Long-Term Safety of Pirtobrutinib in Participants From Study J2N-MC-JZNJ With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 13
- 试验地点
- 11
- 主要终点
- Percentage of Participants with Grade 3 or Higher Treatment-emergent Adverse Events
研究概览
简要总结
The purpose of this study is to find out more about the long-term safety of pirtobrutinib in participants with previously treated types of blood cancer. Participants must have chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkins lymphoma. The study is open to those who completed the original study - J2N-MC-JZNJ (NCT04849416) and continue to benefit from treatment. Treatment will be given every 12 weeks and this study is expected to last about 5 years.
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
- •Currently enrolled and active in the originator study, JZNJ. A participant is considered active in the study if they are receiving study intervention
- •Agree to comply with contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
排除标准
- •Are pregnant, or intend to become pregnant during the study, or within 30 days of last dose of study treatment or to breastfeed during the study or within 1 week of the last dose of study treatment
研究组 & 干预措施
Pirtobrutinib
Pirtobrutinib administered orally.
干预措施: Pirtobrutinib (Drug)
结局指标
主要结局
Percentage of Participants with Grade 3 or Higher Treatment-emergent Adverse Events
时间窗: Day 1 through 28 days after last dose or start of new anticancer therapy
Percentage of Participants with Grade 3 or Higher Treatment-emergent Adverse Events
时间窗: Day 1 through 28 days after last dose or start of new anticancer therapy
次要结局
未报告次要终点