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The therapeutic prognosis of newly diagnosed patients with FMS-like tyrosine kinase 3 (FLT3)-mutated (FLT3 mut+ ) acute myeloid leukemia (AML) remains unsatisfactor.
The study is a multicenter, open-label, phase 3 randomized trial that enrolled previously untreated patients with FLT3 mut+ AML who were not candidates for intensive induction chemotherapy, randomized 2:1 to gilteritinib (120 mg) / day, oral) + azacitidine group (GIL + AZA) or azacitidine alone group (AZA.
As of the interim analysis on August 26, 2020, a total of 123 patients had been randomized into two groups: 74 in the GIL+AZA group and 49 in the AZA grou.
Median event-free survival (EFS) was 03 months in both group.
The incidence of adverse events (AEs) was similar between the two groups, with the incidence of grade 3 or higher AEs being 99% and 84%, respectivel.
In conclusion, although the overall survival of the two groups was similar, gillettinib combined with azacitidine treatment could significantly improve the complete remission rate of FLT3mut+ AML patient.
Original source:
Wang Eunice S, Montesinos Pau, Minden Mark D et a.
