Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia
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|ClinicalTrials.gov Identifier: NCT00004323|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Aplastic Anemia||Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cyclosporine Drug: mesna Drug: methotrexate Drug: methylprednisolone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||10 participants|
|Study Start Date :||February 1995|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|