Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Birmingham, Alabama 35294


Purpose:

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.


Study summary:

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 CTL's 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.


Criteria:

Inclusion criteria: - Radiographic evidence of lymphadenopathy or lymphomatous lesions combined with clinical signs of Epstein-Barr virus lymphoproliferative disease (EBV LPD), such as fevers and lymphadenopathy - following an organ transplant Persistent, progressive, or unresponsive disease despite decreased immunosuppression, chemotherapy, or radiation therapy EBV LPD must be of host origin - At least 4 weeks - Patients serologically hepatitis B and C positive may receive cytotoxic - T- lymphocytes (CTL) from donors who are serologically positive for the same virus - Must have an HLA identical or HLA haploidentical donor Exclusion - hepatic dysfunction SGOT/SGPT less than 2.5 times upper limit of normal (unless liver metastases present) - Bilirubin less than 2.0 mg/dL - renal dysfunction - Creatinine clearance at greater than 50 mL/min - cardiac dysfunction - neurologic dysfunction - pulmonary dysfunction - patients developing EBV LPD who have a donor origin lymphoma - HIV-1 positive - Not capable of undergoing leukapheresis


NCT ID:

NCT00002956


Primary Contact:

Study Chair
Kenneth G. Lucas, MD
University of Alabama at Birmingham


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35294
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.