Allogeneic Hematopoietic Stem Cell Transplantation With Nonmyeloablative Conditioning for Patients With Chronic Lymphocytic Leukemia - a Multi-Center Trial
I. To determine whether nonmyeloablative allogeneic hematopoietic stem cell transplantation
(HSCT) from matched-related donors can improve the probability of survival 18 months after
treatment for fludarabine (fludarabine phosphate)-refractory, fludarabine phosphate,
cyclophosphamide, and rituximab (FCR)-failed, or del 17p chronic lymphocytic leukemia (CLL)
beyond that observed in historical controls (30%).
I. To assess the rate of relapse with allogeneic HSCT using nonmyeloablative conditioning
for patients with fludarabine-refractory, FCR-failed, or del 17p CLL compared with
historical data on autologous HSCT.
II. To estimate the incidence of grade 2-4 acute graft-versus-host disease (GVHD) and
chronic GVHD in patients with CLL treated with low-dose TBI, fludarabine, PBSC infusion and
immunosuppression with cyclosporine and mycophenylate mofetil.
III. To characterize the rate and types of infections with this regimen. IV. To estimate the
rate of transplant-related mortality in the first 200 days.
NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) on
days -4 to -2 and TBI on day 0.
TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclosporine orally (PO) every 12 hours on days -3 to 180
with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.
After completion of study treatment, patients are followed up at 12 and 18 months, and then
annually thereafter for 5 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival using a non-myeloablative conditioning regimen with HSCT in patients with fludarabine phosphate-refractory CLL
At 18 months
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|Veterans Administration Center-Seattle||Seattle, Washington 98108|