Nonmyeloablative PBSC Allografting From HLA Matched Related Donors Using Fludarabine and/or Low Dose TBI With Disease-Risk Based Immunosuppression
I. To estimate the rate of grade III/IV graft-versus-host disease (GVHD) in patients treated
with low-dose total body irradiation (TBI), fludarabine (fludarabine phosphate), PBSC
infusion and immunosuppression with mycophenolate mofetil and a disease risk-based
II. To estimate the risk of graft rejection, GVHD, disease response, non-relapse mortality
and the incidence and severity of infectious complications using this treatment strategy.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
ARM I (indolent disease):
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4
to -2 and undergo TBI on day 0.
TRANSPLANTATION: Patients undergo donor peripheral blood stem cell transplantation (PBSCT)
on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) or IV every
8-12 hours on days -3 to 56 with a taper to day 180 and mycophenolate mofetil PO BID or IV
every 8-12 hours on days 0 to 27.
ARM II (aggressive disease):
CONDITIONING REGIMEN: Patients receive fludarabine phosphate and undergo TBI as in Arm I.
TRANSPLANTATION: Patients undergo donor PBSCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID or IV every 8-12 hours on days -3 to
56 with a taper to day 70 and mycophenolate mofetil as in Arm I.
After completion of study treatment, patients are followed up for 5 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Probability of severe (grade III/IV) GVHD in each arm
95% confidence interval will be calculated.
Assessed up to day 84
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Stanford University||Stanford, California 94305|
|LDS Hospital||Salt Lake City, Utah 84143|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|Baylor University Medical Center||Dallas, Texas 75246|
|City of Hope Medical Center||Duarte, California 91010|
|OHSU Knight Cancer Institute||Portland, Oregon 97239|
|University of Arizona||Tucson, Arizona 85724|
|University of Utah, Salt Lake City||Salt Lake City, Utah 84112|
|Froedtert Hospital||Milwaukee, Wisconsin 53226-3596|