NCT00568815已完成2 期
Phase II Study of Rituximab Combined With ESHAP in Patients With Relapse or Refractory DLBCL
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse large B cell lymphoma (DLBCL).
详细描述
The salvage therapy in the patients with DLBCL is still controversial. The investigators conducted this study to evaluate the efficacy and tolerability of Rituximab combined with ESHAP in the patients with DLBCL. The patients enrolled were defined to be relapsed or refractory after the first-line chemotherapy like CHOP or other CHOP-like regimens.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range 18-70 years old
- •Histological confirmed diffuse large B cell lymphoma
- •ECOG performance status no more than 2
- •Life expectancy of more than 3 months
- •Relapse or refractory after the first-line chemotherapy of DLBCL
- •No evidence of bone marrow involvement
- •Normal laboratory values: hemoglobin > 8.0g/dl, neutrophil > 1.5×109/L, platelet > 80×109/L, serum creatine < 1× upper limitation of normal(ULN), serum bilirubin < 1× ULN, ALT and AST < 1.5× ULN
排除标准
- •Pregnant or lactating women
- •Serious uncontrolled diseases and intercurrent infection
- •The evidence of CNS metastasis and bone marrow involvement
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •History of allergic reaction/hypersensitivity to rituximab
研究组 & 干预措施
Chemo
Experimental
干预措施: Rituximab combined with ESHAP (Drug)
结局指标
主要结局
Response rate
时间窗: 6 weeks
次要结局
- Toxicities(every cycle)
研究者
研究点 (1)
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