Condition: AML, Adult · Sponsor: French Innovative Leukemia Organisation
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.
This description comes directly from the study's public registry record.
Ariane MINEUR · +33 (0)5 57 62 31 08 · ariane.mineur@chu-bordeaux.fr
Always discuss trial participation with your own doctor first.
| Amiens CHU | Amiens, France | Not Yet Recruiting |
| Angers CHU | Angers, France | Not Yet Recruiting |
| Avignon CH | Avignon, France | Not Yet Recruiting |
| Bayonne CH | Bayonne, France | Not Yet Recruiting |
| Besançon CHU | Besançon, France | Recruiting |
| Brest CHU | Brest, France | Not Yet Recruiting |
| Caen CHU | Caen, France | Not Yet Recruiting |
| CERGY PONTOISE - CH René Dubos | Cergy-Pontoise, France | Not Yet Recruiting |
| Hôpital d'Instruction des Armées PERCY | Clamart, France | Not Yet Recruiting |
| CHU Estaing | Clermont-Ferrand, France | Not Yet Recruiting |
| Corbeil-Essonnes - Ch Sud Francilien | Corbeil-Essonnes, France | Not Yet Recruiting |
| Créteil CHU HENRI MONDOR | Créteil, France | Not Yet Recruiting |
+ 30 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06263387