NCT03989713: Q-HAM

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

Terminated Phase 2 Last updated 15 September 2022

What this trial tests

Phase 2 trial testing MRD-triggered arm in AML According to WHO 2016 Classification (Except Acute Promyelocytic Leukemia) AND (Refractory to Induction Therapy OR Relapsed After First Line Treatment) in 11 participants. Terminated before completion.

Timeline

17 July 2020

Primary endpoint
11 September 2022

11 September 2022

Quick facts

Lead sponsor	Prof. Dr. Richard F Schlenk
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	17 July 2020
Primary completion	11 September 2022
Estimated completion	11 September 2022
Sites	1 location across Germany

Drugs / interventions tested

• MRD-triggered arm — full drug profile →
• Prophylactic Arm

Conditions studied

• AML According to WHO 2016 Classification (Except Acute Promyelocytic Leukemia) AND (Refractory to Induction Therapy OR Relapsed After First Line Treatment) — all drugs for AML According to WHO 2016 Classification (Except Acute Promyelocytic Leukemia) AND (Refractory to Induction Therapy OR Relapsed After First Line Treatment) →

Sponsor

Prof. Dr. Richard F Schlenk

Who can join

Adults 18 to 75, any sex, with AML According to WHO 2016 Classification (Except Acute Promyelocytic Leukemia) AND (Refractory to Induction Therapy OR Relapsed After First Line Treatment). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A review of FLT3 inhibitors in acute myeloid leukemia.
   Zhao JC, Agarwal S, Ahmad H, Amin K, et al · · 2022 · cited 137× · PMID 34774343 · DOI 10.1016/j.blre.2021.100905
2. <i>FLT3</i> Mutations in Acute Myeloid Leukemia: Key Concepts and Emerging Controversies.
   Kennedy VE, Smith CC. · · 2020 · cited 132× · PMID 33425766 · DOI 10.3389/fonc.2020.612880
3. Advances in targeted therapy for acute myeloid leukemia.
   Yu J, Jiang PYZ, Sun H, Zhang X, et al · · 2020 · cited 48× · PMID 32477567 · DOI 10.1186/s40364-020-00196-2
4. MRD Tailored Therapy in AML: What We Have Learned So Far.
   Ngai LL, Kelder A, Janssen JJWM, Ossenkoppele GJ, et al · · 2020 · cited 37× · PMID 33575214 · DOI 10.3389/fonc.2020.603636
5. Profile of Quizartinib for the Treatment of Adult Patients with Relapsed/Refractory FLT3-ITD-Positive Acute Myeloid Leukemia: Evidence to Date.
   Fletcher L, Joshi SK, Traer E. · · 2020 · cited 26× · PMID 32021432 · DOI 10.2147/cmar.s196568
6. Treatment of Acute Myeloid Leukemia in the Era of Genomics-Achievements and Persisting Challenges.
   Green SD, Konig H. · · 2020 · cited 21× · PMID 32536937 · DOI 10.3389/fgene.2020.00480
7. Developments and challenges of FLT3 inhibitors in acute myeloid leukemia.
   Ge SS, Liu SB, Xue SL. · · 2022 · cited 18× · PMID 36185253 · DOI 10.3389/fonc.2022.996438
8. Advances and Challenges in Quizartinib-Based FLT3 Inhibition for Acute Myeloid Leukemia: Mechanisms of Resistance and Prospective Combination Therapies.
   Bruzzese A, Martino EA, Labanca C, Mendicino F, et al · · 2025 · cited 4× · PMID 39763167 · DOI 10.1111/ejh.14383