A Post-marketing Observational Study for Venetoclax in Patients Diagnosed With Acute Myeloid Leukemia in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 424
- 试验地点
- 281
- 主要终点
- Percentage of Participants With ≥ Grade 3 Neutropenia of Venetoclax Regimens With Unfit Acute Myeloid Leukemia (AML)
研究概览
简要总结
Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. This study will assess how safe and effective oral venetoclax is in participants with AML. Adverse events and change in disease activity will be monitored under routine clinical practice.
Venetoclax is an approved drug to treat Acute Myeloid Leukemia (AML). Around 400 participants of any age who are treated with oral venetoclax tablets for AML in accordance with the approved label will be enrolled in the study across Japan.
Participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets.
There is expected to be no additional burden for participants in this study. Data will be collected by information provided by participating physicians based on routine medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants who are administered venetoclax for treatment of AML.
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants With ≥ Grade 3 Neutropenia of Venetoclax Regimens With Unfit Acute Myeloid Leukemia (AML)
时间窗: Up to 52 weeks.
Percentage of participants with a high grade (≥ Grade 3) protocol specified neutropenia during and after treatment with venetoclax.
次要结局
- Percentage of Participants With Tumor Lysis Syndrome (TLS)(Up to 52 weeks)
- Percentage of Participants With AE/ADR When Used Concomitantly With CYP3A Inhibitors or Growth Colony Stimulating Factor (G-CSF)(Up to 52 weeks)
- Percentage of Participants With Composite Complete Remission Rate (CR + CRi)(Up to 52 weeks)
- Percentage of Participants With Febrile Neutropenia and Thrombocytopenia(Up to 52 weeks)
- Percentage of Participants Reported Adverse Events (AE)/Adverse Drug Reaction (ADR)(Up to 52 weeks)
- Median Time to Best Response(Up to 52 weeks.)
- Median Treatment Duration(Up to 52 weeks)
- Median Duration of Composite Complete Remission(Up to 52 weeks)
- Percentage of Participants Reported >= Grade 3 Adverse Events (AE)/Adverse Drug Reactions (ADR)(Up to 52 weeks)
- Median Overall Survival(Up to 52 weeks)