Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 88
- 主要终点
- Percentage of Participants with a Grade 3 or Higher Treatment-emergent Adverse Events (AEs)
研究概览
简要总结
This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN/LOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued follow-up visits. Treatment will be given every 4 weeks and this study is expected to last about 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Are actively participating in study J2N-MC-JZNN/LOXO-BTK-20020
排除标准
- •This is not applicable to this study
研究组 & 干预措施
Pirtobrutinib (Arm A)
Participants receive pirtobrutinib orally
干预措施: Pirtobrutinib (Drug)
Idelalisib (Arm B)
Participants receive idelalisib orally
干预措施: Idelalisib (Drug)
结局指标
主要结局
Percentage of Participants with a Grade 3 or Higher Treatment-emergent Adverse Events (AEs)
时间窗: Time from First Dose of Study Intervention (Study Day 1) through 30 Days After Last Dose of Study Intervention or Start of New Anticancer Therapy, whichever is Earlier
次要结局
- Overall Survival(Time from Enrollment in the Originator Study until Death from Any Cause (Up to 93 Months))