Peripheral Stem Cell Transplantation Followed By Infusion of White Blood Cells in Treating Patients With AIDS-Related Lymphoma
RATIONALE: Donor peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Treatment with donor white blood cells may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of donor peripheral stem cell transplantation followed by infusions of donor white blood cells in treating patients who have AIDS-related lymphoma.
Biological: anti-thymocyte globulin
Biological: therapeutic allogeneic lymphocytes
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Delayed Donor Leukocyte Infusions in Patients Receiving Allogeneic PBSC Following Conditioning With Non-myeloablative Regimen for AIDS-Related Lymphoma (NHL and HD)|
|Study Start Date:||August 2001|
|Study Completion Date:||March 2003|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
- Determine the response rate of patients with AIDS-related lymphoma treated with allogeneic peripheral blood stem cell (PBSC) transplantation followed by delayed donor leukocyte infusion.
- 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 months thereafter.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3-4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024128
|Study Chair:||David T. Scadden, MD||Massachusetts General Hospital|