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

Fecha de inicio: 1 de noviembre de 1996

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