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临床试验/NCT06211153
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)

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年12月31日最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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