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

Completed

• Conditions: FLT3-TKD Mutation; FLT3-ITD; Refractory AML; Relapsed Adult AML

• Registration Number: NCT05193448
• Lead Sponsor: French Innovative Leukemia Organisation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-05
• Primary Completion: 2021-10-31
• Study First Submitted: 2021-12-31
• Study First Submitted QC: 2021-12-31
• Study First Posted: 2022-01-14
• Study Completion: 2022-01-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gilteritinib effectiveness in FLT3-mutated AML patients in R/R situation	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

Trial Locations

Locations (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

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