Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia
OBJECTIVES: I. Evaluate the efficacy of related, HLA-identical bone marrow transplantation following cyclophosphamide (CTX) and antithymocyte globulin in patients with aplastic anemia.
II. Evaluate the efficacy of related, HLA-nonidentical bone marrow transplantation following CTX and total-body irradiation/total-lymphoid irradiation in patients with aplastic anemia.
|Aplastic Anemia||Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: mesna Drug: methotrexate Drug: methylprednisolone||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||February 1995|
PROTOCOL OUTLINE: Patients with HLA-identical donors receive cyclophosphamide/mesna, antithymocyte globulin (ATG), and methylprednisolone (MePRDL), followed by allogeneic marrow transplantation.
Patients with HLA-nonidentical (5/6 or 4/6) donors and those with a systemic reaction to ATG receive the same dosage of myeloablative chemotherapy and rescue. In addition, these patients are treated with total-body irradiation, total-lymphoid irradiation, and methotrexate.
All patients received MePRDL and cyclosporine for graft-versus-host prophylaxis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004323
|United States, California|
|Center for Health Sciences|
|Los Angeles, California, United States, 90024-1714|
|Study Chair:||Mary Carol Territo||University of California, Los Angeles|