283. 後天性赤芽球癆 Acquired pure red cell aplasia Clinical trials / Disease details
臨床試験数 : 18 / 薬物数 : 42 - (DrugBank : 22) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 98
| 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 | NCT04965597 (ClinicalTrials.gov) | March 2022 | 21/6/2021 | Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904) | Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure Diseases | Bone Marrow Failure Syndrome;Congenital Amegakaryocytic Thrombocytopenia;Congenital Pure Red Cell Aplasia;Hereditary Sideroblastic Anemia;Myeloid Neoplasms With Germline GATA2 Mutation;Paroxysmal Nocturnal Hemoglobinuria;Shwachman-Diamond Syndrome | Drug: Treosulfan;Drug: Fludarabine Phosphate;Drug: Tacrolimus;Drug: Methotrexate;Biological: Lapine T-Lymphocyte Immune Globulin;Procedure: Peripheral Blood Stem Cell Transplantation;Procedure: Allogeneic Bone Marrow Transplantation;Other: Quality-of-Life Assessment | Fred Hutchinson Cancer Research Center | Blood and Marrow Transplant Clinical Trials Network;National Cancer Institute (NCI);National Marrow Donor Program;National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 1 Year | 49 Years | All | 40 | Phase 2 | United States |
| 2 | NCT04423367 (ClinicalTrials.gov) | September 13, 2020 | 5/6/2020 | Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment | Safety and Efficacy of Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment: A Prospective Phase II Trial | Acquired Pure Red Cell Aplasia | Drug: bortezomib/dexamethasone | Institute of Hematology & Blood Diseases Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 17 | Phase 2 | China |
| 3 | NCT04470804 (ClinicalTrials.gov) | August 1, 2020 | 9/7/2020 | Sirolimus Treatment for Newly Diagnosed Primary Acquired PRCA | Sirolimus Treatment for Newly Diagnosed Primary Acquired Pure Red Cell Aplasia: a Single Center Prospective Study | Pure Red Cell Aplasia, Acquired | Drug: Sirolimus;Drug: Cyclosporine A | Bing Han | NULL | Recruiting | 18 Years | 70 Years | All | 40 | Phase 4 | China |
| 4 | NCT03966053 (ClinicalTrials.gov) | September 13, 2019 | 23/5/2019 | The Use of Trifluoperazine in Transfusion Dependent DBA | Phase I/II, Open Label Study to Determine Safety of Trifluoperazine (TFP) in Adults With Red Blood Cell Transfusion-Dependent Diamond Blackfan Anemia | Diamond Blackfan Anemia;Pure Red Cell Aplasia | Drug: Trifluoperazine | Adrianna Vlachos | NULL | Terminated | 18 Years | 65 Years | All | 2 | Phase 1/Phase 2 | United States |
| 5 | NCT03918265 (ClinicalTrials.gov) | May 4, 2019 | 16/4/2019 | Tacrolimus Treatment for Refractory Autoimmune Cytopenia | Tacrolimus Treatment for Refractory Autoimmune Cytopenia | Autoimmune Hemolytic Anemia;Pure Red Cell Aplasia;Evans Syndrome | Drug: Tacrolimus | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 80 | Phase 4 | China |
| 6 | NCT03540472 (ClinicalTrials.gov) | June 10, 2018 | 14/5/2018 | Tacrolimus Treatment for Refractory PRCA | Tacrolimus Treatment for Refractory Pure Red Cell Aplasia, a Prospective Study | Pure Red Cell Aplasia | Drug: tacrolimus | Peking Union Medical College Hospital | NULL | Unknown status | 18 Years | 80 Years | All | 30 | Phase 4 | China |
| 7 | NCT03364764 (ClinicalTrials.gov) | February 1, 2018 | 21/11/2017 | Sirolimus Treatment for Refractory PRCA | Sirolimus Treatment for Refractory Pure Red Cell Aplasia, a Prospective Study | Pure Red Cell Aplasia | Drug: Sirolimus | Bing Han | NULL | Completed | 18 Years | 80 Years | All | 64 | Phase 4 | China |
| 8 | NCT03333486 (ClinicalTrials.gov) | December 7, 2017 | 2/11/2017 | Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer | A Phase II Trial of Haploidentical Allogeneic Stem Cell Transplantation Utilizing Mobilized Peripheral Blood Stem Cells | Accelerated 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 Syndrome | Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Procedure: Peripheral Blood Stem Cell Transplantation;Radiation: Total-Body Irradiation | Roswell Park Cancer Institute | NULL | Recruiting | 1 Year | 75 Years | All | 58 | Phase 2 | United States |
| 9 | NCT03214354 (ClinicalTrials.gov) | July 5, 2017 | 5/7/2017 | Nonmyeloablative Stem Cell Transplant in Children With Sickle Cell Disease and a Major ABO-Incompatible Matched Sibling Donor | A Phase II Pilot Study of Nonmyeloablative Conditioning Hematopoietic Stem Cell Transplantation in Children With Sickle Cell Disease Who Have a Matched Related Major ABO-Incompatible Donor (Sickle-AID) | Sickle Cell Disease;Stem Cell Transplant Complications;Red Blood Cell Disorder;Pure Red Cell Aplasia | Drug: Alemtuzumab;Radiation: Total Body Irradiation;Drug: Sirolimus | University of Calgary | NULL | Recruiting | 1 Year | 19 Years | All | 12 | Phase 2 | Canada |
| 10 | NCT01362595 (ClinicalTrials.gov) | June 2013 | 20/5/2011 | Pilot Phase I/II Study of Amino Acid Leucine in Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia | The Use of Novel Therapies to Reconstitute Blood Cell Production and Promote Organ Performance Using Bone Marrow Failure as a Model: a Pilot, Phase I/II Study of the Amino Acid Leucine in the Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia | Diamond Blackfan Anemia;Blackfan Diamond Syndrome;DBA;Congenital Hypoplastic Anemia;Pure Red Cell Aplasia | Drug: leucine | Northwell Health | NULL | Active, not recruiting | 2 Years | N/A | All | 50 | Phase 1/Phase 2 | United States |
| 11 | NCT01288131 (ClinicalTrials.gov) | January 2009 | 1/2/2011 | Study of Anti-r-HuEpo Associated Pure Red Cell Aplasia (PRCA) Treatment | Randomized Controlled Trial Study of Anti-r-HuEpo Associated PRCA Treated by Cyclosporine and Mycophenolate Mofetil (MMF) Compared With Cyclophosphamide and Prednisolone | Anti-r-HuEpo Associated PRCA Subjects | Drug: Cyclosporine combine with mycophenolate mofetil;Drug: Cyclophosphamide + pred | Chulalongkorn University | NULL | Terminated | 18 Years | 60 Years | Both | 8 | Phase 3 | Thailand |
| 12 | NCT00314795 (ClinicalTrials.gov) | April 6, 2006 | 13/4/2006 | Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease | An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients With Chronic Kidney Disease | Anemia;Chronic Kidney Disease;Chronic Renal Failure;Pure Red Cell Aplasia | Drug: Peginesatide | Takeda | NULL | Completed | 18 Years | N/A | All | 22 | Phase 2 | France;Germany;United Kingdom |
| 13 | EUCTR2005-004944-30-DE (EUCTR) | 08/03/2006 | 20/12/2005 | A Phase 2 study of AF37702 Injection for anemia in patients with pure red cell aplasia. | An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection (Hematide™) in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease - AFX01-06 | Anemia caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease MedDRA version: 18.0;Level: PT;Classification code 10002965;Term: Aplasia pure red cell;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: AF37702 Injection Product Code: AF37702, Hematide INN or Proposed INN: peginesatide Other descriptive name: Hematide, peginesatide Product Name: AF37702 Injection Product Code: AF37702, Hematide INN or Proposed INN: peginesatide Other descriptive name: Hematide, peginesatide | Takeda Development Centre Europe Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Germany;United Kingdom | ||
| 14 | EUCTR2005-004944-30-GB (EUCTR) | 23/02/2006 | 09/12/2005 | A Phase 2 study of AF37702 Injection for anemia in patients with pure red cell aplasia. | An Open-Label Study to Investigate the Efficacy and Safety of AF37702 Injection in the Treatment of Anemia Caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease - AFX01-06 | Anemia caused by Antibody-Mediated Pure Red Cell Aplasia in Patients with Chronic Kidney Disease MedDRA version: 18.0;Level: PT;Classification code 10002965;Term: Aplasia pure red cell;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: AF37702 Injection Product Code: AF37702, Hematide INN or Proposed INN: peginesatide Other descriptive name: Hematide, peginesatide Product Name: AF37702 Injection Product Code: AF37702, Hematide INN or Proposed INN: peginesatide Other descriptive name: Hematide, peginesatide | Takeda Development Centre Europe Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Germany;United Kingdom | ||
| 15 | NCT00229619 (ClinicalTrials.gov) | September 2005 | 29/9/2005 | Rituximab to Treat Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia | A 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 Anemia | Anemia, Aplastic;Red-Cell Aplasia, Pure;Anemia, Diamond-Blackfan | Drug: Rituximab | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 2 Years | N/A | All | 11 | Phase 2 | United States |
| 16 | NCT00006055 (ClinicalTrials.gov) | March 2000 | 5/7/2000 | Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases | Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation | Fairview University Medical Center | NULL | Active, not recruiting | 1 Year | 55 Years | Both | 10 | N/A | United States | |
| 17 | NCT00001962 (ClinicalTrials.gov) | November 1999 | 18/1/2000 | A Study to Determine Whether Therapy With Daclizumab Will Benefit Patients With Bone Marrow Failure | A 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 Anemia | Aplastic Anemia;Pure Red Cell Aplasia;Diamond Blackfan Anemia | Drug: Daclizumab | Neal Young, M.D. | NULL | Terminated | 2 Years | N/A | All | 100 | Phase 2 | United States |
| 18 | NCT00004143 (ClinicalTrials.gov) | September 1999 | 10/12/1999 | Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes | Allogeneic Mixed Chimerism Stem Cell Transplantation Utilizing In Vivo and In Vitro Campath for Hemoglobinopathies and Bone Marrow Failure Syndromes | Sickle Cell Anemia;Severe Aplastic Anemia;Paroxysmal Nocturnal Hemoglobinuria (PNH);Pure Red Cell Aplasia | Drug: Campath, Chemo and/or TBI Allo SCT | David Rizzieri, MD | NULL | Completed | 18 Years | N/A | All | 2 | Phase 2 | United States |