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Sponsored by: |
University of Edinburgh |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033475 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoproliferative Disorder |
Drug: therapeutic allogeneic lymphocytes |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients |
Estimated Enrollment: | 50 |
Study Start Date: | March 2001 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of post-transplant lymphoproliferative disease (PTLD) after solid organ (heart, heart/lung, liver, liver/gut, pancreas, or kidney) transplantation
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United Kingdom, England | |
Birmingham Children's Hospital | |
Birmingham, England, United Kingdom, B4 6NH | |
Central Manchester and Manchester Children's University Hospitals NHS Trust | |
Manchester, England, United Kingdom, M27 4HA | |
Institute of Cancer Research - UK | |
Sutton, England, United Kingdom, SM2 5NG | |
Papworth Hospital | |
Cambridge, England, United Kingdom, CB3 8RE | |
Northern General Hospital | |
Sheffield, England, United Kingdom, S5 7AU | |
King's College Hospital | |
London, England, United Kingdom, SE5 8RX | |
Royal Free and University College Medical School | |
London, England, United Kingdom, NW3 2PF | |
Wythenshawe Hospital | |
Manchester, England, United Kingdom, M23 9LJ | |
United Kingdom, Scotland | |
Royal Infirmary - Castle | |
Glasgow, Scotland, United Kingdom, G4 0SF | |
Royal Infirmary of Edinburgh at Little France | |
Edinburgh, Scotland, United Kingdom, EH16 4SA | |
University of Edinburgh Laboratory for Clinical and Molecular Virology | |
Edinburgh, Scotland, United Kingdom, EH9 1QH | |
University of Edinburgh | |
Edinburgh, Scotland, United Kingdom, EH8 1QH |
Study Chair: | Dorothy H. Crawford, MD | University of Edinburgh |
Study ID Numbers: | CDR0000069288, CRUK-EBV-CTL, LCMV-CTL, EU-20057 |
Study First Received: | April 9, 2002 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00033475 |
Health Authority: | United States: Federal Government |
post-transplant lymphoproliferative disorder |
Post-transplant lymphoproliferative disease Lymphatic Diseases Immunoproliferative Disorders Lymphoproliferative Disorders |
Immune System Diseases |