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. | 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 |
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| 1 | JPRN-jRCTs071190032 | 26/11/2019 | 21/10/2019 | W-JHS AA02 | Investigation on the effectiveness of rabbit ATG + cyclosporine + eltrombopag therapy for patients with aplastic anemia - W-JHS AA02 | aplastic anemia | 1. 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 Ken | NULL | Recruiting | >= 18age old | < 80age old | Both | 60 | Phase 2 | Japan |
| 2 | NCT03579875 (ClinicalTrials.gov) | November 13, 2018 | 25/5/2018 | T Cell Receptor a/ß TCD HCT in Patients With Fanconi Anemia | T 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 Syndromes | Drug: 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: Busulfan | Masonic Cancer Center, University of Minnesota | NULL | Recruiting | N/A | 65 Years | All | 48 | Phase 2 | United States |
| 3 | NCT02462252 (ClinicalTrials.gov) | October 2015 | 25/5/2015 | Phase 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 Syndrome | A 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 Syndrome | Drug: BL-8040;Drug: horse anti-thymocyte globulin (hATG);Drug: Methylprednisolone;Drug: Cyclosporine | BioLineRx, Ltd. | NULL | Recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 4 | NCT01624805 (ClinicalTrials.gov) | June 25, 2012 | 19/6/2012 | Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome | Phase 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 Syndrome | Biological: Anti-Thymocyte Globulin;Drug: Cyclosporine;Biological: Filgrastim;Drug: Methylprednisolone;Biological: Pegfilgrastim | M.D. Anderson Cancer Center | National Cancer Institute (NCI) | Recruiting | N/A | N/A | All | 100 | Phase 2 | United States |
| 5 | NCT00455312 (ClinicalTrials.gov) | August 2007 | 30/3/2007 | Stem Cell Transplant (SCT) for Dyskeratosis Congenita or SAA | Hematopoietic Stem Cell Transplant For Patients With Dyskeratosis Congenita and Severe Aplastic Anemia | Dyskeratosis Congenita;Aplastic Anemia | Drug: Campath 1H;Drug: Cyclophosphamide;Drug: Fludarabine;Procedure: Total Body Irradiation;Procedure: Stem Cell Transplantation;Drug: antithymocyte globulin;Drug: Methylprednisolone | Masonic Cancer Center, University of Minnesota | NULL | Completed | N/A | 70 Years | All | 36 | Phase 2/Phase 3 | United States |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | NCT00017654 (ClinicalTrials.gov) | April 2001 | 6/6/2001 | Study of Allogeneic Bone Marrow and T-Cell Depleted, CD34+ Peripheral Blood Stem Cell Transplantation in Patients With Aplastic Anemia | Graft Versus Host Disease;Aplastic Anemia | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: methylprednisolone;Procedure: Allogeneic Bone Marrow Transplantation | Northwestern Memorial Hospital | NULL | Active, not recruiting | 15 Years | 55 Years | Both | 3 | N/A | United States | |
| 10 | 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 |
| 11 | NCT00005852 (ClinicalTrials.gov) | June 1996 | 2/6/2000 | Bone Marrow Transplantation in Treating Patients With Severe Aplastic Anemia or Rejection of Previous Bone Marrow Transplant | Allogeneic Bone Marrow Transplantation for Marrow Failure States | Chronic Myeloproliferative Disorders;Graft Versus Host Disease;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes | Biological: anti-thymocyte globulin;Biological: filgrastim;Biological: muromonab-CD3;Drug: cyclophosphamide;Drug: cyclosporine;Drug: methylprednisolone;Procedure: allogeneic bone marrow transplantation | H. Lee Moffitt Cancer Center and Research Institute | National Cancer Institute (NCI) | Terminated | 15 Years | 55 Years | Both | Phase 2 | NULL | |
| 12 | NCT00002718 (ClinicalTrials.gov) | November 1995 | 1/11/1999 | T-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 Anemia | A 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 Donor | Leukemia;Lymphoma;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Neoplasms | Biological: 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 therapy | Memorial Sloan Kettering Cancer Center | National Cancer Institute (NCI) | Completed | N/A | 49 Years | Both | 31 | Phase 2 | United States |
| 13 | NCT00004323 (ClinicalTrials.gov) | February 1995 | 18/10/1999 | Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia | Aplastic Anemia | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: mesna;Drug: methotrexate;Drug: methylprednisolone | National Center for Research Resources (NCRR) | University of California, Los Angeles | Completed | N/A | 55 Years | Both | 10 | Phase 2 | United States |