NCT07681258尚未招募不适用
ASC4Young: Real-World Study of Asciminib Safety and Efficacy in Young Adults With Chronic Myeloid Leukemia in the Gulf Region
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Major Molecular Response (MMR) Rate in Young Adults
研究概览
简要总结
The aim of this study is to evaluate the real-world effectiveness and safety of asciminib among young adults with chronic myeloid leukemia (CML) across the Gulf region. The data source for this study will consist of routinely collected clinical information documented within the electronic health records (EHR) of participating centers.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP)
- •Adult patients aged ≥ 18 years at the index date (or adult as defined by applicable national regulations)
- •Documented exposure to asciminib during the identification period (May 2023 to May 2026)
- •Provision of signed informed consent for secondary use of data, or an ethics committee-approved waiver of consent, where applicable (including for deceased patients or where data were previously collected within the EHR system)
排除标准
- •Patients who do not meet the eligibility criteria specified above
- •Patients with insufficient medical record documentation to determine asciminib exposure or key study outcomes
研究组 & 干预措施
Young Adults Cohort
CML patients aged ≤ 40 years at the first documented asciminib administration.
Older Adults Cohort
CML patients aged > 40 years at the first documented asciminib administration.
结局指标
主要结局
Major Molecular Response (MMR) Rate in Young Adults
时间窗: Approximately 12 Months
MMR is defined as a BCR::ABL1 level on the International Scale (BCR::ABL1 IS) ≤ 0.1%.
次要结局
- Incidence of Adverse Events (AEs)(Approximately 3, 6, and 12 months)
- Number of Patients by Type and Severity of AEs(Approximately 3, 6, and 12 months)
- Number of Patients by Reasons for Treatment Interruptions and Subsequent Treatment Switching(Approximately 3, 6, and 12 months)
- Number of Patients by Reason for Treatment Switch(Approximately 3, 6, and 12 months)
- Incidence of AEs Leading to Dose Modifications(Approximately 3, 6, and 12 months)
- Number of Treatment Interruptions Due to AEs(Approximately 3, 6, and 12 months)
- Duration of Treatment Interruptions Due to AEs(Approximately 3, 6, and 12 months)
- Time to Treatment Discontinuation due to Adverse Events (TTDAE)(Approximately 3, 6, and 12 months)
- Proportion of Patients who Achieve an Early Molecular Response Milestone of BCR::ABL1 IS ≤ 10% After 3 Months of Treatment(3 months)
- Proportion of Patients who Achieve an Early Molecular Response Milestone of BCR::ABL1 IS ≤ 1% After 6 Months of Treatment(6 months)
- MMR in Patients Aged > 40 years(Approximately 12 months)
- Rate of Deep Molecular Response(Approximately 12 months)
- Number of Patients With Prior Tyrosine Kinase Inhibitor (TKI) Treatment(Up to 12 months prior to Baseline)
- Duration of CML at Time of Asciminib Treatment Initiation(Baseline)
- Asciminib Starting Dose(Baseline)
- Number of Patients With Dose Modifications(Approximately 3, 6, and 12 months)
- Number of Treatment Interruptions(Approximately 3, 6, and 12 months)
- Duration of Treatment Interruptions(Approximately 3, 6, and 12 months)
- Number of Patients by Clinicopathological Characteristics(Up to 12 months pre-Baseline, Baseline, and approximately 3, 6 , and 12 months post-Baseline)
研究者
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