Informations générales (source: ClinicalTrials.gov)
Results From a Nationwide Cohort Temporary Utilization Authorization (ATU) of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC),Treated in France With Venetoclax Azacitidine (VENAZA)
Observational [Patient Registry]
French Innovative Leukemia Organisation (Voir sur ClinicalTrials)
juillet 2024
mars 2025
24 juillet 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Necker-Enfants Malades | Ambroise Marcais, Dr | Contact (sur clinicalTrials) | |||
| CENTRE HOSPITALIER SUD FRANCILIEN | Stephanie Haiat, Dr | Contact (sur clinicalTrials) | |||
| HOPITAL NOVO | ioana Vaida, Dr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Amiens CHU - Amiens - France | Delphine Lebon, Dr | Contact (sur clinicalTrials) | |||
| Angers CHU - Angers - France | Mathilde Hunault, Prof | Contact (sur clinicalTrials) | |||
| Avignon CH - Avignon - France | Safia Chebrek, dr | Contact (sur clinicalTrials) | |||
| Bayonne CH - Bayonne - France | Anne Banos, Dr | Contact (sur clinicalTrials) | |||
| Besançon CHU - Besançon - France | Yohann Desbrosses, Dr | Contact (sur clinicalTrials) | |||
| Bordeaux CHU - Pessac - France | Pierre-Yves Dumas, Prof | Contact (sur clinicalTrials) | |||
| Brest CHU - Brest - France | Gaelle Guillerm, Dr | Contact (sur clinicalTrials) | |||
| Caen CHU - Caen - France | sylvain Chantepie, Dr | Contact (sur clinicalTrials) | |||
| Centre de Lutte Contre le Cancer H. Becquerel - Rouen - France | Emilie Lemasle, Dr | Contact (sur clinicalTrials) | |||
| CHU Estaing - Clermont-Ferrand - France | Gaspar Aspas Requena, MD | Contact (sur clinicalTrials) | |||
| CHU Lille - Lille - France | Céline Berthon, Dr | Contact (sur clinicalTrials) | |||
| Créteil CHU HENRI MONDOR - Créteil - France | Cécile Pautas, Dr | Contact (sur clinicalTrials) | |||
| Dijon CHU - Dijon - France | Marie-Lorraine chretien, Dr | Contact (sur clinicalTrials) | |||
| Grenoble CHU - Grenoble - France | Martin Carré, Dr | Contact (sur clinicalTrials) | |||
| Hôpital d'Instruction des Armées PERCY - Clamart - France | Pierre Arnautou, Dr | Contact (sur clinicalTrials) | |||
| ICANS - Institut de cancérologie de strasbourg europe - Strasbourg - France | Célestine Simand, Dr | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie Lucien Neuwirth - Saint-Priest-en-Jarez - France | Emmanuelle tavernier, Dr | Contact (sur clinicalTrials) | |||
| Le Mans CH - Le Mans - France | Kamel Laribi, Dr | Contact (sur clinicalTrials) | |||
| Limoges CHU - Limoges - France | Pascal Turlure, Dr | Contact (sur clinicalTrials) | |||
| Lyon sud CHU - Lyon - France | Mael Heiblig, Pr | Contact (sur clinicalTrials) | |||
| Marseille IPC - Marseille - France | Sylvain GARCIAZ, Dr | Contact (sur clinicalTrials) | |||
| Meaux CH de l'Est francilien - Meaux - France | Jamilé Frayfer, Dr | Contact (sur clinicalTrials) | |||
| METZ-THIONVILLE CHR- Hôpital de Mercy - Metz - France | Houria Debarri, Dr | Contact (sur clinicalTrials) | |||
| Montpellier - Chu Saint Eloi - Montpellier - France | Ludovic Gabellier, Dr | Contact (sur clinicalTrials) | |||
| Nancy CHU - vandoeuvre les Nancy - France | Caroline Bonmati, Dr | Contact (sur clinicalTrials) | |||
| Nantes CHU - Nantes - France | Pierre Peterlin, Dr | Contact (sur clinicalTrials) | |||
| Nice CHU - Nice - France | Thomas Cluzeau, Prof | Contact (sur clinicalTrials) | |||
| Nimes CHU - Nîmes - France | Eric Jourdan, Dr | Contact (sur clinicalTrials) | |||
| Paris La Pitié salpetrière - Paris - France | Madalina Uzunov, Dr | Contact (sur clinicalTrials) | |||
| Paris Saint Louis - Paris - France | Emmanuel Raffoux, Prof | Contact (sur clinicalTrials) | |||
| Reims CHU - Reims - France | Chantal Himberlin, Dr | Contact (sur clinicalTrials) | |||
| Rennes CHU - Rennes - France | tony Marchand, Dr | Contact (sur clinicalTrials) | |||
| roubaix CH - Roubaix - France | Mathieu Wemeau, Dr | Contact (sur clinicalTrials) | |||
| Saint Quentin CH - Saint-Quentin - France | reda Garidi, Dr | Contact (sur clinicalTrials) | |||
| Toulouse - IUCT Oncopole - Service d'Hématologie - Toulouse - France | Toulouse - IUCT Oncopole - S d'Hématologie, Pr | Contact (sur clinicalTrials) | |||
| Tours CHU - Tours - France | Alban Villate, Dr | Contact (sur clinicalTrials) | |||
| Troyes CH - Troyes - France | Alberto santagostino, Dr | Contact (sur clinicalTrials) | |||
| Versailles CH - Versailles - France | Juliette Lambert, Dr | Contact (sur clinicalTrials) | |||
| Villejuif IGR - Villejuif - France | Florence Pasquier, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Adult patients
- treatment with VEN-AZA for newly diagnosed AML and ineligible to intensive
chemotherapy
- Treatment in the named-patients program (ATU)
- Adult patients
- treatment with VEN-AZA for newly diagnosed AML and ineligible to intensive
chemotherapy
- Treatment in the named-patients program (ATU)
- Treatment with VEN-AZA for previously treated AML
- Prior treatment for preexisting hematological malignancies other that AML,
including AZA is not an exclusion criteria
- HYDROXYCARBAMIDE given for AML is not an exclusion criteria
- AZA started before VEN for AML is not an exclusion criteria
- Opposition to data collection