Phase III Randomized Study of Cyclophosphamide With or Without Antithymocyte Globulin Before Bone Marrow Transplantation in Patients With Aplastic Anemia
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Graft failure, graft versus host disease, and survival
Measured at Day 100, Month 6, and Year 1 post-transplant
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Midwest Children's Cancer Center||Milwaukee, Wisconsin 53226|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|