The composite complete remission rate was 67% (n=10/15); four and six patients achieved complete
remission and complete remission with incomplete hematologic recovery, respectively; two patients
(13%) achieved a partial response, giving an overall response rate of 80%.
One DLT from 11 DLT-evaluable patients informed the decision to proceed to randomization at 120-
mg/day gilteritinib for combination treatment.
Conclusions: In ND FLT3mut+ AML patients unfit for standard chemotherapy, gilteritinib plus AZA was
well tolerated, and induced antileukemic responses. Based on these findings, patients are being
enrolled into the randomized portion of the study; patients in the combination arm will receive 120-
mg gilteritinib.
