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Comparing Quizartinib with Placebo in Treating Acute Myeloid Leukemia

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

Phase 3 Interventional Daiichi Sankyo · NCT06578247

This study is testing if adding quizartinib to standard chemotherapy can help adults with newly diagnosed acute myeloid leukemia live longer compared to just chemotherapy with a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorDaiichi Sankyo Industry-sponsored
Drugs / interventionschemotherapy, Quizartinib
Locations288 sites (Goodyear, Arizona and 287 other locations)
Trial IDNCT06578247 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of quizartinib in combination with standard chemotherapy compared to a placebo plus chemotherapy in adults with newly diagnosed FLT3-ITD negative acute myeloid leukemia (AML). Participants will receive standard induction and consolidation chemotherapy, followed by quizartinib or placebo as maintenance therapy for up to 36 cycles. The primary goal is to assess overall survival rates among the participants. Central laboratory testing will confirm FLT3-ITD mutation status prior to enrollment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with newly diagnosed FLT3-ITD negative acute myeloid leukemia.

Not a fit: Patients with acute promyelocytic leukemia or BCR-ABL positive leukemia will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve overall survival rates for patients with FLT3-ITD negative AML.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating acute myeloid leukemia, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved ICF before performance of any trial-specific procedures or tests.
2. ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening).
3. Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
4. Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
5. Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment

Key Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy.
3. Diagnosis of AML with known antecedent myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and others.
4. 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.
5. Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy:

   1. Leukapheresis;
   2. Treatment for hyperleukocytosis with hydroxyurea;
   3. Cranial radiotherapy for central nervous system (CNS) leukostasis;
   4. Prophylactic intrathecal chemotherapy

Where this trial is running

Goodyear, Arizona and 287 other locations

+238 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Leukemiaacute myeloid leukemiaquizartinibFLT3FLT3-ITDChemotherapyFLT3-WT
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.