A Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord Blood
I. The objective of this study is to determine the lowest dose of total body irradiation
combined with cyclophosphamide and antithymocyte globulin that will achieve sustained
engraftment in patients with severe aplastic anemia transplanted with unrelated umbilical
OUTLINE: This is a dose-escalation study of total-body irradiation (TBI).
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 to -4,
-6 to -3, or -5 to -2 and antithymocyte globulin IV on days -6 to -4, -5 to -3, or -4 to -2.
TBI: Patients undergo TBI twice daily on days -3, -2, and/or -1.
UMBILICAL CORD BLOOD TRANSPLANTATION (UCBT): Patients undergo UCBT on day 0. Patients
receive filgrastim (G-CSF) IV or subcutaneously beginning on day 1 and continuing until
blood counts recover.
GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive cyclosporine IV or orally (twice
daily for patients >= 6 years of age or 3 times daily for patients < 6 years of age) on days
-1 to +180 and mycophenolate mofetil IV or orally (twice daily for patients >= 50 kg or 3
times daily for patients < 50 kg) beginning 4 hours after UCBT and continuing until
approximately day +0.
After completion of study therapy, patients are followed periodically.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
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