Expired Study
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Chicago, Illinois 60611


Purpose:

RATIONALE: Peripheral blood lymphocyte therapy may be effective in the treatment and prevention of Epstein-Barr virus infection following transplantation. PURPOSE: Phase II trial to study the effectiveness of peripheral blood lymphocyte therapy in treating and preventing lymphoproliferative disorders in patients who have Epstein-Barr virus infection following transplantation.


Study summary:

OBJECTIVES: - Compare the efficacy of Epstein Barr virus (EBV) reactive autologous and allogeneic lymphocyte clones ex vivo in targeting EBV immortalized lymphoblasts in patients undergoing a solid organ transplant or T cell depleted bone marrow transplant. - Determine the efficacy of these regimens as treatment and prophylaxis in those patients who develop EBV viremia or EBV induced lymphoproliferative disease. OUTLINE: Autologous and allogeneic Epstein Barr virus (EBV) reactive lymphocytes are isolated from patients and siblings and tested in vitro for cytotoxic activity. Patients who develop EBV viremia or EBV related lymphoproliferative disease after transplant receive autologous Epstein Barr virus (EBV) reactive lymphocytes IV over 20 minutes. Patients receive allogeneic EBV reactive lymphocytes if autologous lymphocytes fail to control EBV proliferation or when sufficient autologous reactive lymphocytes cannot be isolated. Treatment repeats every 4 weeks in the presence of EBV viremia or lymphoproliferative disease. After 5 patients have received therapy without unacceptable toxicity, patients may receive lymphocytes as prophylactic therapy. Patients are followed at 4 weeks, 8 weeks, 6 months, and 12 months. PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Patients who have received or will receive a solid organ transplant or T cell depleted bone marrow transplant - Epstein Barr virus (EBV) DNA detectable and seronegative OR - EBV seropositive - Fully matched or one HLA antigen mismatched sibling donor - HIV negative - Hepatitis B surface antigen negative - Hepatitis C antibody negative - No older than 65 years - No prior primary malignancy within the past 5 years in donor except previously resected skin cancer PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00005606


Primary Contact:

Study Chair
Ann Traynor, MD
Robert H. Lurie Cancer Center


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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