Low-Dose Allogeneic Peripheral Blood Stem Cell Transplantation for High-Risk Low Grade Hematologic Malignancies
- Determine the safety of non-myeloablative allogeneic peripheral blood stem cell
transplantation, in terms of regimen-related organ toxicity and toxicity from acute
graft-vs-host disease (GVHD), in older or medically frail patients with high-risk
indolent hematologic malignancies.
- Determine overall survival, disease-free survival, and relapse risk at 1, 2, and 3
years post-transplantation in these patients.
- Determine the engraftment of donor hematopoiesis at 6 weeks, 3 and 6 months, and 1 year
post-transplantation in these patients.
- Determine the incidence and severity of chronic GVHD in older and medically infirm
patients treated with this regimen.
- Determine the safety and efficacy of collecting peripheral blood stem cells from older
donors (age > 60 years).
- Determine the need and efficacy of donor lymphocyte infusions in patients with residual
disease after transplant.
- Non-myeloablative preparative regimen:Patients receive fludarabine IV over 30 minutes
on days -7 to -3, busulfan IV over 2 hours every 8 hours on days -4 and -3, and
anti-thymocyte globulin IV over 8 hours on days -4 to -1.
- Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation
on day 0. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 6 and
continuing until blood counts recover.
- Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus orally every 12
hours or IV continuously beginning on day -2 and continuing until day 90, followed by a
taper until day 180. Patients also receive methotrexate IV over 15-30 minutes on days
1, 3, 6, and 11.
- Donor lymphocyte infusions (DLIs): Patients with residual disease ≥ 6 months
post-transplantation who are off immunosuppression for ≥ 30 days with no evidence of
GVHD may receive DLIs. DLIs are administered ≥ 12 weeks apart in the presence of
persistent disease, absence of severe (grade 3-4) GVHD, and absence of persistent GVHD
after the first DLI.
After completion of study therapy, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity and survival
up to 36 months post transplant
Thomas G. Martin, MD
University of California, San Francisco
United States: Federal Government
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|
|Alta Bates Comprehensive Cancer Center||Berkeley, California 94704|