NCT05933967招募中2 期
A Phase II, Prospective ,Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
Shandong Cancer Hospital and Institute2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- complete response rate
研究概览
简要总结
This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.
详细描述
The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma
- •Age 18-70 years
- •ECOG performance status 0-2
- •Ann Arbor stage II-IV
- •8.Subjects who in line with the testing standard of the clinical trial laboratory
- •Life expectancy ≥ 3months
排除标准
- •• systemic lymphoma involved CNS.
- •Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases.
- •uncontrolled infections (including HBV, HCV, HIV/AIDS)
- •Subjects who prepared for transplantation
- •Pregnancy or active lactation
研究组 & 干预措施
orelabrutinib+R-CHOP
Experimental
干预措施: Orelabrutinib+R-CHOP (Drug)
结局指标
主要结局
complete response rate
时间窗: up to 24 weeks
次要结局
- ORR(up to 24 weeks)
- The occurrence of adverse events and serious adverse events(up to 30 months)
- 2 years progression-free survival(From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years])
- 2 years overall survival(From date of receiving the first dose until the date of death from any cause,assessed up to 2 years)
研究者
Zengjun Li
Head of the Hematology Department
Shandong Cancer Hospital and Institute
研究点 (2)
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