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


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 1L setting. The main objective is to describe gilteritinib effectiveness in FLT3-mutated AML patients in 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.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: October 31, 2021

Clinical Trial Outcome Measures

Primary Measures

  • Gilteritinib effectiveness in FLT3-mutated AML patients in R/R situation
    • Time Frame: 6 months
    • best response obtained according to ELN2017 recommendations and ADMIRAL definitions effectiveness will also described in the following subgroups : refractory after 1st line chemo, 1rst relapse =< 6 months after CR1, 1st relapse > 6 months after CR1, refractory after 1 st relapse salvage treatment, beyond the first relapse (>= 2nd relapse), post HSCT, post 1L midostaurine and by ELN 2017 risk groups

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients ≥ 18 years at AML diagnosis – Patients that started gilteritinib during ATU and post-ATU period from 19th March2019 to 30th March2021 – Patients diagnosed with refractory or relapsed AML as defined by the 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • French Innovative Leukemia Organisation
  • Collaborator
    • Acute Leukemia French Association
  • Provider of Information About this Clinical Study
    • Sponsor

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