Lymphoma Clinical Trial
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
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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