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

Key Inclusion Criteria:

• Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)-or Institutional Review Board (IRB)-approved Informed Consent Form (ICF) beforeperformance of any trial-specific procedures or tests.

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

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

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

• Participant is receiving standard "7+3" induction chemotherapy regimen as specifiedin the protocol

Key Exclusion Criteria:

• 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).

• Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasmsor autoimmune/rheumatologic conditions.

• Diagnosis of AML secondary to myelodysplastic syndrome (MDS) or a myeloproliferativeneoplasm (MPN) or MDS/MPNs including CMML, aCML, JMML and others.

• 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.

• Prior treatment for AML, except for the following allowances:

1. Leukapheresis;

2. Treatment for hyperleukocytosis with hydroxyurea;

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

4. Prophylactic intrathecal chemotherapy;

5. Growth factor/cytokine support.