Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation
NCT ID: NCT00033475
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2001-03-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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therapeutic allogeneic lymphocytes
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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University of Edinburgh
OTHER
Principal Investigators
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Dorothy H. Crawford, MD
Role: STUDY_CHAIR
University of Edinburgh
Locations
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Birmingham Children's Hospital
Birmingham, England, United Kingdom
Papworth Hospital
Cambridge, England, United Kingdom
Royal Free and University College Medical School
London, England, United Kingdom
King's College Hospital
London, England, United Kingdom
Wythenshawe Hospital
Manchester, England, United Kingdom
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom
Northern General Hospital
Sheffield, England, United Kingdom
Institute of Cancer Research - UK
Sutton, England, United Kingdom
Royal Infirmary of Edinburgh at Little France
Edinburgh, Scotland, United Kingdom
University of Edinburgh
Edinburgh, Scotland, United Kingdom
University of Edinburgh Laboratory for Clinical and Molecular Virology
Edinburgh, Scotland, United Kingdom
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom
Countries
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Other Identifiers
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CRUK-EBV-CTL
Identifier Type: -
Identifier Source: secondary_id
LCMV-CTL
Identifier Type: -
Identifier Source: secondary_id
EU-20057
Identifier Type: -
Identifier Source: secondary_id
CDR0000069288
Identifier Type: -
Identifier Source: org_study_id