Study of Allogeneic Bone Marrow Transplantation Using Matched, Related Donors in Patients With Nonmalignant Hematologic Disorders
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|ClinicalTrials.gov Identifier: NCT00005893|
Recruitment Status : Completed
First Posted : June 5, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Neutropenia Sickle Cell Anemia Thalassemia Major Red-Cell Aplasia, Pure||Drug: anti-thymocyte globulin Drug: busulfan Drug: cyclophosphamide Procedure: Bone marrow transplantation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||June 2000|
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): NCT00005893
|United States, Minnesota|
|Fairview University Medical Center|
|Minneapolis, Minnesota, United States, 55455|
|Study Chair:||Paul J. Orchard||Fairview University Medical Center|