A randomized phase III, global, multicentre, open label clinical trial comparing Venetoclax Azacitidine and Quizartinib vs Venetoclax and Azacitidine in newly diagnosed acute myeloid leukemia patient´s ineligible for standard induction chemotherapy.

Condition studied

Acute myeloid leukemia

Investigational medicinal product(s)

Eligibility

Primary endpoint

Overall survival (OS)

Endpoint detail

Event-free survival (EFS), Composite CR (CCR) (best response obtained on study), Early mortality (first 30 and 60 days), CR, CRh, and CRi with negative measurable residual disease (MRD) by NGS, CR, CRh, CRi and CCR at 1, 4 and 9 cycles of treatment, Time to CR, CRh, CRi, CCRCR, CRi, MLFS, PR, PD, Relapse-free survival (RFS), Cumulative incidence of relapse (CIR), Duration of response (DoR), Quality of life measurements (from the EuroQoL Group EQ-5D-5L and the EORTC QLQ-C30 instruments), Medical resources during treatement phase, Rates of RBC and platelet transfusion independence, duration of RBC transfusion independence and platelet transfusion independence and platelet and RBC transfusion independence, Minimal residual disease (MRD) by NGS, Separate analyses in secondary AML, CBF, FLT3-ITD, FLT3 other, NPM1, P53, IDH1/IDH2, and subsets