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Refractory AMLELEGANCENCT05193448

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

An observational study of Refractory AML and Relapsed Adult AML, run by French Innovative Leukemia Organisation at 38 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
177 participants
Where
38 sitesFrance
Study dates
5 Jul 2021to 31 Jan 2022
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.)

Who cannot join

  • 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

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

France38 sites

  • Amiens CHU

    Amiens

  • Angers CHU

    Angers

  • Avignon CH

    Avignon

  • Bayonne CH

    Bayonne

  • Besançon CHU

    Besançon

  • Brest CHU

    Brest

  • Caen CHU

    Caen

  • CERGY PONTOISE - CH René Dubos

    Cergy-Pontoise

  • CHU Estaing

    Clermont-Ferrand

  • Corbeil-Essonnes - Ch Sud Francilien

    Corbeil-Essonnes

  • Créteil CHU HENRI MONDOR

    Créteil

  • Dijon CHU

    Dijon

  • Grenoble CHU

    Grenoble

  • Le Mans CH

    Le Mans

  • Limoges CHU

    Limoges

  • Lyon sud CHU

    Lyon

  • Marseille IPC

    Marseille

  • Meaux CH de l'Est francilien

    Meaux

  • METZ-THIONVILLE CHR- Hôpital de Mercy

    Metz

  • Montpellier - Chu Saint Eloi

    Montpellier

  • Nantes CHU

    Nantes

  • Nice CHU

    Nice

  • Nimes CHU

    Nîmes

  • Paris La Pitié salpetrière

    Paris

  • Paris Necker

    Paris

  • Paris Saint Louis

    Paris

  • Bordeaux CHU

    Pessac

  • Reims CHU

    Reims

  • Rennes CHU

    Rennes

  • roubaix CH

    Roubaix

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez

  • Saint Quentin CH

    Saint-Quentin

  • Toulouse - IUCT Oncopole - Service d'Hématologie

    Toulouse

  • Tours CHU

    Tours

  • Troyes CH

    Troyes

  • Nancy CHU

    Vandœuvre-lès-Nancy

  • Versailles CH

    Versailles

  • Villejuif IGR

    Villejuif

Other trials in France

About this study

Official title: 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.

Medical subject headings
Leukemia, Myeloid, Acute

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2022
  2. Study start5 Jul 2021
  3. Primary completion31 Oct 2021
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
177 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05193448
Sponsor's protocol ID
ELEGANCE
Acronym
ELEGANCE
Status last verified
May 2023
First submitted
31 Dec 2021
Last updated
24 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Refractory AML and Relapsed Adult AML, run by French Innovative Leukemia Organisation at 38 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gilteritinib effectiveness in FLT3-mutated AML patients in R/R situation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05193448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.

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