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

Relapsed Adult AML Clinical Trial

— ELEGANCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05193448
• Other study ID #: ELEGANCE
• Status: Completed
• Start date: July 5, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2023
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: January 31, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• FLT3-TKD Mutation
• Leukemia, Myeloid, Acute
• Refractory AML
• Relapsed Adult AML

Locations

Country	Name	City	State
France	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	Créteil CHU HENRI MONDOR	Créteil
France	Dijon CHU	Dijon
France	Grenoble CHU	Grenoble
France	Le Mans CH	Le Mans
France	Limoges CHU	Limoges
France	Lyon sud CHU	Lyon
France	Marseille IPC	Marseille
France	Meaux CH de l'Est francilien	Meaux
France	METZ-THIONVILLE CHR- Hôpital de Mercy	Metz
France	Montpellier - Chu Saint Eloi	Montpellier
France	Nantes CHU	Nantes
France	Nice CHU	Nice
France	Nimes CHU	Nîmes
France	Paris La Pitié salpetrière	Paris
France	Paris Necker	Paris
France	Paris Saint Louis	Paris
France	Bordeaux CHU	Pessac
France	Reims CHU	Reims
France	Rennes CHU	Rennes
France	roubaix CH	Roubaix
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez
France	Saint Quentin CH	Saint-Quentin
France	Toulouse - IUCT Oncopole - Service d'Hématologie	Toulouse
France	Tours CHU	Tours
France	Troyes CH	Troyes
France	Nancy CHU	vandoeuvre les Nancy
France	Versailles CH	Versailles
France	Villejuif IGR	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
French Innovative Leukemia Organisation	Acute Leukemia French Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months