A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed FLT3 Mutated Acute MyEloid Leukemia Patients Treated With Gilteritinib in FrANCE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 38
- 主要终点
- Gilteritinib effectiveness in FLT3-mutated AML patients in R/R situation
研究概览
简要总结
Gilteritinib is available in early access in France through Temporary Authorisation of Use (or ATU program) since March 2019. The ATU program reflects a real-life treatment situation and the related clinical data would help to better understand the benefit/risk profile of gilteritinib and to better document gilteritinib efficacy and safety in patients who received midostaurine in First Line (1L) setting.
The main objective is to describe gilteritinib effectiveness in FLT3 (Fms Related Tyrosine Kinase 3) -mutated AML patients in Refractory/Relapsed(R/R) situation treated in the context of early access program to gilteritinib in France through Temporary Authorisation of Use, the so-called ATU program, and the post ATU period from marketing authorisation to launch when reimbursement and price are published.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ≥ 18 years at AML diagnosis
- •Patients that started gilteritinib during ATU and post-ATU period from 19th March 2019 to 30th March2021
- •Patients diagnosed with refractory or relapsed AML as defined by the World Health Organization (WHO) Classification
- •Patients with FLT3 genetic testing performed at diagnosis and/or at R/R (if available)
- •Gilteritinib with or without other drug (chemotherapy, hypomethylating agent, hydroxyurea, etc.)
排除标准
- •Newly diagnosed AML patients
- •Participant opposed to the collection and analysis of their medical data
- •Prescription of gilteritinib out of the scope of its marketing authorisation approval such as post HSCT maintenance in patients in first complete remission after intensive chemotherapy
- •persons placed in curatorship,guardianship or guardianship orders
结局指标
主要结局
Gilteritinib effectiveness in FLT3-mutated AML patients in R/R situation
时间窗: 6 months
best response obtained according to European Leukemia Net (ELN) 2017 recommendations and ADMIRAL definitions effectiveness will also described in the following subgroups : refractory after 1st line chemo, 1rst relapse =\< 6 months after Complete Remission (CR) 1, 1st relapse \> 6 months after CR1, refractory after 1 st relapse salvage treatment, beyond the first relapse (\>= 2nd relapse), post Hematopoietic Stem Cell Transplantation (HSCT), post 1L midostaurine and by ELN 2017 risk groups
次要结局
未报告次要终点