Status:
COMPLETED
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
Lead Sponsor:
French Innovative Leukemia Organisation
Collaborating Sponsors:
Acute Leukemia French Association
Conditions:
Refractory AML
Relapsed Adult AML
Eligibility:
All Genders
18+ years
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT05193448
Start Date
July 5 2021
End Date
January 31 2022
Last Update
May 24 2023
Active Locations (38)
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1
Amiens CHU
Amiens, France
2
Angers CHU
Angers, France
3
Avignon CH
Avignon, France
4
Bayonne CH
Bayonne, France