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Spots Global Cancer Trial Database for Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory

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Trial Identification

Brief Title: 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 ID: NCT06429670

Interventions

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

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, , France

Centre Hospitalier Annecy Genevois, Épagny, , France

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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