Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation From HLA Matched Related Donors for Treatment of Older Patients With De Novo or Secondary Acute Myeloid Leukemia in First Complete Remission
I. To determine if a one-year disease free survival of >= 35% can be achieved among patients
>= 55 years old with de novo and secondary AML in first complete remission (CR1) who undergo
nonmyeloablative hematopoietic stem cell transplant (HSCT) from human leukocyte antigen
(HLA) identical related donors.
II. To determine if a day +200 nonrelapse related mortality of < 15% can be achieved among
patients >= 55 years old with de novo and secondary AML in CR1 who undergo nonmyeloablative
HSCT from HLA identical related donors.
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4
to -2 and undergo TBI on day 0.
TRANSPLANT: Patients undergo allogeneic PBSC transplant on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine (CSP) orally (PO) twice daily (BID) on days
-3 to 56 with taper to day 77. Patients also receive mycophenolate mofetil (MMF) PO BID on
After completion of study treatment, patients are followed up on days 28, 56, and 84; months
6, 12, 18, and 24; and then yearly for 5 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival-incidence of survival without relapse
Sufficient evidence will be taken to be an observed rate of DFS at one year after transplant that corresponds to a one-sided 95% confidence interval with an upper limit lower than 35%.
By 1 year after transplant
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|OHSU Cancer Institute||Portland, Oregon 97239|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|