60. 再生不良性貧血 Aplastic anemia Clinical trials / Disease details
臨床試験数 : 245 / 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ChiCTR1900023509 | 2017-01-01 | 2019-05-31 | Allogeneic Hematopoietic Stem Cell Transplantation with Risk-adapted Conditioning Regimens for Children with Aplastic Anemia or Refractory Cytopenia of Childhood: a Single-Center Prospective Trial | Allogeneic 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 Childhood | 1: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 Medicine | NULL | Recruiting | 18 | Both | 1:50;2:50;3:50; | China | ||
| 2 | NCT02833805 (ClinicalTrials.gov) | September 2016 | 12/7/2016 | NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia | A 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 Anemia | Severe Aplastic Anemia;Aplastic Anemia;Bone Marrow Failure;Immunosuppression | Drug: Thymoglobulin;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total body irradiation;Drug: Tacrolimus;Drug: Mycophenolate mofetil | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | NULL | Completed | N/A | N/A | All | 21 | Phase 2 | United States |
| 3 | NCT02745717 (ClinicalTrials.gov) | January 2016 | 7/4/2016 | The Efficacy of Immunosuppressive Therapy Combined With Cord Blood Transfusion in Treatment of Severe Aplastic Anemia | The Efficacy of Immunosuppressive Therapy Combined With Cord Blood Transfusion in Treatment of Severe Aplastic Anemia | Severe Aplastic Anemia | Drug: Thymoglobulin;Procedure: Cord blood;Drug: Cyclosporine Oral Product | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Ruijin Hospital;Xinhua Hospital, Shanghai Jiao Tong University School of Medicine;Shanghai Tongji Hospital, Tongji University School of Medicine;Zhejiang Provincial Hospital of TCM | Completed | N/A | 60 Years | All | 60 | Phase 4 | China |
| 4 | NCT02224872 (ClinicalTrials.gov) | August 2014 | 18/8/2014 | Transplantation of Partially Mismatched Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia | A 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 Syndromes | Severe Aplastic Anemia;Bone Marrow Failure Syndromes | Procedure: Bone marrow transplant;Drug: Thymoglobulin;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: TBI;Drug: Mesna;Drug: Tacrolimus;Drug: Mycophenolic acid mofetil | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | NULL | Completed | N/A | 73 Years | All | 18 | Phase 2 | United States |
| 5 | JPRN-UMIN000011134 | 2012/05/23 | 08/07/2013 | A prospective randomized dose comparison multicenter study of the rabbit anti-thymocyte globulin (thymoglobulin, Genzyme) for patients with severe and very severe aplastic anemia | A prospective randomized dose comparison multicenter study of the rabbit anti-thymocyte globulin (thymoglobulin, Genzyme) for patients with severe and very severe aplastic anemia - APBMT AAWG-01 | Acquired Aplastic Anemia | 2.5 mg/kg/day of Thymoglobulin for 5 days 3.5 mg/kg/day of Thymoglobulin for 5 days | Nagoya University | NULL | Complete: follow-up complete | Not applicable | 69years-old | Male and Female | 320 | Not selected | Japan,Asia(except Japan) |
| 6 | NCT01844635 (ClinicalTrials.gov) | May 2012 | 29/4/2013 | Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA | A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia | Acquired Aplastic Anemia. | Drug: Thymoglobulin | Nagoya University | NULL | Recruiting | N/A | 69 Years | Both | 320 | Phase 3 | Japan |
| 7 | JPRN-UMIN000006071 | 2011/08/01 | 31/08/2011 | Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin | Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin - HSCT for AA using low-dose ATG | SAA | Conditioning 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 Therapy | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 28 | Phase 2 | Japan |
| 8 | EUCTR2007-000902-55-DE (EUCTR) | 17/12/2009 | 29/09/2009 | Prospective 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 | Prospective 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) | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | France;Germany;United Kingdom | ||
| 9 | NCT00882323 (ClinicalTrials.gov) | November 2008 | 15/4/2009 | Reduced 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 Anemia | Aplastic Anemia | Drug: Cyclophosphamide, Fludarabine, Thymoglobulin | The Korean Society of Pediatric Hematology Oncology | NULL | Recruiting | 1 Year | 21 Years | Both | 33 | Phase 2 | Korea, Republic of |
| 10 | NCT00471848 (ClinicalTrials.gov) | August 2008 | 9/5/2007 | Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic Anaemia | Prospective 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 | Aplastic Anemia | Drug: rabbit antithymocyte globulin | European Group for Blood and Marrow Transplantation | Genzyme, a Sanofi Company | Active, not recruiting | 16 Years | N/A | Both | 35 | Phase 2 | France;Germany;Italy;Saudi Arabia;Switzerland;United Kingdom |
| 11 | EUCTR2007-000902-55-FR (EUCTR) | 23/04/2008 | 04/10/2007 | Prospective 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 | Prospective 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) | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | France;Germany;United Kingdom | ||
| 12 | NCT01530555 (ClinicalTrials.gov) | April 2008 | 24/1/2012 | Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia | Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia | Acquired Aplastic Anaemia | Drug: Rabbit ATG, Thymoglobuline (Genzyme) | King Faisal Specialist Hospital & Research Center | NULL | Completed | 16 Years | 80 Years | Both | 35 | Phase 2 | NULL |
| 13 | EUCTR2007-001657-26-GB (EUCTR) | 29/02/2008 | 07/11/2007 | Single 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 Trust | NULL | Not Recruiting | Female: yes Male: yes | 27 | Phase 2 | United Kingdom | ||
| 14 | EUCTR2007-000902-55-GB (EUCTR) | 19/09/2007 | 26/06/2007 | Prospective 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 | Prospective 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) | NULL | Not 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): no | France;Germany;United Kingdom | ||
| 15 | NCT00737685 (ClinicalTrials.gov) | January 2006 | 18/8/2008 | Flu+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 Anemia | Anemia, Aplastic | Drug: cyclophosphamide, fludarabine , thymoglobulin | The Korean Society of Pediatric Hematology Oncology | NULL | Active, not recruiting | N/A | 25 Years | Both | 30 | Phase 2 | Korea, Republic of |
| 16 | NCT00806598 (ClinicalTrials.gov) | May 2005 | 9/12/2008 | Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome | Phase 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 Syndrome | Myelodysplastic Syndrome;Aplastic Anemia | Drug: Thymoglobulin;Drug: Cyclosporine;Drug: Methylprednisolone;Drug: G-CSF | M.D. Anderson Cancer Center | Genzyme, a Sanofi Company | Completed | 15 Years | N/A | All | 53 | Phase 2 | United States |