Trial Profile

A 2:1 Randomized Phase II Trial to Compare the Efficacy and Safety of Standard Chemotherapy Plus Quizartinib Versus Standard Chemotherapy Plus Placebo in Adult Patients With Newly Diagnosed FLT3 Wild-type AML

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 01 Oct 2025

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At a glance

02 Sep 2025 Status changed from active, no longer recruiting to completed.
10 Dec 2024 Primary endpoint has not been met (Event-free survival rate), according to Results presented at the 66th American Society of Hematology Annual Meeting and Exposition.
10 Dec 2024 Results (n=161) of enhanced validation of the FLT3-like gene expression signature as a predictive biomarker for quizartinib response in FLT3-ITD negative acute myeloid leukemia, presented at the 66th American Society of Hematology Annual Meeting and Exposition.

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