AML, Adult Clinical Trial
— VENAZAOfficial title:
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
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.
Status | Not yet recruiting |
Enrollment | 230 |
Est. completion date | March 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients - treatment with VEN-AZA for newly diagnosed AML and ineligible to intensive chemotherapy - Treatment in the named-patients program (ATU) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Amiens CHU | Amiens | |
France | Angers CHU | Angers | |
France | Avignon CH | Avignon | |
France | Bayonne CH | Bayonne | |
France | Besançon CHU | Besançon | |
France | Brest CHU | Brest | |
France | Caen CHU | Caen | |
France | CERGY PONTOISE - CH René Dubos | Cergy-Pontoise | |
France | Hôpital d'Instruction des Armées PERCY | Clamart | |
France | CHU Estaing | Clermont-Ferrand | |
France | Corbeil-Essonnes - Ch Sud Francilien | Corbeil-Essonnes | |
France | Créteil CHU HENRI MONDOR | Créteil | |
France | Dijon CHU | Dijon | |
France | Grenoble CHU | Grenoble | |
France | Le Mans CH | Le Mans | |
France | CHU Lille | Lille | |
France | Limoges CHU | Limoges | |
France | Lyon sud CHU | Lyon | |
France | Marseille IPC | Marseille | |
France | Meaux CH de l'Est francilien | Meaux | |
France | METZ-THIONVILLE CHR- Hôpital de Mercy | Metz | |
France | Montpellier - Chu Saint Eloi | Montpellier | |
France | Nantes CHU | Nantes | |
France | Nice CHU | Nice | |
France | Nimes CHU | Nîmes | |
France | Paris La Pitié salpetrière | Paris | |
France | Paris Necker | Paris | |
France | Paris Saint Louis | Paris | |
France | Bordeaux CHU | Pessac | |
France | Reims CHU | Reims | |
France | Rennes CHU | Rennes | |
France | roubaix CH | Roubaix | |
France | Centre de Lutte Contre le Cancer H. Becquerel | Rouen | |
France | Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez | |
France | Saint Quentin CH | Saint-Quentin | |
France | ICANS - Institut de cancérologie de strasbourg europe | Strasbourg | |
France | Toulouse - IUCT Oncopole - Service d'Hématologie | Toulouse | |
France | Tours CHU | Tours | |
France | Troyes CH | Troyes | |
France | Nancy CHU | vandoeuvre les Nancy | |
France | Versailles CH | Versailles | |
France | Villejuif IGR | Villejuif |
Lead Sponsor | Collaborator |
---|---|
French Innovative Leukemia Organisation | Acute Leukemia French Association |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | characterize the overall response rate, in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort | Rate of complete remission and complete remission with incomplete hematologic recovery (CR/CRi),
Rate of morphological leukemia free state (MLFS) Rate of CR/CRi rate with negative minimal residual disease (MRD) assessed by flow cytometry (FCT) and/or molecular techniques if available |
18 months (since Cycle 1 Day 1) | |
Primary | characterize the overal survival (OS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort | rate of OS according to the 2022 European LeukemiaNet (ELN) | 18 months (since Cycle 1 Day 1) | |
Primary | characterize the event free survival (EFS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort | rate of EFS according to the 2022 European LeukemiaNet (ELN) | 18 months (since Cycle 1 Day 1) | |
Secondary | characterize the incidence and relatedness of serious adverse events (SAE), in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life | description of grade 3/4 SAE and death according to CTCAE v5. | 18 months (since Cycle 1 Day 1) | |
Secondary | describe the management of Venetoclax/Azacitidine (VEN/AZA) in a real -life cohort of patient. | daily dose and duration of Venetoclax and Azacitidine description of Venetoclax and Azacitidine dose modification description of Venetoclax and Azacitidine duration | 18 months (since Cycle 1 Day 1) |
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