Cyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia: Effect of Marrow Cell Dose on Chronic Graft-vs.-Host Disease: A Multi-Center Trial
I. Minimize the incidence of chronic GVHD by restricting the transplanted marrow dose to
2.0-2.5 x 10^8 nucleated cells/kg.
I. Engraftment and overall survival.
CONDITIONING REGIMEN: Patients receive cyclophosphamide intravenously (IV) on days -5 to -2
and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2.
TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive methotrexate IV on days 1, 3, 6, and 11 and cyclosporine
IV over 1 hour or orally (PO) twice daily on days -1 to 50, followed by a taper until 6
months after grafting.
After completion of study treatment, patients are followed up at on day 180, 1 year, 1.5
years, 2 years, 3 years, and yearly thereafter.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of chronic GVHD
Analyzed using cumulative incidence estimates, treating death or rejection as competing risk events. Confidence intervals will be calculated using the method described by Marubini and Valsecchi (1995). Risk factors for the development of chronic GVHD will be evaluated using Cox regression analyses methods.
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|Huntsman Cancer Institute/University of Utah||Salt Lake City, Utah 84112|
|Froedtert and the Medical College of Wisconsin||Milwaukee, Wisconsin 53226|