Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood
← catalyst calendarNCT03793478 · readout in 255 d
Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →. With Innovative Therapies For Children with Cancer Consortium, Children's Oncology Group.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
65estimated
Sites
27
Countries
Belgium, Canada, Denmark +7
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 | 2018-08-15 | actual | When the study began enrolling |
| Primary completion | 2027-05-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-05-01 | estimated | The whole study's end, after follow-up |
| First posted | 2019-01-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Acute Myeloid Leukemia
Interventions
- Drug: Quizartinib — also filed as Quizartinib dihydrochloride, Vanflyta
- Drug: Fludarabine
- Drug: Cytarabine
- Drug: Intrathecal (IT) triple chemotherapy prophylaxis
- Drug: Etoposide
Primary outcomes
what the primary-completion date above is the date OFNumber of dose-limiting toxicities (Phase 1)
measured Re-induction Cycle 1 Day 1 up to Day 28 (each cycle is 28 days)
Composite complete remission (CRc) rate among participants with acute myeloid leukemia (AML) (Phase 1 and 2)
measured within 8 years, 8 months
Pharmacokinetic parameter area under the concentration curve for quizartinib and AC886 (Phase 1 and 2)
measured Re-induction Phase 1 and 2,Cycle 1: Days 6, 20:Predose, 1 hour (Phase 1 only), 2, 4, and 6 hours; Days 7 and 21:24 hours; Phase 1 and 2 Cycle 2: Days 6 and 20:predose, 3 hours; Continuation Cycle 1 Days 1 and 15:predose, 2-4 hours (each cycle, 28 days)
Pharmacokinetic parameter apparent clearance (CL/F) for quizartinib and AC886 (Phase 1 and 2)
measured Re-induction Phase 1 and 2,Cycle 1: Days 6, 20:Predose, 1 hour (Phase 1 only), 2, 4, and 6 hours; Days 7 and 21:24 hours; Phase 1 and 2 Cycle 2: Days 6 and 20:predose, 3 hours; Continuation Cycle 1 Days 1 and 15:predose, 2-4 hours (each cycle, 28 days)
Pharmacokinetic parameter apparent volume of distribution (Vz/F) for quizartinib and AC886 (Phase 1 and 2)
measured Re-induction Phase 1 and 2,Cycle 1: Days 6, 20:Predose, 1 hour (Phase 1 only), 2, 4, and 6 hours; Days 7 and 21:24 hours; Phase 1 and 2 Cycle 2: Days 6 and 20:predose, 3 hours; Continuation Cycle 1 Days 1 and 15:predose, 2-4 hours (each cycle, 28 days)
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