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
NCT ID: NCT05193448
Last Updated: 2023-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
177 participants
OBSERVATIONAL
2021-07-05
2022-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Acute Leukemia French Association
OTHER
French Innovative Leukemia Organisation
OTHER
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ELEGANCE
Identifier Type: -
Identifier Source: org_study_id
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