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| ID | Type | Description | Link |
|---|---|---|---|
| CRUK-EBV-CTL | |||
| LCMV-CTL | |||
| EU-20057 |
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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic allogeneic lymphocytes | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response | ||
| Partial response | ||
| Stable disease | ||
| Progressive disease | ||
| Time to complete remission | ||
| Survival at 2 years |
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DISEASE CHARACTERISTICS:
Diagnosis of post-transplant lymphoproliferative disease (PTLD) after solid organ (heart, heart/lung, liver, liver/gut, pancreas, or kidney) transplantation
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy H. Crawford, MD | University of Edinburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Children's Hospital | Birmingham | England | B4 6NH | United Kingdom | ||
| Papworth Hospital |
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| Cambridge |
| England |
| CB3 8RE |
| United Kingdom |
| Royal Free and University College Medical School | London | England | NW3 2PF | United Kingdom |
| King's College Hospital | London | England | SE5 8RX | United Kingdom |
| Wythenshawe Hospital | Manchester | England | M23 9LJ | United Kingdom |
| Central Manchester and Manchester Children's University Hospitals NHS Trust | Manchester | England | M27 4HA | United Kingdom |
| Northern General Hospital | Sheffield | England | S5 7AU | United Kingdom |
| Institute of Cancer Research - UK | Sutton | England | SM2 5NG | United Kingdom |
| Royal Infirmary of Edinburgh at Little France | Edinburgh | Scotland | EH16 4SA | United Kingdom |
| University of Edinburgh | Edinburgh | Scotland | EH8 1QH | United Kingdom |
| University of Edinburgh Laboratory for Clinical and Molecular Virology | Edinburgh | Scotland | EH9 1QH | United Kingdom |
| Royal Infirmary - Castle | Glasgow | Scotland | G4 0SF | United Kingdom |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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