NCT03415035已完成不适用
Venetoclax in Chronic Lymphocytic Leukemia Effectiveness and Real-life Treatment Management
AbbVie120 个研究点 分布在 1 个国家目标入组 269 人开始时间: 2018年3月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 269
- 试验地点
- 120
- 主要终点
- Best Response of Venetoclax in Participants with Chronic Lymphocytic Leukemia (CLL) up to 12 Months
研究概览
简要总结
This study will evaluate real-life effectiveness and use in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with diagnosed Chronic Lymphocytic Leukemia (CLL) and eligible for venetoclax as per label.
- •Participants for whom the physician has decided to initiate CLL treatment with venetoclax.
- •Participants the physician believes he can personally follow over all the study period.
- •Participants who have been informed verbally and in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control.
排除标准
- •- Participating in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation.
结局指标
主要结局
Best Response of Venetoclax in Participants with Chronic Lymphocytic Leukemia (CLL) up to 12 Months
时间窗: Up to approximately 12 months
The best response is defined as the best response observed during the first year of study treatment among the possible responses to treatment: Complete Response (CR), CR with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR), Partial Response (PR), Stable Disease (SD), or Disease Progression (DP).
次要结局
- Time To Next Treatment(Up to approximately 48 months)
- Overall Response Rate (ORR)(Up to approximately 24 months)
- Change in Score of EuroQol 5 Dimensions (EQ-5D-5L)(Up to approximately 24 months)
- Time to First Response to Treatment (TTR)(Up to approximately 24 months)
- Overall survival (OS)(Up to approximately 48 months)
- Best Response under Next CLL Treatment(Up to approximately 48 months)
- Progression-Free Survival (PFS)(Up to approximately 48 months)
- Minimal Residual Disease(Up to approximately 24 months)
- Time to Best Response to Treatment(Up to approximately 24 months)
- Response Duration(Up to approximately 48 months)
- Time To Progression (TTP)(Up to approximately 48 months)
- PFS after Disease Progression Following Venetoclax Treatment(Up to approximately 48 months)
研究者
研究点 (120)
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