Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of California, San Francisco
With
OBJECTIVES: Primary * 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. Secondary * 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. OUTLINE: * 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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
