Scemblix® (Asciminib): Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML-CP in Real World Setting in France
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 201
- 试验地点
- 52
- 主要终点
- Proportion of patients remaining on asciminib at 12 months
研究概览
简要总结
The purpose of this study is to enhance the knowledge on asciminib treatment in a broader and real-life population by collecting additional data to characterize the treatment patterns of patients treated with asciminib, with a primary objective represented by maintenance on treatment at 12 months.
详细描述
The ASSURE-3 study is a national, multicentric, non-interventional, prospective study in real-life conditions with primary data collection in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more Tyrosine Kinase Inhibitors (TKIs). It will be conducted in France with hematologists, onco-hematologists, physicians with documented involvement in managing Ph+ CML-CP patients in routine practice, practicing in public or private health care institutions. Each patient will be followed during 15 months at M0, M1 and then every 3 months (rhythm of visits according to the routine clinical care), or until premature discontinuation of asciminib treatment.
Historical data will be abstracted retrospectively by the participating physicians from patient files, to collect information using an electronic case report form (eCRF). Primary data will be collected during inclusion and follow-up visits
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
- •Patient aged ≥ 18 years at inclusion,
- •Patient with Ph+ CML-CP previously treated with two or more TKIs,
- •Patient for whom a decision has been taken by the treating physician (investigator) to initiate treatment with asciminib according to his own practice, the drug label / Summary of Product Characteristics (SmPC), and regardless of study participation,
- •Patient having given their non objection to participate to the study
排除标准
- •Patient with CML in accelerated phase (AP) or blastic phase (BP) at enrolment,
- •Patient with known history of T315I mutation,
- •Patient who previously received asciminib treatment,
- •Patient currently participating to an interventional clinical trial,
- •Patient with known contra-indication to asciminib according to the SmPC.
研究组 & 干预措施
Asciminib
Adult patients with Ph+ CML-CP previously treated with two or more tyrosine kinase inhibitors
干预措施: Asciminib (Other)
结局指标
主要结局
Proportion of patients remaining on asciminib at 12 months
时间窗: Month 12
Proportion of patients remaining on asciminib treatment at 12 months to be provided
次要结局
- Time from the first MMR to the first loss of MMR - for patients not in MMR at treatment initiation(Up to 15 months)
- Event-Free Surviva (EFS)(Up to 15 months)
- Comorbidity profile(Baseline)
- Disease characteristics(Baseline)
- History of TKI treatment(Baseline)
- Proportion of patients in major molecular response (MMR) - for patients not in MMR at treatment initiation(12 months)
- BCR::ABL1 on the International Scale (IS) kinetics along treatment - for all patients(15 months)
- Progression-Free Survival (PFS)(Up to 15 months)
- Exposure patterns to asciminib(15 months)
- Proportion of patient with an AE described during asciminib treatment among patient reporting the same AE which led to discontinuation with previous TKI treatments(Up to 15 months)
- Proportion of patients in MMR - for patients in MMR at treatment initiation(12 months)
- Management of patients in real-life(15 months)
- EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30)(Baseline, 3months, 6months, 9months, 12months, 15months)
- Emergence of mutations(Up to 15 months)
- Proportion of patients in MR2, MMR, MR4.0, MR4.5, uMR4.5 - for all patients(3 months, 6 months, 9 months, 12 months and 15 months)
- Time to MMR from the index date - for patients not in MMR at treatment initiation(Up to 15 months)
- EORTC QLQ-CML24 questionnaire(Baseline, 3months, 6months, 9months, 12months, 15months)