NCT07375355招募中不适用
Explore the Effectiveness and Safety of Scemblix (Asciminib) for Newly Diagnosed CML-CP Patients in China Real World Setting (ASC4CN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Cumulative rate of MMR
研究概览
简要总结
This is a multicenter, non-interventional real-world study designed to assess the efficacy and safety of asciminib in patients with newly diagnosed CML.The study uses a prospective data collection design to gather baseline, pre- and post-treatment, and long-term follow-up data, enabling a comprehensive assessment of asciminib's clinical benefits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients eligible for inclusion in this study must meet all the following criteria:
- •18 years or older at the time of ICF signing;
- •Newly diagnosed with Ph+ CML-CP within 3 months before enrollment;
- •- The diagnosis documentation must include the type and quantitative level of the BCR-ABL1 transcript.
- •Prior treatment with a maximum of 2 weeks of TKIs;
- •Prior treatment with non-TKI regimens, including interferon and hydroxyurea, is allowed;
- •Patients scheduled to initiate treatment with asciminib;
- •- Patients beginning asciminib treatment must receive the first dose within 14 days of signing the ICF;
- •Signed ICF.
排除标准
- •Patients meeting any of the following criteria are not eligible for inclusion in this study:
- •Previous diagnosis of CML-accelerated phase or blast crisis;
- •Currently participating in an interventional clinical study for CML;
- •Having rare, atypical transcript types that cannot be standardised internationally;
- •Women who are pregnant, lactating or planning to become pregnant during the study;
- •Concurrent other malignancies (refer to the International ICD-11 diagnosis codes, with diagnostic text including carcinoma, malignant neoplasm, etc.);
- •Other conditions that are considered not suitable for the study by the investigator.
研究组 & 干预措施
Study Group
Asciminib treatment
结局指标
主要结局
Cumulative rate of MMR
时间窗: Month 12
Cumulative rate of major molecular response (MMR) (BCR-ABL1 transcript level ≤ 0.1%) in patients receiving asciminib for 12 months
次要结局
- Cumulative rate of MMR(Month 3, Month 6, Month 9, Month 18 and Month 24)
- Cumulative rate of deep molecular response (DMR): MR4 and MR4.5(Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24)
- Cumulative rate of complete cytogenetic response (CCyR)(Month 3, Month 6, and Month 12)
- Time to first MMR(24 month follow up period)
- Time to first MR4 and MR4.5(24 month follow up period)
- Time to first complete cytogenetic response (CCyR)(24 month follow up period)
- Early molecular response (EMR) rate at 3 months(Month 3)
- Complete hematologic response (CHR) rate(Month 1, Month 2, and Month 3)
- Rate of decline in BCR::ABL1 transcript levels(Baseline, Month 1, Month 2, Month 3, Month 6, Month 9 and Month 12)
- Duration of MMR(24 month follow up period)
- Duration of MR4 and MR4.5(24 month follow-up period)
- Event-Free survival (EFS) rate(Month 12 and Month 24)
- Progression-free survival (PFS) rate(Month 12 and Month 24)
- Overall survival (OS) rate(Month 12 and Month 24)
- Adverse events (AEs) and serious adverse events (SAEs) occurring during asciminib treatment(24 month follow-up period)
- Asciminib persistence rates(Month 6, Month 12, and Month 24)
- Rates of asciminib treatment interruption/dose reduction and discontinuation due to AEs(24 month follow-up period)
- Proportion of patients requiring concomitant medications due to AEs(24 month follow-up period)
- Change in the simplified CML quality of life questionnaire from baseline(Baseline, Month 12 and Month 24)
- Compliance following asciminib treatment(24 month follow-up period)
- Concomitant medication use associated with AEs related to asciminib(24 month follow-up period)
- Hospitalization rate, outpatient visit rate, emergency department visit rate, and ICU admission rate related to CML treatment(24 month follow-up period)
- Gene mutation rate associated with asciminib treatment(24 month follow-up period)
研究者
研究点 (1)
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