This is a phase II, single-arm, open-label, multi-center study in adult patients with Acute
Myeloid Leukemia (AML) and FLT3-ITD as defined in inclusion/exclusion criteria.
The primary efficacy object is to evaluate the impact of midostaurin given in combination
with intensive induction, consolidation including allogeneic hematopoietic stem cell
transplantation and single agent maintenance therapy on event-free survival (EFS) in adult
patients with AML exhibiting a FLT3-ITD.
Sample size: 440 patients
The treatment duration of an individual patient is between 18 and 24 months. Duration of the
study for an individual patient including treatment (induction, consolidation [chemotherapy
or allogeneic SCT], maintenance and follow-up period: Maximum 8 years