NCT06476899尚未招募2 期
A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy in Previously Untreated CLL/SLL
Fei Li0 个研究点目标入组 60 人开始时间: 2024年7月24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
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- TTNTD rate at 30 months
研究概览
简要总结
Prospective, interventional, and practical clinical studies
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age between 18 and 70 years, with no gender restrictions;
- •Patients with CLL/SLL who meet the iwCLL2018 diagnostic criteria;
- •Indications for treatment
- •ECOG performance score of 0-2;
- •Patients are untreated or have not received standardized treatment
- •Before the trial screening, the subject or their legal representative voluntarily signs a written informed consent form, indicating that they understand the purpose of the study and the necessary research steps, and are able to comply with the protocol and follow-up.
排除标准
- •Has been diagnosed or treated for malignancies other than CLL (including active central nervous system lymphoma) within the past year;
- •there is clinical evidence of Richter transformation;
- •Participant cannot receive or plan to receive another treatment during study participation
- •Other conditions that the investigator considers inappropriate for participation
研究组 & 干预措施
Fixed regimen
Experimental
orelabrutinib + FCR/BR
干预措施: orelabrutinib (Drug)
Fixed regimen
Experimental
orelabrutinib + FCR/BR
干预措施: FCR/BR (Drug)
Control
Active Comparator
BTKi chosen by doctors
干预措施: BTK inhibitor (Drug)
结局指标
主要结局
TTNTD rate at 30 months
时间窗: 30 months
The proportion of time from the start of treatment to the start of the next treatment or death over a period of 30 months
次要结局
- PFS(3 years)
研究者
Fei Li
Chief physician
The First Affiliated Hospital of Nanchang University
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