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

Completed

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT06429670
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-09-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• >18 years old
• Acute myeloid leukemia patients at diagnostic, in relapse/refractory settings, or MRD relapse.
• receiving AZA/VEN combination regimen

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Exclusion Criteria

• Another VEN combination chemotherapy
• AZA/VEN initiation prior January 2019 and after December 2023
• Opposition to the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	up to 5 months	Overall survival corresponds to time to death from the initiaiton of AZA/VEN, regardless of disease recurrence.

Trial Locations

Locations (12)

Centre Léon Bérard; 🇫🇷 Lyon, France

METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,; 🇫🇷 Chambéry, France

CHU Grenoble Alpes; 🇫🇷 La Tronche, France

CHU Clermont-Ferrand Site Estaing; 🇫🇷 Clermont-Ferrand, France

Centre Hospitalier de Roanne; 🇫🇷 Roanne, France

Ch de Valence; 🇫🇷 Valence, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Centre Hospitalier Pierre Oudot | Groupement hospitalier Nord; 🇫🇷 Bourgoin-Jallieu, France

CHU de Saint-Étienne Hôpital Nord; 🇫🇷 Saint-Priest-en-Jarez, France

Centre Hospitalier de Valence; 🇫🇷 Valence, France

Hopital Vichy; 🇫🇷 Vichy, France

Centre Hospitalier Annecy Genevois; 🇫🇷 Épagny, France