Clinical trial NCT06429670: Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia
azacitdine
venetoclax
MRD
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every adult patients ( \>18 years old) with a diagnostic of AML treated by the association of AZACYTIDINE and VENETOCLAX between January 2019 and December 2023.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bourgoin-Jallieu
country: France
facility: Centre Hospitalier Pierre Oudot | Groupement hospitalier Nord
city: Chambéry
country: France
facility: METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand Site Estaing
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Roanne
country: France
facility: Centre Hospitalier de Roanne
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Étienne Hôpital Nord
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Valence
country: France
facility: Ch de Valence
city: Vichy
country: France
facility: Hopital Vichy
city: Épagny
country: France
facility: Centre Hospitalier Annecy Genevois
Study officials:
References: