CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 700 target
Drug / intervention
Quizartinib +2 moredrug
Likely dose
Quizartinib 60 mgfrom record
Key inclusion· 5
  • ✓Age 18 to 70 years at screening
  • ✓Newly diagnosed, morphologically documented primary AML per WHO 2016 classification
  • ✓ECOG performance status 0-2
  • ✓Candidate for standard 7+3 induction chemotherapy per investigator assessment
Key exclusion· 6
  • ✕Acute promyelocytic leukemia (APL) with t(15;17) translocation
  • ✕BCR-ABL positive leukemia (chronic myelogenous leukemia in blast crisis)
  • ✕AML secondary to prior chemotherapy or radiotherapy
  • ✕AML with antecedent myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06578247
NCT06578247Phase 3RecruitingOn TrackUpdated 2mo ago
CompareCT.gov

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia

Daiichi Sankyo·interventional·Posted Aug 29, 2024·Updated Apr 30, 2026

In Brief

A Phase 3 clinical trial evaluating Quizartinib, Placebo, and 1 other intervention for Leukemia. Currently recruiting, targeting 700 participants across 288 sites in 28 countries.

Detailed Summary

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesAustralia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, France, Germany, Hong Kong, Hungary, Italy, Japan, Norway, Poland, Portugal, Romania, Serbia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3Recruiting
202520262027202820292030
First PostedAug 29, 2024
Enrollment StartNov 19, 2024
Primary CompletionJun 26, 2030
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 1.8 years agoPrimary completion in 4.0 years

Interventions

Quizartinibdrug

Participants will receive quizartinib at 60 mg/day orally once daily

Placebodrug

Participants will receive placebo at 60 mg/day orally once daily

Chemotherapydrug

Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).