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
1 other identifier
observational
177
1 country
38
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
Shorter than P25 for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedFirst Submitted
Initial submission to the registry
December 31, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedMay 24, 2023
May 1, 2023
4 months
December 31, 2021
May 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
≥18 years of age FLT3-mutated R/R AML as defined by the WHO Classification between the periods of March 1st, 2019 to September 30, 2021 allowing 6-months follow-up for the last patient included (March, 19 2019 to September 18, 2019 for French "ATU nominative"; September 18, 2019 to January 08, 2020 for French "ATU de cohorte"; January 08, 2020 to March 30, 2021 for "post ATU" period) treated in virtually all AML center in France
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
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
Vandœuvre-lès-Nancy, France
Versailles CH
Versailles, France
Villejuif IGR
Villejuif, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 31, 2021
First Posted
January 14, 2022
Study Start
July 5, 2021
Primary Completion
October 31, 2021
Study Completion
January 31, 2022
Last Updated
May 24, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share