OncoMatch/Clinical Trials/NCT06578247
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
Is NCT06578247 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Quizartinib and Chemotherapy for leukemia.
Treatment: Quizartinib · Chemotherapy — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Biomarker criteria
Required: FLT3 ITD mutation at ≥5% VAF (or ≥0.05 SR) (negative)
Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD [+]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay [excluded]
Required: BCR ABL fusion (negative)
BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis) [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: any AML therapy
Exception: leukapheresis, hydroxyurea for hyperleukocytosis, cranial radiotherapy for CNS leukostasis, prophylactic intrathecal chemotherapy
Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy: Leukapheresis; Treatment for hyperleukocytosis with hydroxyurea; Cranial radiotherapy for central nervous system (CNS) leukostasis; Prophylactic intrathecal chemotherapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Phoenix · Goodyear, Arizona
- Mayo Clinic - Phoenix · Phoenix, Arizona
- University of Arizona Cancer Center · Tucson, Arizona
- David Geffen School of Medicine · Los Angeles, California
- University of California Davis Health System · Sacramento, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06578247 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require FLT3?
Yes, FLT3 ITD mutation at ≥5% VAF (or ≥0.05 SR) is a required biomarker for enrollment.
Does this trial require BCR?
Yes, BCR ABL fusion is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify