NCT03135054 is a Phase 2 clinical trial of Quizartinib in AML, sponsored by The University of Hong Kong.

Who is sponsoring NCT03135054?

NCT03135054 is sponsored by The University of Hong Kong.

What drugs are being tested in NCT03135054?

Interventions in NCT03135054: Quizartinib, Omacetaxine Mepesuccinate Injection.

What condition does NCT03135054 study?

NCT03135054 studies AML, FLT3-ITD Mutation.

Is NCT03135054 still recruiting?

NCT03135054 is currently status unknown. Last updated 10 December 2020.

Last reviewed 2020-12-10 · How we verify

NCT03135054

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Combination of Quizartinib and Omacetaxine Mepesuccinate for AML Carrying FLT3-ITD

Status unknown Phase 2 Last updated 10 December 2020

What this trial tests

Phase 2 trial testing Quizartinib in AML in 40 participants. Status unknown.

Timeline

1 October 2017

Primary endpoint
1 October 2020

1 October 2021

Quick facts

Lead sponsor	The University of Hong Kong
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 October 2017
Primary completion	1 October 2020
Estimated completion	1 October 2021
Sites	1 location across Hong Kong

Drugs / interventions tested

Quizartinib (QUIZARTINIB) — full drug profile →
Omacetaxine Mepesuccinate Injection — full drug profile →

Conditions studied

AML — all drugs for AML →
FLT3-ITD Mutation — all drugs for FLT3-ITD Mutation →

Sponsor

The University of Hong Kong

Who can join

18 and older, any sex, with AML or FLT3-ITD Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study aims to test if combination of quizartinib (AC220) and omacetaxine mepesuccinate (OM, also known as homoharringtonine) results in durable composite complete remission (CRc) in patients with newly diagnosed or relapsed/refractory (R/R) acute myeloid leukemia (AML) carrying FLT3-ITD (Fms-Like Tyrosine Kinase 3 - Internal Tandem Duplication).

Publications & conference data

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

Plant Secondary Metabolites as Anticancer Agents: Successes in Clinical Trials and Therapeutic Application.
Seca AML, Pinto DCGA. · · 2018 · cited 331× · PMID 29337925 · DOI 10.3390/ijms19010263
Recent advances in targeted therapies in acute myeloid leukemia.
Bhansali RS, Pratz KW, Lai C. · · 2023 · cited 151× · PMID 36966300 · DOI 10.1186/s13045-023-01424-6
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
<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
Emerging treatment paradigms with FLT3 inhibitors in acute myeloid leukemia.
Short NJ, Kantarjian H, Ravandi F, Daver N. · · 2019 · cited 86× · PMID 30800259 · DOI 10.1177/2040620719827310
Mechanisms Underlying Resistance to FLT3 Inhibitors in Acute Myeloid Leukemia.
Eguchi M, Minami Y, Kuzume A, Chi S. · · 2020 · cited 54× · PMID 32722298 · DOI 10.3390/biomedicines8080245
Molecular Mechanisms of Resistance to FLT3 Inhibitors in Acute Myeloid Leukemia: Ongoing Challenges and Future Treatments.
Scholl S, Fleischmann M, Schnetzke U, Heidel FH. · · 2020 · cited 50× · PMID 33212779 · DOI 10.3390/cells9112493
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

Verify or expand the search:

Other trials of Quizartinib

Trials testing the same drug.

NCT06769490 — Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia · Phase 1 · recruiting
NCT06578247 — Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML · Phase 3 · recruiting
NCT06740825 — Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects · Phase 1 · completed
NCT06772246 — A Study to Evaluate QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart Rate · Phase 1 · completed
NCT06740799 — Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment · Phase 1 · recruiting

Other recruiting trials for AML

Currently open trials in the same condition.

NCT06611839 — Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML · Phase 1, PHASE2 · recruiting
NCT07163728 — Leptin: A Marker for AML Chemo-Sensitivity · recruiting
NCT06973668 — A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophospham · Phase 2 · recruiting
NCT07126782 — The Efficacy and Safety Assessment of Allogeneic γδ T Cells in Patients With MRD-positive AML After Allo-HSCT · EARLY_PHASE1 · recruiting
NCT06717958 — Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute M · Phase 2 · recruiting

Other The University of Hong Kong trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03135054 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The University of Hong Kong
Last refreshed: 10 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03135054.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing