Phase III Randomized Controlled Trial of Allogeneic Cytotoxic T-Cell Immunotherapy Following Reduction of Immunosuppression in Solid Organ Transplant Patients With Epstein-Barr Virus-Associated B-Cell Lymphoproliferative Disease
Last Modified: 5/21/2007 First Published: 4/1/2002
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Closed | Any age | CRUK-EBV-CTL
LCMV-CTL, EU-20057, NCT00033475 |
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.
Entry Criteria 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
Prior/Concurrent Therapy:
Biologic therapy: Chemotherapy: Endocrine therapy: Radiotherapy: Surgery: Other: - No prior therapy for PTLD
- No concurrent antiviral drugs (e.g., acyclovir or ganciclovir)
for PTLD
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: Hepatic: Renal: Other: Expected Enrollment 50A total of 50 patients will be accrued for this study. Outcomes Primary Outcome(s)Complete response
Partial response
Stable disease
Progressive disease
Time to complete remission
Survival at 2 years
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.
Trial Contact Information
Trial Lead Organizations University of Edinburgh Laboratory for Clinical and Molecular Virology  | | | | Dorothy Crawford, MD, Protocol chair | | | |
| Registry Information | | | Official Title | | Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients | | | Trial Start Date | | 2001-03-01 | | | Registered in ClinicalTrials.gov | | NCT00033475 1 | | | Date Submitted to PDQ | | 2002-02-05 | | | Information Last Verified | | 2002-06-14 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Table of Links
| 1 | http://clinicaltrials.gov/ct/show/NCT00033475 |
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