NCT00367497终止2 期
Phase 2 Study of Rituximab and ESHAP (Etoposide, Methylprednisolone, Cytarabine, and Cisplatin) in Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Overall response
研究概览
简要总结
Aggressive non-Hodgkin's lymphoma is difficult to handle once it relapses or becomes refractory to chemotherapy. Various second or third line chemotherapies, which are called salvage chemotherapy, were developed without promising results. Improvement in efficacy by adding relatively new agent, rituximab, to chemotherapy is now widely accepted in non-Hodgkin's lymphoma. This study will test the safety and efficacy of adding rituximab to existing salvage chemotherapy, ESHAP (R-ESHAP). Our aim is also to proceed to high-dose chemotherapy with autologous hematopoietic stem cell transplantation after successful R-ESHAP therapy.
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
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of aggressive non-Hodgkin's lymphoma
- •Refractory to the first line chemotherapy or relapsed
- •Expression of CD20 on lymphoma cells
- •Measurable lesions on imaging studies
排除标准
- •Blood cell counts not reaching to 3,000/microliter for white blood cells, 7 g/dl for hemoglobin, and 50,000/microliter for platelets without transfusion at the time of registration
- •Circulating lymphoma cells equal to or more than 25,000/microliter
- •Hepatic dysfunction
- •Renal insufficiency
- •Cardiac dysfunction or arrhythmia
- •Sever infection (bacterial, viral)
- •CNS involvement
- •Other malignancies
- •Pregnancy or breast feeding
结局指标
主要结局
Overall response
次要结局
- Complete response
- Safety
- Overall survival
- Progression free survival
- Effectiveness of peripheral blood stem cell collection
研究者
研究点 (2)
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