NCT06211153已完成不适用
Real-world Effectiveness of Asciminib and Treatment Patterns in Patients With Chronic Myeloid Leukemia With T315I Mutation - a Chart Review Study of Patients Treated in the Asciminib Managed Access Program (MAP)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Major molecular response (MMR) by 6 months
研究概览
简要总结
This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.
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
Major molecular response (MMR) by 6 months
时间窗: By 6 months
Major molecular response (MMR) at 6 months
时间窗: At 6 months
次要结局
- MMR at and by 3, 9, and 12 months(At and by 3, 9, and 12 months)
- Time to first CCyR at and by 3, 6, 9, and 12 months(At and by 3, 6, 9, and 12 months)
- Time from CML diagnosis to study index (i.e., asciminib) start date(Baseline)
- Prior TKIs between CML diagnosis and T315I mutation diagnosis(Baseline)
- Gender(Baseline)
- Complete cytogenic response (CCyR) at and by 3, 6, 9, and 12 months(At and by 3, 6, 9, and 12 months)
- Country of residence(Baseline)
- Complete hematologic response (CHR) at and by 3, 6, 9, and 12 months(At and by 3, 6, 9, and 12 months)
- Number of patients per response type at asciminib start date(Baseline)
- Overall tyrosine kinase inhibitors (TKIs) prior to index date(Baseline)
- Number of patients with intolerance to last TKI prior to asciminib, per category(Baseline)
- Asciminib discontinuation(Up to 13 months)
- Status of CML at baseline(Baseline)
- Stem-cell transplant performed status(Baseline)
- Race(Baseline)
- Medical history by system-organ-class, preferred term from CML diagnosis to asciminib start date(Baseline)
- Number of patients with response to prior TKIs from CML diagnosis to asciminib (index date)(Baseline)
- Asciminib dose(Up to 13 months)
- Duration of exposure to asciminib(Up to 13 months)
- Prior TKIs between T315I mutation diagnosis and index date(Baseline)
- Number of patients with response to prior TKIs between CML diagnosis to T315I mutation diagnosis(Baseline)
- Number of patients with response to prior TKIs between T315I mutation diagnosis to asciminib start (index date)(Baseline)
- Sequence of prior TKI treatment patterns(Baseline)
- Number of patients with intolerance to prior TKIs, per category(Baseline)
研究者
研究点 (1)
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