Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation
RATIONALE: Some types of lymphoproliferative disease are associated with Epstein-Barr virus. Combining reduced immunosuppressive therapy with donor white blood cells that have been treated in the laboratory to kill cells infected with Epstein-Barr virus may be an effective treatment for lymphoproliferative disease.
PURPOSE: Randomized phase III trial to compare the effectiveness of reducing immunosuppressive therapy with or without donor white blood cells in treating patients who have Epstein-Barr virus-associated lymphoproliferative disease after organ transplantation.
Biological: therapeutic allogeneic lymphocytes
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients|
- Complete response
- Partial response
- Stable disease
- Progressive disease
- Time to complete remission
- Survival at 2 years
|Study Start Date:||March 2001|
- Determine the efficacy of treatment with partially HLA-matched allogeneic cytotoxic T cells and reduction of immunosuppression, in terms of survival rate and time to remission in patients with Epstein-Barr virus-associated B-cell lymphoproliferative disease after solid organ transplantation.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to transplanted organ type and transplant center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo sliding-scale reduction of immunosuppressive drugs from 1 of 5 regimens at physician's discretion. Patients then receive partially HLA-matched allogeneic cytotoxic T cells IV over 5 minutes once weekly for a total of 4 weeks.
- Arm II: Patients undergo reduction of immunosuppression as in arm I alone. Patients are followed monthly for 6 months and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033475
|Birmingham Children's Hospital|
|Birmingham, England, United Kingdom, B4 6NH|
|Cambridge, England, United Kingdom, CB3 8RE|
|Royal Free and University College Medical School|
|London, England, United Kingdom, NW3 2PF|
|King's College Hospital|
|London, England, United Kingdom, SE5 8RX|
|Manchester, England, United Kingdom, M23 9LJ|
|Central Manchester and Manchester Children's University Hospitals NHS Trust|
|Manchester, England, United Kingdom, M27 4HA|
|Northern General Hospital|
|Sheffield, England, United Kingdom, S5 7AU|
|Institute of Cancer Research - UK|
|Sutton, England, United Kingdom, SM2 5NG|
|Royal Infirmary of Edinburgh at Little France|
|Edinburgh, Scotland, United Kingdom, EH16 4SA|
|University of Edinburgh|
|Edinburgh, Scotland, United Kingdom, EH8 1QH|
|University of Edinburgh Laboratory for Clinical and Molecular Virology|
|Edinburgh, Scotland, United Kingdom, EH9 1QH|
|Royal Infirmary - Castle|
|Glasgow, Scotland, United Kingdom, G4 0SF|
|Study Chair:||Dorothy H. Crawford, MD||University of Edinburgh|