NCT07458542进行中（未招募）不适用
Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年12月9日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Relapse-free survival (RFS)
研究概览
简要总结
The purpose of this study is to assess real-world effectiveness and safety of oral azacitidine in adults diagnosed with acute myeloid leukemia (AML) in Hong Kong
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
- •Documented diagnosis of Acute Myeloid Leukemia (AML).
- •Achieved first complete response (CR) or complete response with incomplete blood recovery (CRi) following intensive induction chemotherapy.
- •Not able or unwilling to undergo Hematopoietic Stem Cell Transplantation (HSCT).
- •Received oral azacitidine as maintenance therapy after first CR or CRi following intensive induction chemotherapy in real-world settings (Note: CR/CRi status at oral azacitidine treatment initiation is left to the judgment of the local clinicians depending on the treatment response and the condition of the patient in routine clinical practices).
- •Age ≥ 18 years at the index date (oral azacitidine initiation date).
排除标准
- •Evidence of relapse prior to oral azacitidine initiation recorded in electronic health record (EHR).
研究组 & 干预措施
Group 1
Participants with acute myeloid leukemia (AML) receiving oral azacitidine
干预措施: Azacitidine (Drug)
结局指标
主要结局
Relapse-free survival (RFS)
时间窗: Up to 40 months
次要结局
- Overall survival (OS)(Up to 40 months)
- Incidence rates of adverse events (AEs)(Up to 40 months)
- Incidence rates of adverse events serious adverse events (SAEs)(Up to 40 months)
- Complete blood count (CBC) results(Up to 40 months)
- Bone marrow biopsy/aspiration test results(Up to 40 months)
- Number of participants with abnormal extended serum chemistry panel results(Up to 40 months)
- Oral azacitidine treatment duration(Up to 40 months)
- Total number of days dosed with oral azacitidine(Up to 40 months)
- Number of treatment cycles(Up to 40 months)
- Total cumulative oral azacitidine dose(Up to 40 months)
- Average daily dose of oral azacitidine(Up to 40 months)
- Oral azacitidine dose intensity(Up to 40 months)
- Oral azacitidine dose adjustments(Up to 40 months)
研究者
研究点 (1)
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