Gemtuzumab ozogamicin plus midostaurin in combination with standard ‘7 + 3’ induction therapy in newly diagnosed <scp>AML</scp>: Results from the <scp>SAL‐MODULE phase I</scp> study
Christoph Röllig, Christoph Schliemann, Leo Ruhnke, Lars Fransecky, Björn‐Niklas Heydrich, Maher Hanoun, Richard Noppeney, Kerstin Schäfer‐Eckart, Knut Wendelin, Jan‐Henrik Mikesch, Jan Moritz Middeke, Manja Reimann, Frank Fiebig, Sven Zukunft, Martin Wermke, Hubert Serve, Uwe Platzbecker, Carsten Müller‐Tidow, Claudia D. Baldus, Martin Bornhäuser
Abstract
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.