Lymphoproliferative Disorder
Conditions
Keywords
post-transplant lymphoproliferative disorder
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 description
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.
Interventions
BIOLOGICALtherapeutic allogeneic lymphocytes
Sponsors
University of Edinburgh
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
0 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of post-transplant lymphoproliferative disease (PTLD) after solid organ (heart, heart/lung, liver, liver/gut, pancreas, or kidney) transplantation * Epstein-Barr virus-positive tumor * Newly diagnosed disease * Measurable disease by clinical methods or radiography * Must have partially matched donor cytotoxic T cells (CTL) available * No known panel reactivity to any of the HLA types of CTL available for therapy PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Karnofsky 20-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior therapy for PTLD * No concurrent antiviral drugs (e.g., acyclovir or ganciclovir) for PTLD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response | — |
| Partial response | — |
| Stable disease | — |
| Progressive disease | — |
| Time to complete remission | — |
| Survival at 2 years | — |
Countries
United Kingdom
Outcome results
None listed