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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05193448
Other study ID # ELEGANCE
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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