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
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean length of time of allogeneic CTL during which these CTL's can be detected in the blood of recipients of the T cell infusions.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- 未提供
研究组 & 干预措施
infusions of EBV specific cytotoxic T lymphocytes
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
干预措施: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes (Biological)
结局指标
主要结局
Mean length of time of allogeneic CTL during which these CTL's can be detected in the blood of recipients of the T cell infusions.
时间窗: baseline to x weeks past infusion
Number of adverse events associated with administration of allogeneic Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTL) for the treatment of EBV lymphoproliferative diseases (LPD) in organ transplant recipients
时间窗: baseline to x weeks post infusion
次要结局
未报告次要终点