EPOCH Chemotherapy Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Determination of safety profile and response rates
研究概览
简要总结
The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed setting. There is no standard treatment, and the few small studies that have been conducted have reported dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study include toxicity and response. Progression-free and overall survival will be measured. Tumors will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation, c-myc and EBV when possible.
详细描述
The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed setting. There is no standard treatment, and the few small studies that have been conducted have reported dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study include toxicity and response. Progression-free and overall survival will be measured. Tumors will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation, c-myc and EBV when possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
EPOCH-R every 3 weeks for up to 6 cycle
干预措施: Filgrastim (Biological)
1
EPOCH-R every 3 weeks for up to 6 cycle
干预措施: Rituximab (Biological)
1
EPOCH-R every 3 weeks for up to 6 cycle
干预措施: EPOCH (Drug)
结局指标
主要结局
Determination of safety profile and response rates
时间窗: End of Study
number and types of adverse events {AEs), as well as the number of patients who respond to the therapy {CR, PR, SD)
次要结局
未报告次要终点