Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients
- 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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Dorothy H. Crawford, MD
University of Edinburgh
United States: Federal Government