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 | NCT03173937 (ClinicalTrials.gov) | June 13, 2017 | 31/5/2017 | Unrelated 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 Outcome | Unrelated 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 Outcome | Severe Aplastic Anemia;Hypo-Plastic MDS;Myelodysplastic Syndrome (MDS) | Biological: Omidubicel (former CordIn) | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Recruiting | 4 Years | 75 Years | All | 37 | Phase 1/Phase 2 | United States |
| 2 | NCT01553461 (ClinicalTrials.gov) | February 21, 2012 | 13/3/2012 | Transplants With Unlicensed Preserved Cord Blood | 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 Indications | Myelodysplastic Syndrome (MDS);Hematologic Neoplasms;Hematologic Diseases;Severe Aplastic Anemia | Biological: Cord Blood Transplant | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Recruiting | 4 Years | 99 Years | All | 500 | Phase 1/Phase 2 | United States |
| 3 | NCT01500161 (ClinicalTrials.gov) | November 2011 | 18/11/2011 | Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match | A 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 Donor | Acute Myelogenous Leukemia;Acute Lymphocytic Leukemia;Chronic Lymphocytic Leukemia;Chronic Myelogenous Leukemia;Hodgkins Disease;Non-Hodgkins Lymphoma;Aplastic Anemia;Multiple Myeloma;Myelodysplastic Syndrome | Drug: Busulfan;Drug: Clofarabine;Drug: Fludarabine;Drug: Melphalan;Drug: Carmustine;Drug: Etoposide;Drug: Cytarabine | Texas Oncology Cancer Center | NULL | Terminated | 18 Years | 65 Years | Both | 1 | Phase 2 | United States |
| 4 | JPRN-UMIN000004264 | 2010/11/01 | 01/11/2010 | A 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) | A 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) - A PK/Phase I study of i.v. MMF for GVHD prophylaxis | Refractory hematologic disorders, including1. Acute myelogenous leukemia2. Acute lymphoblastic leukemia3. Myelodysplastic syndrome4. Chronic myelogenous leukemia5. Malignant lymphoma6. Aplastic anemia | For 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 Medicine | School of Pharmacy and Pharmaceutical Science, Mukogawa Women's University | Complete: follow-up complete | 15years-old | 69years-old | Male and Female | 10 | Phase 1 | Japan |
| 5 | 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 | ||
| 6 | NCT00673114 (ClinicalTrials.gov) | August 2007 | 27/12/2007 | Unrelated Cord Blood Transplant Plus a Haplo-Identical (Half-Matched), T-Cell Depleted Stem Transplant From a Related Donor for Subjects With High Risk Malignancies | A 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 Malignancies | Hematologic Malignancy;Myelodysplastic Syndrome (MDS);Aplastic Anemia | Biological: haplo/cord transplant | Joanne Kurtzberg, MD | Miltenyi Biotec GmbH | Completed | N/A | 55 Years | All | 3 | Phase 1/Phase 2 | United States |
| 7 | NCT00354419 (ClinicalTrials.gov) | February 2006 | 19/7/2006 | Cyclophosphamide, Antithymocyte Globulin, and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood Transplant | A Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord Blood | Aplastic Anemia | Radiation: 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: filgrastim | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Terminated | N/A | 40 Years | Both | 30 | Phase 1 | United States |
| 8 | NCT00676806 (ClinicalTrials.gov) | July 2005 | 9/5/2008 | A Phase II Study of Umbilical Cord Blood Transplantation | A Phase II Study of Umbilical Cord Blood Transplantation Following Myeloablative or Reduced-Intensity Conditioning | Leukemia;Lymphoma;Multiple Myeloma;Aplastic Anemia | Biological: Umbilical Cord Blood After Myeloablative Conditioning;Biological: Umbilical Cord Blood After Reduced-Intensity Conditioning | Tufts Medical Center | NULL | Terminated | N/A | 70 Years | All | 7 | Phase 2 | United States |
| 9 | NCT00054236 (ClinicalTrials.gov) | May 2002 | 5/2/2003 | Combination Chemotherapy Followed By Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Severe Aplastic Anemia | Pilot Study Of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning In Patients With Hematologic Disorders Or Severe Aplastic Anemia | Chronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases | Biological: anti-thymocyte globulin;Biological: filgrastim;Drug: cyclophosphamide;Drug: fludarabine phosphate;Procedure: umbilical cord blood transplantation;Drug: methylprednisolone | Case Comprehensive Cancer Center | NULL | Completed | N/A | 120 Years | All | 55 | Phase 1 | United States |
| 10 | NCT00053989 (ClinicalTrials.gov) | January 29, 2002 | 5/2/2003 | NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders | Non-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Disorders | Chronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Fanconi Anemia;Aplastic Anemia | Biological: 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 transplantation | Roswell Park Cancer Institute | NULL | Completed | 4 Years | 75 Years | All | 41 | Phase 2 | United States |
| 11 | NCT00003336 (ClinicalTrials.gov) | January 1998 | 1/11/1999 | Pilot Study Of Unrelated UCB Transplant for Non-Malignant Hematologic Conditions | A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With Severe Aplastic Anemia, Inborn Errors in Metabolism, or Inherited Hematologic Stem Cell Disorders | Leukemia;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases | Biological: 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 therapy | Case Comprehensive Cancer Center | National Cancer Institute (NCI) | Completed | N/A | 55 Years | Both | 6 | Phase 2 | United States |
| 12 | NCT00212407 (ClinicalTrials.gov) | February 1993 | 13/9/2005 | New York Blood Center National Cord Blood Program | New York Blood Center National Cord Blood Program | Leukemia;Lymphoma;Genetic Disease;Severe Aplastic Anemia;Myelodysplasia | Biological: Umbilical Cord Blood Transplantation | New York Blood Center | NULL | Terminated | N/A | N/A | All | 4476 | Early Phase 1 | United States |