NCT04438005已完成2 期
A Multicenter, Open-Label Study to Investigate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (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
- 3
- 试验地点
- 7
- 主要终点
- Overall response rate（ORR）
研究概览
简要总结
It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R DLBCL. There will be no control group in this study. Each subject will receive treatment orally every day in 28-day cycles. Each cycle starts immediately after the previously completed cycle without a break between cycles.
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 75 Years（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
ICP-022
Experimental
干预措施: ICP-022 (Drug)
结局指标
主要结局
Overall response rate（ORR）
时间窗: Up to 3 years
The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL
次要结局
- Occurrence of adverse events and serious adverse events(Up to 3 years)
- Progression free survival（PFS）(Up to 3 years)
- Duration of response（DOR）(Up to 3 years)
研究者
研究点 (7)
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