Last updated on July 2015

Biological Therapy in Treating Patients at High-Risk or With Lymphoma Lymphoproliferative Disease or Malignancies


Brief description of study

RATIONALE: Some types of lymphoma or lymphoproliferative disease are associated with Epstein-Barr virus. White blood cells from donors who are immune to Epstein-Barr virus may be an effective treatment for those cancers. PURPOSE: This phase I/II trial is studying the side effects and best dose of biological therapy in treating patients at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.

Detailed Study Description

OBJECTIVES: - Determine the toxicity and therapeutic potential of adoptive immunotherapy with Epstein Barr virus (EBV)-specific cytotoxic T lymphocytes derived from HLA-histocompatible related donors or haplotype-matched donor in the treatment of patients at high-risk or with EBV-induced lymphomas and other lymphoproliferative diseases or malignancies in immunocompromised hosts. - Complete a single selected dose level phase II extension of this study to identify the probability of achieving a CR of EBV lymphoma with EBV-specific T-cell therapy in allogeneic HSCT recipients and immunodeficient patients. - Evaluate in vivo biodistribution, expansion, and duration of engraftment of successive doses of EBV-reactive lymphocytes within immunocompromised histocompatible hosts with EBV-associated lymphoproliferative diseases, and correlate these findings with the patients' T-cell populations, general immune status, and capacity to generate allospecific antidonor response. - Determine incidence, kinetics, and durability of pathologic and/or clinical responses in this patient population treatment with infusions of these EBV-specific T cells. OUTLINE: This is a dose-escalation study. Patients are stratified according to graft vs host disease risk (high vs low). Patients receive adoptive immunotherapy with allogeneic Epstein Barr virus (EBV)-specific cytotoxic T lymphocytes IV on days 1, 8, and 15. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. The dose of allogeneic EBV-specific cytotoxic T lymphocytes is escalated in cohorts of 3-6 patients until the maximum-tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed periodically for 1 year.

Clinical Study Identifier: NCT00002663

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Susan Prockop, MD

Memorial Sloan Kettering Cancer Center
New York, NY United States
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