OBJECTIVES: I. Compare outcome, including graft failure, graft versus host disease, and survival of HLA-identical sibling bone marrow transplants for aplastic anemia using cyclophosphamide with or without antithymocyte globulin as a conditioning regimen.
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive cyclophosphamide IV over 60 minutes on days -5 to -2 with or without antithymocyte globulin IV over 4 hours. All patients then receive bone marrow over 60-120 minutes on day 0, 36 hours after the last dose of cyclophosphamide. Patients are followed at day 100, at 6 months, and at 1 year posttransplant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
224
Given via IV over 4 hours
Given via IV over 60 minutes on Days -5 to -2
Given on Day 0
Roswell Park Cancer Institute
Buffalo, New York, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Graft failure, graft versus host disease, and survival
Time frame: Measured at Day 100, Month 6, and Year 1 post-transplant
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