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.
Study Type
OBSERVATIONAL
Enrollment
177
Amiens CHU
Amiens, France
Angers CHU
Angers, France
Avignon CH
Avignon, France
Bayonne CH
Bayonne, France
Besançon CHU
Besançon, France
Brest CHU
Brest, France
Caen CHU
Caen, France
CERGY PONTOISE - CH René Dubos
Cergy-Pontoise, France
CHU Estaing
Clermont-Ferrand, France
Corbeil-Essonnes - Ch Sud Francilien
Corbeil-Essonnes, France
...and 28 more locations
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
Time frame: 6 months
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