Gemtuzumab ozogamicin plus midostaurin in combination with standard ‘7 + 3’ induction therapy in newly diagnosed AML: Results from the SAL‐MODULE phase I study

Summary We conducted a phase I trial in newly diagnosed acute myeloid leukaemia (AML) to investigate the combination of two novel targeted agents, gemtuzumab ozogamicin (GO) and midostaurin, with intensive chemotherapy in FLT3 ‐mutated AML and CBF leukaemia. Three dose levels of midostaurin and one to three sequential doses of 3 mg/m 2 GO in combination with ‘7 + 3’ induction were evaluated. Based on safety findings in 12 patients, our results show that 3 mg/m 2 GO on Days 1 + 4 and 100 mg midostaurin on Days 8–21 can be safely combined with IC in newly diagnosed AML.