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OncoMatch/Clinical Trials/NCT06578247

Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

Is NCT06578247 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Quizartinib and Chemotherapy for leukemia.

Phase 3RecruitingDaiichi SankyoNCT06578247Data as of May 2026

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).

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

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)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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 →

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