FLT3 and acute myeloid leukemia: However, the randomized phase 3 LACEWING trial, which compared the combination of gilteritinib plus azacitidine with azacitidine monotherapy in patients with ND FLT3-mutated AML or myelodysplastic syndrome (MDS) who were ineligible for intensive chemotherapy, did not meet the primary endpoint (overall survival) [25].