NCT04980859尚未招募3 期
A Phase III, Single-arm Clinical Trial of Zebutinib Combined With Immunochemotherapy With Limited Course of Treatment for Newly Treated Chronic Lymphocytic Leukemia Patients Without 17p-
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- MRD conversion rate (minimal residual disease conversion rate)
研究概览
简要总结
To investigate limited course of treatment of Zebutinib combined with immunochemotherapy for patients with newly treated chronic lymphocytic leukemia without 17p-/TP53 mutation
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
- •CLL patients with indications for treatment according to iwCLL;
- •CT/MRI shows measurable lesions;
- •ECOG score is 0-2;
- •No pregnancy plans during treatment
排除标准
- •Richter transformation;
- •17p-/TP53 amplification ≥20% (FISH);
- •Received steroids within 7 days before starting treatment;
- •Have previously received treatments for chronic lymphocytic leukemia;
- •Vaccine live attenuated vaccine within 4 weeks of randomization;
- •Any life-threatening disease;
- •Central nervous system leukemia;
- •Apoplexy, history of intracranial hemorrhage;
- •HIV or HCV or HBVpositive
研究组 & 干预措施
Zebutinib Combined With CIT arm
Experimental
Zebutinib Combined With FCR( under 60 years of age) or BR (over 60 years of age )
干预措施: Zebutinib&BR or Zebutinib&FCR (Drug)
结局指标
主要结局
MRD conversion rate (minimal residual disease conversion rate)
时间窗: 30 days
minimal residual disease conversion rate
次要结局
- PFS (progression-free survival)(3 years)
- OS (overall survival)(3 years)
研究者
Ru Feng
Professor
Nanfang Hospital, Southern Medical University
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