Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation
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|ClinicalTrials.gov Identifier: NCT00033475|
Recruitment Status : Unknown
Verified June 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
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 or disease||Intervention/treatment||Phase|
|Lymphoproliferative Disorder||Biological: therapeutic allogeneic lymphocytes||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Official Title:||Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients|
|Study Start Date :||March 2001|
- Complete response
- Partial response
- Stable disease
- Progressive disease
- Time to complete remission
- Survival at 2 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033475
|Birmingham Children's Hospital|
|Birmingham, England, United Kingdom, B4 6NH|
|Cambridge, England, United Kingdom, CB3 8RE|
|Royal Free and University College Medical School|
|London, England, United Kingdom, NW3 2PF|
|King's College Hospital|
|London, England, United Kingdom, SE5 8RX|
|Manchester, England, United Kingdom, M23 9LJ|
|Central Manchester and Manchester Children's University Hospitals NHS Trust|
|Manchester, England, United Kingdom, M27 4HA|
|Northern General Hospital|
|Sheffield, England, United Kingdom, S5 7AU|
|Institute of Cancer Research - UK|
|Sutton, England, United Kingdom, SM2 5NG|
|Royal Infirmary of Edinburgh at Little France|
|Edinburgh, Scotland, United Kingdom, EH16 4SA|
|University of Edinburgh|
|Edinburgh, Scotland, United Kingdom, EH8 1QH|
|University of Edinburgh Laboratory for Clinical and Molecular Virology|
|Edinburgh, Scotland, United Kingdom, EH9 1QH|
|Royal Infirmary - Castle|
|Glasgow, Scotland, United Kingdom, G4 0SF|
|Study Chair:||Dorothy H. Crawford, MD||University of Edinburgh|