Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory

Acute Myeloid Leukemia Clinical Trial

— VENAURA  

Official title:

Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory Settings: a Multicentric Study From French AURAML Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06429670
• Other study ID #: 69HCL24_0521
• Status: Completed
• Start date: May 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: May 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Azacytidine and venetoclax combination regimen (AZA/VEN) is the standard of care in frontline acute myeloid leukemia (AML) settings for unfit to intensive chemotherapy patients. AZA/VEN combination regiment was approved in France in 2021 but was already used in outlabel fashion since 2019. However, AZA/VEN is also associated with an increased hematological toxicity compared to azacytidine alone. In this context, alternative AZA/VEN regimens emerged progressively based on each physician experience and local procedures. Moreover, AZA/VEN is also recognized as a valuable therapeutic option in relapse/refractory settings. In this multicentric study, the investigators aimed to evaluate the efficacy and safety of various AZA/VEN regimen in frontline and relapse/refractory (R/R) 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) and/or ≤ 10-4 for NPM1 by RT-qPCR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years old

• Acute myeloid leukemia patients at diagnostic, in relapse/refractory settings, or MRD relapse.

• receiving AZA/VEN combination regimen

Exclusion Criteria:

• Another VEN combination chemotherapy

• AZA/VEN initiation prior January 2019 and after December 2023

• Opposition to the study

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
France	Centre Hospitalier Pierre Oudot | Groupement hospitalier Nord	Bourgoin-Jallieu
France	METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,	Chambéry
France	CHU Clermont-Ferrand Site Estaing	Clermont-Ferrand
France	Centre Hospitalier Annecy Genevois	Épagny
France	CHU Grenoble Alpes	La Tronche
France	Centre Léon Bérard	Lyon
France	Hospices Civils de Lyon	Lyon
France	Centre Hospitalier de Roanne	Roanne
France	CHU de Saint-Étienne Hôpital Nord	Saint-Priest-en-Jarez
France	Centre Hospitalier de Valence	Valence
France	Ch de Valence	Valence
France	Hopital Vichy	Vichy

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival corresponds to time to death from the initiaiton of AZA/VEN, regardless of disease recurrence.	up to 5 months