15years-old69years-oldMale and Female10Phase 1Japan
152NCT01319851
(ClinicalTrials.gov)
September 201015/9/2010Alefacept 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 AtlantaTerminatedN/A21 YearsAll3N/AUnited States
153NCT01182662
(ClinicalTrials.gov)
August 201011/8/2010Safety 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
154NCT01191749
(ClinicalTrials.gov)
August 201027/8/2010Alemtuzumab 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 CenterNULLTerminatedN/AN/AAll7Phase 2United States
155NCT01187017
(ClinicalTrials.gov)
August 201020/8/2010A Pilot Study of Fludarabine Plus Cyclophosphamide in Refractory Severe Aplastic AnemiaA Pilot Study of Fludarabine Plus Cyclophosphamide in Refractory Severe Aplastic AnemiaAplastic Anemia;Neutropenia;Pancytopenia;Severe Aplastic AnemiaDrug: Cyclophosphamide;Drug: FludarabineNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted2 YearsN/AAll1Phase 1/Phase 2United States
156NCT01193283
(ClinicalTrials.gov)
August 201031/8/2010Cyclophosphamide Plus Cyclosporine in Treatment-Naive Severe Aplastic AnemiaCyclophosphamide Plus Cyclosporine in Treatment-Naive Severe Aplastic AnemiaAplastic Anemia;Neutropenia;Pancytopenia;Severe Aplastic AnemiaDrug: Cyclophosphamide;Drug: CyclosporineNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted2 YearsN/AAll22Phase 1/Phase 2United States
157NCT01350245
(ClinicalTrials.gov)
July 20104/5/2011Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative DonorA Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies in Remission From HLA Partially-Matched Related DonorsAcute Myeloid Leukemia;Myelodysplastic Syndromes;Biphenotypic Leukemia;Acute Lymphocytic Leukemia;Chronic Myeloid Leukemia;Chronic Lymphocytic Leukemia;Plasma Cell Neoplasms;Lymphoma;Hodgkin's Disease;Aplastic AnemiaRadiation: Total Body Irradiation (TBI);Biological: Donor Lymphocyte Infusion (DLI);Drug: Cyclophosphamide;Drug: Mycophenolate Mofetil (MMF);Drug: Tacrolimus;Device: Hematopoietic stem cell transplantation (HSCT)Sidney Kimmel Cancer Center at Thomas Jefferson UniversityNULLCompleted18 YearsN/AAll28Phase 2United States
158NCT01145976
(ClinicalTrials.gov)
March 201019/5/2010Comparison of Cy-Atg vs Flu-Atg for the Conditioning Therapy in Allo-HCT for Adult Aplastic AnemiaRandomized Comparison of Cyclophosphamide Versus Fludarabine in Addition to Anti-thymocyte Globulin for the Conditioning Therapy in Allogeneic Hematopoietic Cell Transplantation for Adult Acquired Aplastic AnemiaAplastic AnemiaDrug: Cy-ATG;Drug: Flu-ATGCooperative Study Group A for HematologyNULLRecruiting15 Years65 YearsBoth98Phase 3Korea, Republic of
159EUCTR2007-000902-55-DE
(EUCTR)
17/12/200929/09/2009Prospective Phase II Pilot study of Rabbit Antithymocyte globulin(ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients withAcquired Aplastic Anaemia and comparison with matched historicalpatients treated with horse ATG and Ciclosporin: a Study from theEuropean Blood and Marrow Transplant (EBMT) Severe AplasticAnaemia Working PartyProspective Phase II Pilot study of Rabbit Antithymocyte globulin(ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients withAcquired Aplastic Anaemia and comparison with matched historicalpatients treated with horse ATG and Ciclosporin: a Study from theEuropean Blood and Marrow Transplant (EBMT) Severe AplasticAnaemia Working Party Acquired severe aplastic anaemia and transfusion dependent non-severe aplastic anaemia
MedDRA version: 12.0;Level: LLT;Classification code 10002969;Term: Aplastic anemia
Trade Name: Thymoglobulin
Product Name: Thymoglobuline®/Thymoglobulin®
Product Code: anti-thymocyte globulin (rabbit)
EBMT (European Group for Blood and Marrow Transplantation)NULLNot RecruitingFemale: yes
Male: yes
35Phase 2France;Germany;United Kingdom
160NCT01129323
(ClinicalTrials.gov)
November 200921/4/2010Reduced-Intensity Preparative Regimen for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic AnemiaReduced-Intensity Preparative Regimen for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic AnemiaSevere Aplastic AnemiaDrug: Cyclophosphamide, Fludarabine, Rabbit ATGCity of Hope Medical CenterNULLWithdrawnN/A21 YearsBoth0N/AUnited States
161EUCTR2008-005594-35-BE
(EUCTR)
28/10/200906/08/2009Randomized 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. - NA Hematological 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
CHU Sart-TilmanNULLNot RecruitingFemale: yes
Male: yes
172Phase 3Belgium
162NCT00987480
(ClinicalTrials.gov)
September 25, 200930/9/2009Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and FludarabineA Multicenter Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and FludarabineAplastic Anemia;Leukemia;Myelodysplastic SyndromeDrug: Busulfan, fludarabine, & cyclophosphamide with immunosuppression with ATG and cyclosporine.;Device: CliniMACS deviceMemorial Sloan Kettering Cancer CenterBoston Children's Hospital;Children's Hospital Medical Center, Cincinnati;Children's Hospital and Health System Foundation, Wisconsin;Rockefeller University;Fred Hutchinson Cancer Research CenterCompletedN/AN/AAll45Phase 2United States
163NCT00944749
(ClinicalTrials.gov)
July 200922/7/2009Horse 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)NULLCompleted2 Years82 YearsAll23Phase 2United States
164NCT01224496
(ClinicalTrials.gov)
July 20093/10/2010Traditional 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 CenterCompleted13 Years85 YearsAll38Phase 1/Phase 2Singapore
165NCT01105273
(ClinicalTrials.gov)
July 20098/4/2010Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Aplastic AnemiaHLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3±CD19 Depletion for Patients With Aplastic Anemia After Conditioning of Fludarabine, Cyclophosphamide and Antithymocyte GlobulinAplastic AnemiaBiological: anti-thymocyte globulin;Biological: filgrastim;Drug: Fludarabine;Drug: Cyclophosphamide;Procedure: CD3±CD19 depleted hematopoietic stem cell transplantationAsan Medical CenterNULLCompletedN/A21 YearsBoth12Phase 1/Phase 2Korea, Republic of
166NCT00922883
(ClinicalTrials.gov)
May 29, 200916/6/2009A 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)NULLCompleted12 YearsN/AAll43Phase 2United States
167EUCTR2009-012746-23-IT
(EUCTR)
12/05/200924/06/2009pilot 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 - ND acquired aplastic anemia
MedDRA version: 9.1;Level: SOC;Classification code 10005329
Trade Name: ENBREL*SC 4FL 25MG+4SIR 1ML
INN or Proposed INN: Etanercept
ISTITUTO GIANNINA GASLININULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
168NCT00856388
(ClinicalTrials.gov)
January 14, 20094/3/2009Fludarabine 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 MacroglobulinemiaDrug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiation;Procedure: allogeneic hematopoietic stem cell transplantation;Biological: anti-thymocyte globulinRoswell Park Cancer InstituteNational Cancer Institute (NCI)Completed3 Years75 YearsAll62N/AUnited States
169NCT00993694
(ClinicalTrials.gov)
January 20099/10/2009Methemoglobinemia 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)CompletedN/A18 YearsAll41N/AUnited States
170NCT00882323
(ClinicalTrials.gov)
November 200815/4/2009Reduced Toxicity Fludarabine (Flu) + Cyclophosphamide (CPM) + Rabbit Antithymocyte Globulin (rATG) Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia (SAA)Reduced Toxicity Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic AnemiaAplastic AnemiaDrug: Cyclophosphamide, Fludarabine, ThymoglobulinThe Korean Society of Pediatric Hematology OncologyNULLRecruiting1 Year21 YearsBoth33Phase 2Korea, Republic of
171NCT00471848
(ClinicalTrials.gov)
August 20089/5/2007Rabbit 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 CompanyActive, not recruiting16 YearsN/ABoth35Phase 2France;Germany;Italy;Saudi Arabia;Switzerland;United Kingdom
172NCT00604201
(ClinicalTrials.gov)
May 21, 20088/1/2008Stem Cell Transplant Using Peripheral and Cord Blood Stem Cells to Treat Severe Aplastic Anemia and Myelodysplastic 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)NULLActive, not recruiting4 Years75 YearsAll31Phase 2United States
173EUCTR2007-000902-55-FR
(EUCTR)
23/04/200804/10/2007Prospective Phase II Pilot 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 CiclosporinProspective Phase II Pilot 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 Ciclosporin Aquired aplastic anaemia and transfusion dependent non-severe aplastic anaemia
MedDRA version: 9.1;Level: LLT;Classification code 10002274;Term: Anemia aplastic
Trade Name: Thymoglobuline
Product Name: Thymoglobuline®/Thymoglobulin®
Product Code: anti-thymocyte globulin (rabbit)
Other descriptive name: GLYCINE
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: Mannitol
Trade Name: Neoral
Product Name: Ciclosporine
INN or Proposed INN: Cyclosporin A
Other descriptive name: Ciclosporine
EBMT (European group for Blood and Marrow Transplantation)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 2Germany;United Kingdom;France
174NCT01530555
(ClinicalTrials.gov)
April 200824/1/2012Prospective 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 CenterNULLCompleted16 Years80 YearsBoth35Phase 2NULL
175EUCTR2007-001657-26-GB
(EUCTR)
29/02/200807/11/2007Single Centre Phase II Pilot study of Unrelated Cord Blood Transplantation in Patients with Poor Risk Haematological Malignancies.Single Centre Phase II Pilot study of Unrelated Cord Blood Transplantation in Patients with Poor Risk Haematological Malignancies. 1.Acute, chronic leukaemia or myelodysplastic syndrome for which allogeneic transplantation is considered as the best treatment option. 2.Acute lymphoblastic leukaemia (ALL)3.Non-Hodgkin’s lymphoma4.Hodgkin’s disease5.Chronic lymphocytic leukaemia. 6.Acquired bone marrow failure syndromes7.Other haematological malignancies for which UD bone marrow transplantation is indicated
MedDRA version: 9.1;Level: LLT;Classification code 10000880;Term: Acute myeloid leukaemia
MedDRA version: 9.1;Classification code 10028533;Term: Myelodysplastic syndrome
MedDRA version: 9.1;Classification code 10009013;Term: Chronic myeloid leukaemia
MedDRA version: 9.1;Classification code 10000844;Term: Acute lymphoblastic leukaemia
MedDRA version: 9.1;Classification code 10020328;Term: Hodgkin's lymphoma
MedDRA version: 9.1;Classification code 10029593;Term: Non-Hodgkin's lymphoma NOS
MedDRA version: 9.1;Classification code 10003892;Term: B-cell chronic lymphocytic leukaemia/prolymphocytic leukaemia/small lymphocytic lymphoma
MedDRA version: 9.1;Classification code 10002968;Term: Aplastic anaemia, unspecified
Trade Name: Fludarabine
INN or Proposed INN: FLUDARABINE PHOSPHATE
Trade Name: Busilvex
INN or Proposed INN: BUSULFAN
Trade Name: Thymoglobulin
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN
Trade Name: Thiotepa
INN or Proposed INN: THIOTEPA
Trade Name: Cyclophosphamide
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Trade Name: Alkeran
INN or Proposed INN: MELPHALAN
King's College Hospital NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
27Phase 2United Kingdom
176NCT00556400
(ClinicalTrials.gov)
November 20079/11/2007Treatment 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)NULLTerminated12 Years55 YearsFemale1Phase 1/Phase 2United States
177EUCTR2007-000902-55-GB
(EUCTR)
19/09/200726/06/2007Prospective 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 CiclosporinProspective 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 Ciclosporin Acquired severe aplastic anaemia and transfusion dependent non-severe aplastic anaemia
MedDRA version: 14.0;Level: LLT;Classification code 10002274;Term: Anemia aplastic;System Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: Thymoglobuline
Product Name: Thymoglobuline®/Thymoglobulin®
Product Code: anti-thymocyte globulin (rabbit)
INN or Proposed INN: GLYCINE
INN or Proposed INN: Sodium chloride
INN or Proposed INN: Mannitol
EBMT (European group for Blood and Marrow Transplantation)NULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Germany;United Kingdom
178NCT00455312
(ClinicalTrials.gov)
August 200730/3/2007Stem Cell Transplant (SCT) for Dyskeratosis Congenita or SAAHematopoietic Stem Cell Transplant For Patients With Dyskeratosis Congenita and Severe Aplastic AnemiaDyskeratosis Congenita;Aplastic AnemiaDrug: Campath 1H;Drug: Cyclophosphamide;Drug: Fludarabine;Procedure: Total Body Irradiation;Procedure: Stem Cell Transplantation;Drug: antithymocyte globulin;Drug: MethylprednisoloneMasonic Cancer Center, University of MinnesotaNULLCompletedN/A70 YearsAll36Phase 2/Phase 3United States
179NCT00673114
(ClinicalTrials.gov)
August 200727/12/2007Unrelated 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 GmbHCompletedN/A55 YearsAll3Phase 1/Phase 2United States
180EUCTR2006-006577-25-SE
(EUCTR)
25/07/200711/06/2007A 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 transplantation Graft 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
INN or Proposed INN: SIROLIMUS
Other descriptive name: Rapamycin
Trade Name: Prograf
Product Name: Prograf
INN or Proposed INN: TACROLIMUS
Other descriptive name: FK-506
Trade Name: Sandimmun Neoral
Product Name: Sandimmun Neoral
INN or Proposed INN: CICLOSPORIN
Other descriptive name: CsA
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: MTX
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Finland;Sweden
181EUCTR2008-001151-22-IT
(EUCTR)
06/06/200714/06/2011ALEMTUZUMAB AND LOW-DOSE CYCLOSPORINE-A AS ALTERNATIVE IMMUNOSUPPRESSIVE TREATMENT FOR SEVERE APLASTIC ANEMIA (SAA) AND SINGLE-LINEAGE APLASTIC PATIENTS. - AlesaaALEMTUZUMAB AND LOW-DOSE CYCLOSPORINE-A AS ALTERNATIVE IMMUNOSUPPRESSIVE TREATMENT FOR SEVERE APLASTIC ANEMIA (SAA) AND SINGLE-LINEAGE APLASTIC PATIENTS. - Alesaa Aplastic anemia and single-lineage bone marrow failure
MedDRA version: 13.1;Level: PT;Classification code 10002965;Term: Aplasia pure red cell;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 13.1;Level: LLT;Classification code 10047350;Term: Very few granulocyte precursors;Classification code 10002967;Term: Aplastic anaemia;Classification code 10001507;Term: Agranulocytosis;System Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: MABCAMPATH
INN or Proposed INN: Alemtuzumab
UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO IINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Italy
182NCT00578266
(ClinicalTrials.gov)
February 200717/12/2007Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic AnemiaAllogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related DonorsAnemia, AplasticDrug: Cyclophosphamide,Campath IH and TBIMayo ClinicNULLCompletedN/A60 YearsAll8Phase 1United States
183NCT00895739
(ClinicalTrials.gov)
June 20067/5/2009Alemtuzumab 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 UniversityNULLRecruiting18 YearsN/ABoth50Phase 2Italy
184NCT00358657
(ClinicalTrials.gov)
May 24, 200628/7/2006Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant and Cyclophosphamide, Mycophenolate Mofetil, Tacrolimus, and Sirolimus in Treating Patients With Primary Immunodeficiency Disorders or Noncancerous Inherited DisordersHLA-Haploidentical Related Marrow Grafts for the Treatment of Primary Immunodeficiencies and Other Nonmalignant Disorders Using Conditioning With Low-Dose Cyclophosphamide, TBI and Fludarabine and Postgrafting CyclophosphamideImmunodeficiency Syndrome;Non-Cancer Diagnosis;Severe Aplastic Anemia;DonorProcedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Sirolimus;Drug: Tacrolimus;Radiation: Total-Body IrradiationFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI);National Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingN/A55 YearsAll14Phase 2United States
185NCT00319878
(ClinicalTrials.gov)
May 200628/4/2006Sirolimus 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
186NCT00474747
(ClinicalTrials.gov)
February 7, 200616/5/2007Fludarabine-Based Conditioning for Allogeneic Marrow Transplantation in Aplastic AnemiaFludarabine-Based Conditioning for Allogeneic Marrow Transplantation From HLA-Compatible Unrelated Donors in Severe Aplastic AnemiaAplastic AnemiaDrug: Antithymocyte Globulin;Drug: Cyclophosphamide;Drug: Fludarabine;Radiation: Total Body Irradiation (TBI);Procedure: Bone Marrow TransplantM.D. Anderson Cancer CenterNational Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI)CompletedN/A65 YearsAll5Phase 1/Phase 2United States
187NCT00343785
(ClinicalTrials.gov)
February 200622/6/2006Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow TransplantCyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia: Effect of Marrow Cell Dose on Chronic Graft-vs.-Host Disease: A Multi-Center TrialAplastic AnemiaDrug: cyclophosphamide;Biological: anti-thymocyte globulin;Drug: cyclosporine;Procedure: allogeneic bone marrow transplantation;Drug: methotrexate;Genetic: DNA analysis;Other: flow cytometry;Genetic: polymorphism analysis;Other: laboratory biomarker analysisFred Hutchinson Cancer Research CenterNational Heart, Lung, and Blood Institute (NHLBI)CompletedN/A65 YearsAll21Phase 2United States;Canada
188NCT00354419
(ClinicalTrials.gov)
February 200619/7/2006Cyclophosphamide, Antithymocyte Globulin, and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood TransplantA Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord BloodAplastic AnemiaRadiation: total-body irradiation;Drug: cyclophosphamide;Biological: anti-thymocyte globulin;Drug: cyclosporine;Procedure: umbilical cord blood transplantation;Drug: mycophenolate mofetil;Procedure: bone marrow aspiration;Genetic: DNA analysis;Biological: filgrastimFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)TerminatedN/A40 YearsBoth30Phase 1United States
189NCT00326417
(ClinicalTrials.gov)
January 200612/5/2006Fludarabine-based Conditioning for Severe Aplastic Anemia (BMT CTN 0301)Fludarabine-based Conditioning for Allogeneic Marrow Transplantation From HLA-compatible Unrelated Donors in Severe Aplastic Anemia (BMT CTN #0301)Anemia, AplasticDrug: Fludarabine;Drug: Cyclophosphamide 150mg;Drug: Cyclophosphamide 100mg;Drug: Cyclophosphamide 50mgMedical College of WisconsinNational Heart, Lung, and Blood Institute (NHLBI);Blood and Marrow Transplant Clinical Trials Network;National Cancer Institute (NCI);National Marrow Donor ProgramCompletedN/A65 YearsAll97Phase 1/Phase 2United States
190NCT00737685
(ClinicalTrials.gov)
January 200618/8/2008Flu+CPM+rATG Conditioning Regimes for Unrelated Bone Marrow Transplantation (UBMT)(or Mobilized Peripheral Blood)in Severe Aplastic Anemia (SAA)Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Bone Marrow (or Mobilized Peripheral Blood) Transplantation in Severe Aplastic AnemiaAnemia, AplasticDrug: cyclophosphamide, fludarabine , thymoglobulinThe Korean Society of Pediatric Hematology OncologyNULLActive, not recruitingN/A25 YearsBoth30Phase 2Korea, Republic of
191NCT00260689
(ClinicalTrials.gov)
November 28, 20051/12/2005Three 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)NULLCompleted2 YearsN/AAll136Phase 2United States
192NCT00438178
(ClinicalTrials.gov)
October 200521/2/2007Safety 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 XNULLCompleted18 YearsN/ABoth44Phase 1United States;Canada
193NCT00195624
(ClinicalTrials.gov)
September 15, 200516/9/2005Alemtuzumab 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)NULLCompleted2 Years110 YearsAll47Phase 2United States
194NCT00229619
(ClinicalTrials.gov)
September 200529/9/2005Rituximab 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)NULLCompleted2 YearsN/AAll11Phase 2United States
195NCT00676806
(ClinicalTrials.gov)
July 20059/5/2008A 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 CenterNULLTerminatedN/A70 YearsAll7Phase 2United States
196NCT00806598
(ClinicalTrials.gov)
May 20059/12/2008Thymoglobulin 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 CompanyCompleted15 YearsN/AAll53Phase 2United States
197NCT00295997
(ClinicalTrials.gov)
May 200523/2/2006Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic AnemiaNon-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic AnemiaChronic Myeloproliferative Disorders;Kidney Cancer;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative NeoplasmsBiological: anti-thymocyte globulin;Biological: filgrastim;Biological: graft-versus-tumor induction therapy;Biological: therapeutic allogeneic lymphocytes;Drug: busulfan;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methotrexate;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantationUniversity of California, San FranciscoNational Cancer Institute (NCI)Active, not recruitingN/A74 YearsBoth35N/AUnited States
198NCT01231841
(ClinicalTrials.gov)
March 200529/10/2010Anti-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;Biological: anti-thymocyte globulinThe Cleveland ClinicNULLCompleted12 YearsN/AAll20Phase 2United States
199EUCTR2004-004914-18-IT
(EUCTR)
21/01/200527/07/2005A 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 donor Marrow 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
INN or Proposed INN: Etanercept
ISTITUTO GIANNINA GASLININULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
200JPRN-C000000356
2004/12/0120/03/2006Evaluation of the safety and efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) using alemtuzumab for patients with aplastic anemia Aplastic 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 groupNULLComplete: follow-up complete20years-old65years-oldMale and Female38Phase 1,2Japan
201NCT00065260
(ClinicalTrials.gov)
July 200318/7/2003Rabbit 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)NULLCompleted2 YearsN/AAll54Phase 2United States
202NCT00061360
(ClinicalTrials.gov)
June 26, 200323/5/2003Improving 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)NULLCompleted2 Years110 YearsAll77Phase 2United States
203NCT00186797
(ClinicalTrials.gov)
December 20029/9/2005Purified CD34+ Hematopoietic Stem Cell Transplantation From Alternate Donors for Patients With Severe Aplastic AnemiaAplastic AnemiaProcedure: Allogeneic stem cell transplant;Drug: Fludarabine, CyclophosphamideSt. Jude Children's Research HospitalNULLCompletedN/A21 YearsBoth28N/AUnited States
204NCT00533923
(ClinicalTrials.gov)
December 200220/9/2007Nonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic DisordersNonmyeloablative Allogeneic Stem Cell Transplantation From HLA-Matched Unrelated Donor for the Treatment of Hematologic DisordersAML;ALL;CLL;Myelodysplastic Syndrome;Non-Hodgkin's Lymphoma;Hodgkin's Lymphoma;Multiple Myeloma;Aplastic Anemia;Myeloproliferative DisorderDrug: Cyclophosphamide; Fludarabine; Cyclosporin; CAMPATH-1H (Alemtuzumab); GM-CSFBeth Israel Deaconess Medical CenterBayerCompletedN/A65 YearsBoth25Phase 2United States
205NCT00399971
(ClinicalTrials.gov)
November 200214/11/2006Safety 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
206NCT00516152
(ClinicalTrials.gov)
November 200213/8/2007Phase 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 FranciscoNULLCompleted15 Years61 YearsBoth36Phase 2United States
207NCT00053157
(ClinicalTrials.gov)
June 200227/1/2003Sargramostim 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)Completed5 Years60 YearsBoth10N/AUnited States
208NCT00054236
(ClinicalTrials.gov)
May 20025/2/2003Combination Chemotherapy Followed By Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Severe Aplastic AnemiaPilot Study Of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning In Patients With Hematologic Disorders Or Severe Aplastic AnemiaChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative DiseasesBiological: anti-thymocyte globulin;Biological: filgrastim;Drug: cyclophosphamide;Drug: fludarabine phosphate;Procedure: umbilical cord blood transplantation;Drug: methylprednisoloneCase Comprehensive Cancer CenterNULLCompletedN/A120 YearsAll55Phase 1United States
209NCT00578903
(ClinicalTrials.gov)
February 200219/12/2007Allogeneic 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 MedicineTerminatedN/A60 YearsAll22Phase 2United States
210NCT00053989
(ClinicalTrials.gov)
January 29, 20025/2/2003NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/DisordersNon-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and DisordersChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Fanconi Anemia;Aplastic AnemiaBiological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Biological: sargramostim;Biological: therapeutic allogeneic lymphocytes;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methylprednisolone;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: peripheral blood stem cell transplantation;Procedure: umbilical cord blood transplantationRoswell Park Cancer InstituteNULLCompleted4 Years75 YearsAll41Phase 2United States
211NCT00590460
(ClinicalTrials.gov)
July 200126/12/2007Antibody 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 MedicineThe Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of MedicineTerminatedN/AN/AAll5Phase 1/Phase 2United States
212NCT00017654
(ClinicalTrials.gov)
April 20016/6/2001Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic AnemiaGraft Versus Host Disease;Aplastic AnemiaDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: methylprednisolone;Procedure: Allogeneic Bone Marrow TransplantationNorthwestern Memorial HospitalNULLActive, not recruiting15 Years55 YearsBoth3N/AUnited States
213NCT01163942
(ClinicalTrials.gov)
March 200114/7/2010Randomized 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-aventisTerminatedN/AN/ABoth205Phase 3Czech Republic;France;Germany;Greece;Italy;Netherlands;Sweden;Switzerland;United Kingdom
214NCT00011830
(ClinicalTrials.gov)
February 200128/2/2001Stem 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)NULLCompletedN/AN/ABoth20Phase 1United States
215NCT00427336
(ClinicalTrials.gov)
December 200025/1/2007Purine Analog-Based Conditioning in Patients With Severe Aplastic AnemiaPurine Analog-Based Conditioning for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic AnemiaAplastic AnemiaDrug: Fludarabine;Drug: Cyclophosphamide;Drug: Antithymocyte GlobulinM.D. Anderson Cancer CenterNULLCompletedN/A70 YearsAll9N/AUnited States
216NCT00006379
(ClinicalTrials.gov)
June 20004/10/2000Non-Ablative Allo HSCT For Hematologic Malignancies or SAAPurine-Analog-Containing Non-Myeloablative Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies and Severe Aplastic AnemiaChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Precancerous/Nonmalignant Condition;Small Intestine CancerBiological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Drug: cyclophosphamide;Drug: fludarabine phosphate;Procedure: peripheral blood stem cell transplantationCase Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedN/A70 YearsBoth58Phase 2United States
217NCT00005935
(ClinicalTrials.gov)
June 20006/7/2000Mycophenolate 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)NULLCompletedN/AN/ABoth130Phase 2United States
218NCT00001964
(ClinicalTrials.gov)
March 17, 200018/1/2000Combination 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)NULLCompleted1 Year99 YearsAll104Phase 2United States
219NCT01499147
(ClinicalTrials.gov)
February 200023/11/2011Fludarabine 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 ChicagoNULLCompleted10 Years65 YearsAll100N/AUnited States
220NCT00001962
(ClinicalTrials.gov)
November 199918/1/2000A 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.NULLTerminated2 YearsN/AAll100Phase 2United States
221NCT00004143
(ClinicalTrials.gov)
September 199910/12/1999Allogeneic 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, MDNULLCompleted18 YearsN/AAll2Phase 2United States
222NCT00636909
(ClinicalTrials.gov)
July 199910/3/2008Nonmyeloablative Allo SCT for the Treatment of Hematologic DisordersNonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic DisordersAML;ALL;CML Chronic Phase, Accelerated Phase, or Blast Crisis;CLL;MDS;RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA;APLASTIC ANEMIA;MULTIPLE MYELOMA;MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET)Drug: Cyclophosphamide;Drug: fludarabine;Drug: cyclosporine;Drug: methotrexate;Biological: G-CSFBeth Israel Deaconess Medical CenterAmgenCompletedN/A65 YearsAll25Phase 2NULL
223NCT00003816
(ClinicalTrials.gov)
October 19, 19981/11/1999Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic CancerAllogeneic Blood or Marrow Transplantation for Hematologic Malignancy and Aplastic AnemiaChronic Myeloproliferative Disorders;Leukemia;Lymphoma;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Nonmalignant Neoplasm;Unspecified Adult Solid Tumor, Protocol Specific;Unspecified Childhood Solid Tumor, Protocol SpecificBiological: anti-thymocyte globulin;Drug: busulfan;Drug: carboplatin;Drug: cyclophosphamide;Drug: etoposide;Drug: fludarabine phosphate;Drug: melphalan;Drug: thiotepa;Radiation: total-body irradiationRoswell Park Cancer InstituteNULLCompleted4 Years70 YearsAll362Phase 2/Phase 3United States
224NCT00004474
(ClinicalTrials.gov)
September 199818/10/1999Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic AnemiaPhase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic AnemiaAplastic AnemiaDrug: Anti-thymocyte globulin;Drug: Cyclophosphamide;Procedure: Bone marrow transplantationRoswell Park Cancer InstituteNULLCompletedN/A59 YearsAll224Phase 3United States
225NCT00003336
(ClinicalTrials.gov)
January 19981/11/1999Pilot Study Of Unrelated UCB Transplant for Non-Malignant Hematologic ConditionsA Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With Severe Aplastic Anemia, Inborn Errors in Metabolism, or Inherited Hematologic Stem Cell DisordersLeukemia;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative DiseasesBiological: anti-thymocyte globulin;Drug: busulfan;Drug: cyclophosphamide;Drug: melphalan;Drug: methylprednisolone;Procedure: bone marrow ablation with stem cell support;Procedure: umbilical cord blood transplantation;Radiation: radiation therapyCase Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedN/A55 YearsBoth6Phase 2United States
226NCT00001626
(ClinicalTrials.gov)
June 2, 19973/11/1999Comparing Therapies for the Treatment of Severe Aplastic AnemiaA Randomized Trial of Antithymocyte Globulin and Cyclosporine Versus Cyclophosphamide and Cyclosporine in the Treatment of Severe Aplastic AnemiaSevere Aplastic Anemia (SAA)Drug: antithymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporineNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted15 Years110 YearsAll33Phase 2United States
227NCT00005852
(ClinicalTrials.gov)
June 19962/6/2000Bone Marrow Transplantation in Treating Patients With Severe Aplastic Anemia or Rejection of Previous Bone Marrow TransplantAllogeneic Bone Marrow Transplantation for Marrow Failure StatesChronic Myeloproliferative Disorders;Graft Versus Host Disease;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic SyndromesBiological: anti-thymocyte globulin;Biological: filgrastim;Biological: muromonab-CD3;Drug: cyclophosphamide;Drug: cyclosporine;Drug: methylprednisolone;Procedure: allogeneic bone marrow transplantationH. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)Terminated15 Years55 YearsBothPhase 2NULL
228NCT00004464
(ClinicalTrials.gov)
February 199618/10/1999Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal HemoglobinuriaHigh Dose Cyclophosphamide for the Treatment of Severe Aplastic Anemia and Paroxysmal Nocturnal HemoglobinuriaAplastic Anemia;Paroxysmal Hemoglobinuria, NocturnalDrug: cyclophosphamide;Drug: filgrastimSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNULLCompletedN/A70 YearsAll69Phase 2United States
229NCT00002718
(ClinicalTrials.gov)
November 19951/11/1999T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Aplastic AnemiaA Phase II Trial of T-Cell Depleted Marrow Grafts Combined With Infusions of G-CSF Stimulated, CD34 Ceprate Stem Cell Column Selected, E-Rosette Depleted Peripheral Blood Progenitor Cells Derived From HLA Haplotype Matched Related Donors for Patients With Leukemia Lacking an HLA-Matched Related or Unrelated DonorLeukemia;Lymphoma;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative NeoplasmsBiological: anti-thymocyte globulin;Biological: filgrastim;Drug: cyclophosphamide;Drug: cytarabine;Drug: methylprednisolone;Drug: thiotepa;Procedure: in vitro-treated bone marrow transplantation;Procedure: in vitro-treated peripheral blood stem cell transplantation;Radiation: radiation therapyMemorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedN/A49 YearsBoth31Phase 2United States
230NCT00004323
(ClinicalTrials.gov)
February 199518/10/1999Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic AnemiaAplastic AnemiaDrug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: mesna;Drug: methotrexate;Drug: methylprednisoloneNational Center for Research Resources (NCRR)University of California, Los AngelesCompletedN/A55 YearsBoth10Phase 2United States
231NCT00001398
(ClinicalTrials.gov)
October 19933/11/1999Stem 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)NULLCompletedN/AN/ABoth40Phase 1United States
232NCT00212407
(ClinicalTrials.gov)
February 199313/9/2005New 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 CenterNULLTerminatedN/AN/AAll4476Early Phase 1United States
233NCT00000597
(ClinicalTrials.gov)
March 198227/10/1999Multi-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)NULLCompleted18 Years75 YearsBothPhase 3NULL
234EUCTR2021-002155-11-Outside-EU/EEA
(EUCTR)
09/06/2021Open-label, single-arm, multicenter study in Japanese patients with aplastic anemiaA MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ACCESS THE EFFICACY AND SAFETY OF PF-06462700 ADMINISTERED INTRAVENOUSLY AT 40 MG/KG/DAY FOR 4 DAYS IN JAPANESE PARTICIPANTS WITH MODERATE AND ABOVE APLASTIC ANEMIA Moderate and above aplastic anemia;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Trade Name: Atgam
Product Name: Atgam
INN or Proposed INN: Anti-human T-lymphocyte immunoglobulin from horse
Other descriptive name: anti-human immunoglobulin, equine
Pfizer Inc.NULLNAFemale: yes
Male: yes
Phase 3Japan
235EUCTR2014-000584-41-GB
(EUCTR)
15/07/2015Phase I/II study of CaspaCide T cells in children following aß- depleted mis-matched family donor stem cell transplantationPhase 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 HSCT Hematological disorders (ALL; AML; Non-Hodgkin lymphoma; Myelodysplastic syndromes; Congenital immune deficiencies; Severe aplastic anemia; Fanconi anemia; Osteopetrosis; Selected cases of hemoglobinopathies)
MedDRA version: 20.0;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: BPX-501 cells
INN or Proposed INN: Rivogenlecleucel
Other descriptive name: BPX-501
Product Name: rimiducid
INN or Proposed INN: Rimiducid
Other descriptive name: AP1903 A594
Bellicum Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
175Phase 2Spain;Italy;United Kingdom