NCT04695431已完成不适用
An External Control, Observational, Retrospective Study Assessing the Effect of Avapritinib Compared With Best Available Therapy for Patients With Advanced Systemic Mastocytosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 6
- 主要终点
- Comparative evaluation of overall survival (OS) between patients receiving best available therapy versus avapritinib in BU-285-2101 and BLU-285-2202
研究概览
简要总结
BLU-285-2405 is a multi-center, synthetic control, observational and retrospective study designed to compare clinical outcomes for avapritinib compared with best available therapy for patients with AdvSM.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparative evaluation of overall survival (OS) between patients receiving best available therapy versus avapritinib in BU-285-2101 and BLU-285-2202
时间窗: up to 12 years
Overall Survival defined as time from initiation of systemic treatment to death from any cause
次要结局
- Comparative evaluation between patients receiving best available therapy versus avapritinib of duration of treatment (DOT)(Up to 12 years)
- Comparative evaluation between patients receiving best available therapy versus avapritinib and time to next treatment line (TtNTL)(Up to 12 years)
- Comparative evaluation of change in serum tryptase concentration in patients receiving best available therapy versus avapritinib(Up to 12 years)
- To characterize the safety profile and conduct comparative evaluation of safety between patients receiving best available therapy vs. avapritinib(Up to 12 years)
研究者
研究点 (6)
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