Lymphoproliferative Disorder Clinical Trial
Official title:
Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients
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.
OBJECTIVES:
- 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.
;
Allocation: Randomized, Primary Purpose: Treatment
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