Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation
This trial is active, not recruiting.
|Treatment||therapeutic allogeneic lymphocytes|
|Sponsor||University of Edinburgh|
|Start date||March 2001|
|Trial size||50 participants|
|Trial identifier||NCT00033475, CDR0000069288, CRUK-EBV-CTL, EU-20057, LCMV-CTL|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, United Kingdom||Birmingham Children's Hospital||no longer recruiting|
|Cambridge, United Kingdom||Papworth Hospital||no longer recruiting|
|London, United Kingdom||Royal Free and University College Medical School||no longer recruiting|
|London, United Kingdom||King's College Hospital||no longer recruiting|
|Manchester, United Kingdom||Central Manchester and Manchester Children's University Hospitals NHS Trust||no longer recruiting|
|Manchester, United Kingdom||Wythenshawe Hospital||no longer recruiting|
|Sheffield, United Kingdom||Northern General Hospital||no longer recruiting|
|Sutton, United Kingdom||Institute of Cancer Research - UK||no longer recruiting|
|Edinburgh, United Kingdom||University of Edinburgh||no longer recruiting|
|Edinburgh, United Kingdom||Royal Infirmary of Edinburgh at Little France||no longer recruiting|
|Edinburgh, United Kingdom||University of Edinburgh Laboratory for Clinical and Molecular Virology||no longer recruiting|
|Glasgow, United Kingdom||Royal Infirmary - Castle||no longer recruiting|
Time to complete remission
Survival at 2 years
Male or female participants of any age.
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
|Official title||Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients|
|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.|
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