Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429670
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2024-05-13
Brief Title:
Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and RelapseRefractory
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and RelapseRefractory Settings a Multicentric Study From French AURAML Group
Status:
COMPLETED
Status Verified Date:
2024-05
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:
VENAURA
Brief Summary:
Azacytidine and venetoclax combination regimen AZAVEN is the standard of care in frontline acute myeloid leukemia AML settings for unfit to intensive chemotherapy patients AZAVEN combination regiment was approved in France in 2021 but was already used in outlabel fashion since 2019 However AZAVEN is also associated with an increased hematological toxicity compared to azacytidine alone In this context alternative AZAVEN regimens emerged progressively based on each physician experience and local procedures Moreover AZAVEN is also recognized as a valuable therapeutic option in relapserefractory settings In this multicentric study the investigators aimed to evaluate the efficacy and safety of various AZAVEN regimen in frontline and relapserefractory RR patients diagnosed with AML in real life setting
The investigators will retrospectively analyze clinical outcome of patients from 11 different French centers Saint-Etienne Clermont-Ferrand Lyon Hopital Lyon Sud Centre Léon Bérard Vichy Annecy Chambery Valence Bourgoin-Jallieu Grenoble Roanne in Auvergne Rhône Alpes AURA region between January 2019 and December 2023 Composite complete remission was defined as in VIALE-A trial Measurable residual disease MRD negativity was defined as 10-3 by flow cytometry on bone marrow andor 10-4 for NPM1 by RT-qPCR
The investigators will retrospectively analyze clinical outcome of patients from 11 different French centers Saint-Etienne Clermont-Ferrand Lyon Hopital Lyon Sud Centre Léon Bérard Vichy Annecy Chambery Valence Bourgoin-Jallieu Grenoble Roanne in Auvergne Rhône Alpes AURA region between January 2019 and December 2023 Composite complete remission was defined as in VIALE-A trial Measurable residual disease MRD negativity was defined as 10-3 by flow cytometry on bone marrow andor 10-4 for NPM1 by RT-qPCR
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