protocolSection identificationModule nctId: NCT06263387, orgStudyIdInfo id: FILObsLAM_VENAZA, briefTitle: Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine, acronym: VENAZA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: French Innovative Leukemia Organisation, class: OTHER, collaborators name: Acute Leukemia French Association, descriptionModule briefSummary: Following the results of the phase 1b and the phase 3 studies, Venetoclax/Azacitidine (VEN/AZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program.Venetoclax (VEN) has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. Between February 15, 2021, and June 30, 2021, 285 requests for ATU were made to the pharmaceutical company (Abbvie) and led to the initiation of treatment of more than 230 patients. At the end of ATU period, all these 230 ATU patients continued to be treated by VEN/AZA as part of the current post-ATU period. Healthcare professionals and health care decision makers need real world data to better understand the benefit/risk profile of treatment. Early access to treatment in France is close to real-life setting condition., conditionsModule conditions: AML, Adult, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 230, type: ESTIMATED, outcomesModule primaryOutcomes measure: characterize the overall response rate, in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort, primaryOutcomes measure: characterize the overal survival (OS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort, primaryOutcomes measure: characterize the event free survival (EFS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort, secondaryOutcomes measure: characterize the incidence and relatedness of serious adverse events (SAE), in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life, secondaryOutcomes measure: describe the management of Venetoclax/Azacitidine (VEN/AZA) in a real -life cohort of patient., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amiens CHU, city: Amiens, country: France, geoPoint lat: 49.9, lon: 2.3, locations facility: Angers CHU, city: Angers, country: France, geoPoint lat: 47.46667, lon: -0.55, locations facility: Avignon CH, city: Avignon, country: France, geoPoint lat: 43.94834, lon: 4.80892, locations facility: Bayonne CH, city: Bayonne, country: France, geoPoint lat: 43.48333, lon: -1.48333, locations facility: Besançon CHU, city: Besançon, country: France, geoPoint lat: 47.24878, lon: 6.01815, locations facility: Brest CHU, city: Brest, country: France, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Caen CHU, city: Caen, country: France, geoPoint lat: 49.18585, lon: -0.35912, locations facility: CERGY PONTOISE - CH René Dubos, city: Cergy-Pontoise, country: France, geoPoint lat: 49.03894, lon: 2.07805, locations facility: Hôpital d'Instruction des Armées PERCY, city: Clamart, country: France, geoPoint lat: 48.80299, lon: 2.26692, locations facility: CHU Estaing, city: Clermont-Ferrand, country: France, geoPoint lat: 45.77966, lon: 3.08628, locations facility: Corbeil-Essonnes - Ch Sud Francilien, city: Corbeil-Essonnes, country: France, geoPoint lat: 48.60603, lon: 2.48757, locations facility: Créteil CHU HENRI MONDOR, city: Créteil, country: France, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Dijon CHU, city: Dijon, country: France, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Grenoble CHU, city: Grenoble, country: France, geoPoint lat: 45.16667, lon: 5.71667, locations facility: Le Mans CH, city: Le Mans, country: France, geoPoint lat: 48.0, lon: 0.2, locations facility: CHU Lille, city: Lille, country: France, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Limoges CHU, city: Limoges, country: France, geoPoint lat: 45.83153, lon: 1.25781, locations facility: Lyon sud CHU, city: Lyon, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Marseille IPC, city: Marseille, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Meaux CH de l'Est francilien, city: Meaux, country: France, geoPoint lat: 48.96014, lon: 2.87885, locations facility: METZ-THIONVILLE CHR- Hôpital de Mercy, city: Metz, country: France, geoPoint lat: 49.11911, lon: 6.17269, locations facility: Montpellier - Chu Saint Eloi, city: Montpellier, country: France, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Nantes CHU, city: Nantes, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Nice CHU, city: Nice, country: France, geoPoint lat: 43.70313, lon: 7.26608, locations facility: Nimes CHU, city: Nîmes, country: France, geoPoint lat: 43.83333, lon: 4.35, locations facility: Paris La Pitié salpetrière, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Paris Necker, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Paris Saint Louis, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Bordeaux CHU, city: Pessac, country: France, geoPoint lat: 44.81011, lon: -0.64129, locations facility: Reims CHU, city: Reims, country: France, geoPoint lat: 49.25, lon: 4.03333, locations facility: Rennes CHU, city: Rennes, country: France, geoPoint lat: 48.11198, lon: -1.67429, locations facility: roubaix CH, city: Roubaix, country: France, geoPoint lat: 50.69421, lon: 3.17456, locations facility: Centre de Lutte Contre le Cancer H. Becquerel, city: Rouen, country: France, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Institut de Cancérologie Lucien Neuwirth, city: Saint-Priest-en-Jarez, country: France, geoPoint lat: 45.47501, lon: 4.37614, locations facility: Saint Quentin CH, city: Saint-Quentin, country: France, geoPoint lat: 49.84889, lon: 3.28757, locations facility: ICANS - Institut de cancérologie de strasbourg europe, city: Strasbourg, country: France, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Toulouse - IUCT Oncopole - Service d'Hématologie, city: Toulouse, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Tours CHU, city: Tours, country: France, geoPoint lat: 47.38333, lon: 0.68333, locations facility: Troyes CH, city: Troyes, country: France, geoPoint lat: 48.3, lon: 4.08333, locations facility: Nancy CHU, city: vandoeuvre les Nancy, country: France, geoPoint lat: 48.65, lon: 6.18333, locations facility: Versailles CH, city: Versailles, country: France, geoPoint lat: 48.8, lon: 2.13333, locations facility: Villejuif IGR, city: Villejuif, country: France, geoPoint lat: 48.7939, lon: 2.35992, hasResults: False