Non Hodgkin Lymphoma Clinical Trial
Immunotherapy for Lymphoproliferative Diseases Associated With Epstein-Barr Virus in Patients Who Have Undergone Organ Transplants
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.
Full 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 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.
Eligibility 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
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There is 1 Location for this study
Birmingham Alabama, 35294, United States
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