NCT03987958进行中（未招募）不适用
Prospective Non-interventional Study to Describe the Effectiveness and Safety of Venetoclax in Acute Myeloid Leukemia (AML) Patients in Routine Clinical Practice (REVIVE Study)
AbbVie12 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Overall Survival
研究概览
简要总结
This study will describe the safety and effectiveness of venetoclax in AML patients in routine clinical practice in Israel. The decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.
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
- •Participant diagnosed with Acute Myeloid Leukemia (AML) and is eligible to receive venetoclax per Israel Ministry of Health.
- •Participant who will be treated with venetoclax and the decision to treat with venetoclax is made by the physician prior to any decision regarding participation in this study.
排除标准
- •- Participant participating in an interventional trial within 30 days prior to starting venetoclax treatment.
研究组 & 干预措施
Venetoclax
Participants in this observational study will receive treatment with venetoclax for AML.
The decision to treat with venetoclax has been made independently from this observational study before participants are offered the opportunity to participate in this study.
结局指标
主要结局
Overall Survival
时间窗: Time from treatment to death from any cause, up to approximately 30 months
Overall survival is defined as the time from the date of first treatment to the date of death from any cause.
次要结局
- Change in patient reported outcomes for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire CORE (EORTC QLQ-C30)(Week 0 to approximately 30 months)
- Percentage of participants achieving composite complete remission (CR or CRi)(Approximately 30 months)
- Change in patient reported outcomes for the Euro Quality of Life 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L)(Week 0 to approximately 30 months)
- Percentage of participants treated with venetoclax as compared to participants treated with other approved biologics(Up to approximately 30 months)
- Time to transfusion independence(Up to 30 months)
- Percentage of participants achieving transfusion independence(Up to 30 months)
研究者
研究点 (12)
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