Ignite Creation Date:
2024-05-06 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05193448
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2021-12-31
Brief Title:
A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed RR FLT3 Mutated Acute MyEloid Leukemia AML Patients Treated With Gilteritinib in FrANCE
Sponsor:
French Innovative Leukemia Organisation
Organization:
French Innovative Leukemia Organisation
Study Overview
Official Title:
A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed FLT3 Mutated Acute MyEloid Leukemia Patients Treated With Gilteritinib in FrANCE
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELEGANCE
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 benefitrisk 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 RefractoryRelapsedRR 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
The main objective is to describe gilteritinib effectiveness in FLT3 Fms Related Tyrosine Kinase 3 -mutated AML patients in RefractoryRelapsedRR 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None