Study of Allogeneic Bone Marrow Transplantation Using Matched, Related Donors in Patients With Nonmalignant Hematologic Disorders
OBJECTIVES: I. Determine the efficacy of bone marrow transplantation using matched related donors in patients with nonmalignant hematologic disorders.
II. Determine the quality of life, absence of adverse effects (e.g., graft versus host disease and B cell lymphoproliferative disease), and completeness of recovery of their underlying condition in these patients with this treatment regimen.
|Neutropenia Sickle Cell Anemia Thalassemia Major Red-Cell Aplasia, Pure||Drug: anti-thymocyte globulin Drug: busulfan Drug: cyclophosphamide Procedure: Bone marrow transplantation|
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||June 2000|
PROTOCOL OUTLINE: Patients receive IV or oral busulfan every 6 hours on days -9 to -6; cyclophosphamide IV on days -5 to -2; anti-thymocyte globulin IV on days -4 to -2; and allogeneic bone marrow transplantation (BMT) on day 0.
Patients with class 3 thalassemia (liver edge greater than 2 cm below costal margin, a history of inconsistent chelation, and portal fibrosis) receive a less intensive conditioning regimen consisting of oral busulfan every 6 hours on days -7 to -4; anti-thymocyte globulin IV on days -5 to -1 and days 1-5; cyclophosphamide IV on days -3 to -2; and allogeneic BMT on day 0.
Patients are followed at day 28, and then at 3, 6, 12, and 24 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005893
|United States, Minnesota|
|Fairview University Medical Center|
|Minneapolis, Minnesota, United States, 55455|
|Study Chair:||Paul J. Orchard||Fairview University Medical Center|