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 (ELEGANCE)

French Innovative Leukemia Organisation

Status: Completed

Conditions: FLT3-ITD; Relapsed Adult AML; FLT3-TKD Mutation; Refractory AML

Study type: Observational

Funder types: Other

Identifiers

NCT05193448

ELEGANCE

Details and patient eligibility

About

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.

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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