Multicenter phase 3 trial of addition of cladribine to idarubicin-cytarabine induction for de novo acute myeloid leukemia

A multicenter phase 3 trial in China evaluated addition of cladribine (C) to the idarubicine-cytarabine (IA) induction regimen for newly diagnosed acute myeloid leukemia (AML).The overall complete remission rate (CR) was 80.5% in the IAC group versus 72.4% in the IA group (p=0.029) and the 2-year overall survival (OS) rate was 81.3% in the IAC group versus 70.0% in the IA group (p=0.011). Among patients with adverse risk disease, the CR rate was 69.8% in the IAC group versus 49% in the IA group (p=0.008) and the 2-year OS rate was 80.1% in the IAC group versus 58.1% in the IA group (p=0.014). There were no differences in chemotherapy-related toxicities between the groups. The authors conclude that addition of cladribine to idarubicin-cytarabine induction for newly diagnosed AML was safe and effective.