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

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 anytrial-specific procedures or tests.

2. ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (atScreening).

3. Newly diagnosed, morphologically documented primary AML based on the World HealthOrganization (WHO) 2016 classification (at Screening)

4. Eastern Cooperative Oncology Group (ECOG) performance status (at the time theparticipant signs their ICF) of 0-2.

5. Participant is a candidate for standard "7+3" induction chemotherapy regimen asspecified in the protocol per investigator assessment

Key Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia (APL), French-American-Britishclassification M3 or WHO classification of APL with translocation,t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia inblast crisis); participants who undergo diagnostic workup for APL and treatment withall-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 amyeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocyticleukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocyticleukemia (JMML) and others.

4. Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD [+]) presentat ≥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 ofchemotherapy:

6. Leukapheresis;

7. Treatment for hyperleukocytosis with hydroxyurea;

8. Cranial radiotherapy for central nervous system (CNS) leukostasis;

9. Prophylactic intrathecal chemotherapy