Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002956
Status:
WITHDRAWN
Last Update Posted:
2016-03-21
First Post:
1999-11-01
Brief Title:
Immunotherapy for Lymphoproliferative Diseases Associated With Epstein-Barr Virus in Patients Who Have Undergone Organ Transplants
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Phase I Pilot Trial to Evaluate the Toxicity of Allogeneic Epstein-Barr Virus Specific T-Lymphocytes for the Treatment of EBV-Associated Lymphoproliferative Diseases in Organ Transplant Recipients
Status:
WITHDRAWN
Status Verified Date:
2012-11
Last Known Status:
None
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 Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help the body kill cancers associated with this virus
PURPOSE Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells derived from matched donors in organ transplant patients with lymphoproliferative diseases associated with Epstein-Barr virus
PURPOSE Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells derived from matched donors in organ transplant patients with lymphoproliferative diseases associated with Epstein-Barr virus
Detailed Description:
OBJECTIVES I Examine the toxic effects of allogeneic Epstein-Barr virus EBV specific cytotoxic T lymphocytes CTL for the treatment of EBV lymphoproliferative diseases LPD in organ transplant recipients II Determine the level of in vivo expansion of allogeneic CTL and the period of time during which these CTLs can be detected in the blood of recipients of the T cell infusions
OUTLINE Donors undergo leukapheresis and Epstein-Barr virus EBV specific cytoxic T lymphocytes are cultivated in vitro Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0 2 and 4 Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression
PROJECTED ACCRUAL 10 patients will be accrued in this study
OUTLINE Donors undergo leukapheresis and Epstein-Barr virus EBV specific cytoxic T lymphocytes are cultivated in vitro Patients receive infusions of EBV specific cytotoxic T lymphocytes over 5 to 10 minutes on weeks 0 2 and 4 Patients with stable disease and those achieving partial remission are followed weekly for signs of disease progression
PROJECTED ACCRUAL 10 patients will be accrued in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V97-1176 | None | None | None |
| UAB-9739 | None | None | None |
| IUMC-9611-37 | None | None | None |