Delayed Donor Leukocyte Infusions in Patients Receiving Allogeneic PBSC Following Conditioning With Non-myeloablative Regimen for AIDS-Related Lymphoma (NHL and HD)
- Determine the response rate of patients with AIDS-related lymphoma treated with
allogeneic peripheral blood stem cell (PBSC) transplantation followed by delayed donor
- Determine the complication rate of these patients treated with PBSC transplantation.
- Determine the immune dysfunction and recovery of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV over 60 minutes on days -5 to -3. Patients who have not
received prior mediastinal radiotherapy receive thymic radiotherapy on day -1. Allogeneic
peripheral blood stem cells are infused on day 0. Patients also receive anti-thymocyte
globulin IV over 10-12 hours on days -1, 1, 3, and 5 and cyclosporine IV beginning on day
-1, switching to oral when possible, and tapering until day 35.
In the absence of active acute graft-versus-host disease (GVHD), and at least 2 weeks after
completion of cyclosporine, patients receive an infusion of donor leukocytes on or before
day 49. Patients may receive a second donor leukocyte infusion if there is evidence of
persistent malignancy and no GVHD.
Patients are followed through day 100, on days 120, 180, 270, and 365, and then every 6
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3-4
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
David T. Scadden, MD
Massachusetts General Hospital
United States: Federal Government