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)

May 23, 2023 updated by: French Innovative Leukemia Organisation

A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed FLT3 Mutated Acute MyEloid Leukemia 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Amiens Chu
      • Angers, France
        • Angers Chu
      • Avignon, France
        • Avignon CH
      • Bayonne, France
        • Bayonne CH
      • Besançon, France
        • Besançon CHU
      • Brest, France
        • Brest CHU
      • Caen, France
        • Caen CHU
      • Cergy-Pontoise, France
        • CERGY PONTOISE - CH René Dubos
      • Clermont-Ferrand, France
        • CHU Estaing
      • Corbeil-Essonnes, France
        • Corbeil-Essonnes - Ch Sud Francilien
      • Créteil, France
        • Créteil CHU HENRI MONDOR
      • Dijon, France
        • Dijon Chu
      • Grenoble, France
        • Grenoble Chu
      • Le Mans, France
        • Le Mans CH
      • Limoges, France
        • Limoges Chu
      • Lyon, France
        • Lyon sud CHU
      • Marseille, France
        • Marseille IPC
      • Meaux, France
        • Meaux CH de l'Est francilien
      • Metz, France
        • METZ-THIONVILLE CHR- Hôpital de Mercy
      • Montpellier, France
        • Montpellier - Chu Saint Eloi
      • Nantes, France
        • Nantes CHU
      • Nice, France
        • Nice CHU
      • Nîmes, France
        • Nimes CHU
      • Paris, France
        • Paris Necker
      • Paris, France
        • Paris Saint Louis
      • Paris, France
        • Paris La Pitié salpetrière
      • Pessac, France
        • Bordeaux CHU
      • Reims, France
        • Reims Chu
      • Rennes, France
        • Rennes Chu
      • Roubaix, France
        • roubaix CH
      • Saint-Priest-en-Jarez, France
        • Institut de Cancérologie Lucien Neuwirth
      • Saint-Quentin, France
        • Saint Quentin CH
      • Toulouse, France
        • Toulouse - IUCT Oncopole - Service d'Hématologie
      • Tours, France
        • Tours CHU
      • Troyes, France
        • Troyes Ch
      • Versailles, France
        • Versailles CH
      • Villejuif, France
        • Villejuif Igr
      • vandoeuvre les Nancy, France
        • Nancy Chu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

≥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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Innovative Leukemia Organisation

Collaborators

Acute Leukemia French Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2021

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

December 31, 2021

First Submitted That Met QC Criteria

December 31, 2021

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELEGANCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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