Venetoclax plus azacitidine versus standard intensive chemotherapy for patients with newly diagnosed acute myeloid leukemia (AML) and NPM1 mutations eligible for intensive treatment (VINCENT)

Acute myeloid leukemia

Modified Event-free survival (mEFS), Event is defined as: 1. Failure to achieve a CR/CRi/CRh after maximum of two induction cycles in the control arm (SOC) or three induction cycles in the investigational arm (VEN+AZA), i.e. primary induction failure, Event is defined as: 2. Hematologic relapse after previous CR/CRi/CRh, Event is defined as: 3. Molecular failure, defined as either: 3.1 Molecular progression, defined as confirmed ≥ 1 log10 increase of NPM1 MRD level in any two samples in a patient without prior MRD negativity or 3.2 Molecular relapse after previous MRD negativity, defined as confirmed ≥ 1 log10 between two consecutive positive samples in a patient who was previously tested as MRD negative, Event is defined as: 4. Death

Cumulative occurrence of grade 3 and 4 adverse events (tolerability), Rate of morphologic CR and CR/CRi/CRh with MRD negativity, MRD as detected by MFC and MRD kinetics in NPM1 real-time PCR, Rate of molecular response and molecular persistence, Relapse-free survival and overall survival, Early mortality (14 d, 30 d, 60 d from start of induction), Change in Health-related quality of life (QoL), Cumulative health-care resource use at 12 and 24 months

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