Quizartinib and High-dose Ara-C Plus Mitoxantrone in Relapsed/Refractory AML With FLT3-ITD

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.

Timeline

Start

2020-07-17

Primary completion

2022-09-11

Completion

2022-09-11

Publications

• Jaramillo S, Le Cornet L, Kratzmann M, Krisam J, Gorner M, Hanel M, Rollig C, Wass M, Scholl S, Ringhoffer M, Reichart A, Steffen B, Kayser S, Mikesch JH, Schaefer-Eckart K, Schubert J, Geer T, Martin S, Kieser M, Sauer T, Kriegsmann K, Hundemer M, Serve H, Bornhauser M, Muller-Tidow C, Schlenk RF. Q-HAM: a multicenter upfront randomized phase II trial of quizartinib and high-dose Ara-C plus mitoxantrone in relapsed/refractory AML with FLT3-ITD. Trials. 2023 Sep 15;24(1):591. doi: 10.1186/s13063-023-07421-x.

Drugs

Indications