Maintenance therapy with the FMS-like tyrosine kinase 3 inhibitor gilteritinib in patients with FMS-like tyrosine kinase 3-internal tandem duplication acute myeloid leukemia: A phase 2 study.

Compared with placebo, gilteritinib treatment showed a numerical trend of improvement in RFS (8.2 months) but this was not statistically significant (HR, 0.74; 95% CI, 0.41–1.34; p = .16), and the primary objective was not met.

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Conclusions The primary end point was not achieved; however, an observed trend toward potential benefit was noted in patients with FLT3 ‐ITD AML who had not undergone prior HSCT.

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In summary, although the primary end point of improved RFS with gilteritinib compared with placebo did not reach statistical significance at the 2‐year mark, some benefits and no new safety signals were observed with gilteritinib treatment.

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