Quizartinib and High-dose Ara-C Plus Mitoxantrone in Relapsed/Refractory AML With FLT3-ITD
Status:
Recruiting
Trial end date:
2026-07-01
Target enrollment:
Participant gender:
Summary
In this multicenter, upfront randomized phase II trial, all patients receive quizartinib in
combination with HAM (high-dose cytarabine, mitoxantrone) during salvage therapy. Efficacy is
assessed by comparison to historical controls based on the matched threshold crossing
approach. During consolidation therapy (chemotherapy as well as allo-HCT) patients receive
either prophylactic quizartinib therapy or MRD-triggered preemptive continuation therapy with
quizartinib according to up-front randomization.