Non-Myeloablative Allogeneic Bone Marrow Transplant for Hematologic Malignancies
OBJECTIVES: I. Determine whether sustained engraftment of HLA identical sibling marrow can
be achieved in patients treated with total body irradiation before transplant and tacrolimus
and mycophenolate mofetil after transplant. II. Document the nonhematologic toxicities of
this regimen. III. Characterize immune reconstitution of patients during this treatment
regimen. IV. Document the incidence of aplasia and graft-versus-host disease associated with
donor leukocyte infusions when administered after this regimen.
OUTLINE: Patients receive total body irradiation in a single fraction on day -1. Tacrolimus
is given orally twice per day on days -1 to 50. Mycophenolate mofetil is given orally on day
0 and twice per day on days 1 to 28. Patients receive donor bone marrow infusion on day 0.
Patients are evaluated on days 56, 180, 292, and 365. If there is donor engraftment, donor
chimerism is less than 80%, there is no active graft-versus-host disease, no disease
progression, less than 50% decrease in donor cell chimerism from last measurement, and the
patient is not taking immunosuppressive agents, then donor leukocyte infusions are
administered on days 70, 194, and 306. Patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Primary Purpose: Treatment
Ephraim J. Fuchs, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Johns Hopkins Oncology Center||Baltimore, Maryland 21287|