Clinical Trial: Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: University of Edinburgh
Current Primary Outcome:
- Complete response
- Partial response
- Stable disease
- Progressive disease
- Time to complete remission
- Survival at 2 years
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: April 9, 2002
Date Started: March 2001
Date Completion:
Last Updated: December 18, 2013
Last Verified: June 2002