A Post Approval Surveillance of Scemblix® (Asciminib) in Patients With Chronic Myeloid Leukemia (CML) in Korea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 18
- 主要终点
- Percentage of participants with a SUAE/ SUADR
研究概览
简要总结
This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Asciminib in the real-world clinical setting in Korean Chronic myeloid leukemia (CML) patients.
详细描述
The dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of Asciminib.
This study will enroll all patients by total enumeration for those prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice for 2 years after the market launch.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients diagnosed with Ph+ CP-CML and currently receiving or going to receive Scemblix® treatment according to locally approval label
- •Patients who are willing to provide written informed consent prior to study enrollment
排除标准
- •Patients with contraindication according to locally approved label of Scemblix®
- •Patients who receive or are going to receive any investigational medicine during the observation period
研究组 & 干预措施
Asciminib
Patients prescribed with Asciminib at physicians' discretion as per locally approved label under usual clinical practice
干预措施: Asciminib (Other)
结局指标
主要结局
Percentage of participants with a SUAE/ SUADR
时间窗: 24 weeks
Percentage of participants with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)
Percentage of participants with a SAE / SADR
时间窗: 24 weeks
Percentage of participants with a serious AE (SAE)/ serious ADR (SADR)
Percentage of participants with an UAE/ UADR
时间窗: 24 weeks
Percentage of participants with an unexpected AE (UAE)/ unexpected ADR (UADR)
Percentage of participants with an AE / ADR
时间窗: 24 weeks
Percentage of participants with an adverse event (AE)/ adverse drug reaction (ADR)
次要结局
- Major molecular response rate(week 12, week 24)
- Molecular response 4.5 rate(week 12 ,week 24)
- Molecular response 4 rate(week 12, week 24)
- Number of participants with CCyR and/or BCR-ABL1 IS<1%(week 12,week 24)