A phase 3, multicenter, open-label, randomized, study of
Scheduled · 2021 until 2030
Midostaurin plus chemotherapy is the standard therapy in
AML for fit patients harboring a FLT3 mutation. However,
on the molecular level, midostaurin is an unselective multikinaseinhibitor
with rather weak inhibitory potential of mutated
FLT3. Midostaurin has no significant monoagent clinical
activity in AML.
Gilteritinib is a novel second generation TKI with high and
rather selective potency against mutant-FLT3. Further,
gilteritinib is capable to induce clinical meaningful remission
rates in AML.
This study now evaluates whether gilteritinib administered
with standard chemotherapy has superior response rates
(CR, OS) compared to the standard therapy including
If successful, this phase III study will change the current
standard of care in FLT3-mutated AML.