Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine

Primary outcomes

• characterize the overall response rate, in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort [18 months (since Cycle 1 Day 1)]: 1. Rate of complete remission and complete remission with incomplete hematologic recovery (CR/CRi), 2. Rate of morphological leukemia free state (MLFS) 3. Rate of CR/CRi rate with negative minimal residual disease (MRD) assessed by flow cytometry (FCT) and/or molecular techniques if available
• characterize the overal survival (OS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort [18 months (since Cycle 1 Day 1)]: rate of OS according to the 2022 European LeukemiaNet (ELN)
• characterize the event free survival (EFS) in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life cohort [18 months (since Cycle 1 Day 1)]: rate of EFS according to the 2022 European LeukemiaNet (ELN)

Secondary outcomes

• characterize the incidence and relatedness of serious adverse events (SAE), in patients treated by Venetoclax/Azacitidine (VEN/AZA), in real life [18 months (since Cycle 1 Day 1)]: description of grade 3/4 SAE and death according to CTCAE v5.
• describe the management of Venetoclax/Azacitidine (VEN/AZA) in a real -life cohort of patient. [18 months (since Cycle 1 Day 1)]: daily dose and duration of Venetoclax and Azacitidine description of Venetoclax and Azacitidine dose modification description of Venetoclax and Azacitidine duration

Sex: All, ages: 18 Years to any

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

• Sylvain GARCIAZ, MD-PhD, Principal investigator, French Innovative Leukemia Organisation