The Frequency of uMRD in Japanese Patients With CLL After 24 Months of Treatment With Venetoclax±Rituximab in the 2L+ in the Real-World Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)
研究概览
简要总结
Most cases of Chronic lymphocytic leukemia (CLL) remain an incurable disease with the goal of therapy being to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Japan.
Study participants will receive oral treatments of Venetoclax±Rituximab for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments Venetoclax±Rituximab will be enrolled. Around 89 participants will be enrolled in the study in sites in Japan.
Participants will receive oral venetoclax tablets ± intravenously (IV) infused rituximab treatments for CLL according to the approved local label. The overall study duration will be 27 months.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosed with relapsed/refractory (2 Line [2L]+) chronic lymphocytic leukemia (CLL) in Japan based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria at the time of informed consent (IC).
- •Treatment with Venetoclax±Rituximab for 24 months who are not treated with any other concurrent CLL treatment.
- •Expected to visit the hospital at + 3 months after treatment with Venetoclax±Rituximab for 24 months.
排除标准
- •No data on information on the start and end dates or continuation of treatment with Venetoclax.
- •Participating in other clinical trials.
结局指标
主要结局
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)
时间窗: Up to 27 Months
UMRD is defined as \<10\^-4 in peripheral blood (PB) assessed by flow cytometry (FCM).
次要结局
未报告次要终点