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

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.

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Key information

Conditions

Refractory AML FLT3-ITD FLT3-TKD Mutation Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Relapsed Adult AML

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amiens CHU, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Gilteritinib effectiveness in FLT3-mutated AML patients in R/R situation

Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Collaborators

Acute Leukemia French Association

Registry information

Official study title

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

Acronym: ELEGANCE

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2022
First posted: Jan 14, 2022
Registry last updated: May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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