Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033475
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2002-04-09
Brief Title:
Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation
Sponsor:
University of Edinburgh
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease Randomized Controlled Trial in Transplant Recipients
Status:
UNKNOWN
Status Verified Date:
2002-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
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
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 physicians 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
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 physicians 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20057 | None | None | None |
| CRUK-EBV-CTL | None | None | None |
| LCMV-CTL | None | None | None |