Adults 18 to 80, any sex, with Leukemia, Myeloid, Acute. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With Treatment Related Adverse Events After Taking CPX-351 and QuizartinibPrimary· Collected during treatment and for 30 days after last dose, approximately 35 total days for the 1 patient treated.
Counting the number of patients with treatment related adverse events as a measure of safety and tolerability.
Group
Value
95% CI
CPX-351 and Quizartinib Treatment
1
Overall Survival (OS)Secondary· Up to 8 months
Overall survival is defined as the time from the first date of treatment until death as a result of any cause. For OS time, patients that have not died or are lost to follow-up will be censored at the date the patient was last known to be alive or the date of last contact.
Group
Value
95% CI
CPX-351 and Quizartinib Treatment
7.7
Number of Patients Who Can Receive Consolidation and Maintenance TherapySecondary· approximately 3 months
Patients who proceed through induction to next stages of consolidation and maintenance
Group
Value
95% CI
CPX-351 and Quizartinib Treatment
0
Treatment-related Mortality RateSecondary· Observed during treatment and for 30 days after last dose, so approximately 35 days for the 1 patient treated.
As determined by the number of treatment related deaths during study treatment
Group
Value
95% CI
CPX-351 and Quizartinib Treatment
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Collected for 30 days after last dose, so approximately 35 days for the 1 patient treated..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a research study to be done at multiple sites in participants with advanced acute myeloid leukemia (AML) that have a mutation in Fms-like tyrosine kinase-3 internal tandem duplications (FLT3-ITD). This study is to learn more about an investigational drug, quizartinib, being tested with the anti-cancer medicine CPX-351 (also called Vyxeos™), which is approved and widely used to treat AML.
The purpose of this study is to assess the safety, tolerability and survival of patients receiving the combination of CPX-351 and quizartinib.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07008638 — Phase I/II Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53-
· Phase 1, PHASE2
· recruiting
NCT05829434 — Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS
· Phase 2
· withdrawn
NCT04982354 — Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
· Phase 1, PHASE2
· withdrawn
NCT04992949 — Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm
· Phase 2
· completed
NCT05169307 — CPX-351 Real-World Effectiveness and Safety Study
· completed
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Trials by the same sponsor.
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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 SCRI Development Innovations, LLC
Last refreshed: 5 December 2023
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/NCT04209725.