A phase I-II, multicentre, open label clinical trial to assess the safety and tolerability of the combination of low-dose cytarabine or azacitidine, plus Venetoclax and Quizartinib in newly diagnosed acute myeloid leukemia patients aged equal or more than 60 years old ineligible for standard induction chemotherapy

Newly diagnosed acute myeloid leukemia patients aged equal or more than 60 years old

Phase I: Recommended phase 2 dose (RP2D) of AZA based and LDAC based triple combination with Quizartinib and Venetoclax schedules -Phase II: CR/CRi rate of AZA based and LDAC based triple combination with Quizartinib and Venetoclax schedules

CR/CRi rate after 1, and 4 cycles, Overall survival (OS), Safety and tolerability of the AZA based and LDAC based triple combination with Quizartinib and Venetoclax schedules (overall hematologic and non-hematologic toxicity), Event-free survival (EFS), Disease-free survival (DFS), Relapse-free survival (RFS), Quality of life (from the EuroQoL Group EQ-5D-5L and the EORTC QLQ-C30 instruments), Medical resources during treatment phase, Minimal residual disease (MRD), CRh rate (Bone marrow blasts <5% with partial hematologic recovery defined as ANC ≥0.5 × 109/L and platelet count ≥50 × 109/L, with no evidence of extramedullary leukemia and cannot be classified as CR), Early mortality (first 30 and 60 days), Separate analyses in secondary AML, CBF, FLT3-ITD, NPM1, P53, and IDH1/IDH2 subsets., Exploration of biomarkers predictive of drug activity and duration of response. Potential analyses may include: o To evaluate the MRD negativity rate in the BM using MPFC and NGS o Immune recovery o Exhaustive biomarker plan including baseline and relapse molecular characterization by NGS

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