A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed (R/R) FLT3 Mutated Acute MyEloid Leukemia (AML) Patients Treated With Gilteritinib in FrANCE

Study Overview
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Brief Summary
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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.

Official Title
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A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed FLT3 Mutated Acute MyEloid Leukemia Patients Treated With Gilteritinib in FrANCE

Conditions
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Refractory AML, Relapsed Adult AML, FLT3-TKD Mutation, FLT3-ITD

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gilteritinib effectiveness in FLT3-mutated AML patients in R/R situation | 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 | 6 months |