Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
← catalyst calendarNCT06578247 · readout in 1,406 d
Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
700estimated
Sites
284
Countries
Australia, Austria, Belgium +25
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-11-19 | actual | When the study began enrolling |
| Primary completion | 2030-06-26 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-06-26 | estimated | The whole study's end, after follow-up |
| First posted | 2024-08-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Leukemia
Interventions
- Drug: Quizartinib — also filed as Test Product
- Drug: Placebo — also filed as Placebo Control
- Drug: Chemotherapy — also filed as Cytarabine, Daunorubicin or Idarubicin, Standard Chemotherapy
Primary outcome
what the primary-completion date above is the date OFOverall Survival (Arm A vs Arm B)
measured Date of first patient randomized to the target number of deaths reached, up to approximately 42 months
Publications
- PMID 42434847 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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