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Clinical Trial Summary

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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05193448
Study type Observational [Patient Registry]
Source French Innovative Leukemia Organisation
Status Active, not recruiting
Start date July 30, 2021
Completion date January 31, 2022

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