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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Acute Myeloid Leukemia
Date of first enrollment	19/02/2025
Target sample size	700
Countries of recruitment	Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Croatia,Japan,Czech,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hong Kong,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Serbia,Japan,Singapore,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,Taiwan,Japan,Ukraine,Japan,United Kingdom,Japan,United States,Japan
Study type	Interventional
Intervention(s)	Experimental: Arm A: Quizartinib + Chemotherapy (Cytarabine, Daunorubicin or Idarubicin) Participants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive quizartinib at 60 mg/day orally once daily for up to 36 cycles (28-day cycle). Placebo Comparator: Arm B: Placebo + Chemotherapy (Cytarabine, Daunorubicin or Idarubicin) Participants will receive placebo at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle) Experimental: Arm C: Quizartinib + Chemotherapy (Cytarabine, Daunorubicin or Idarubicin) then Placebo Maintenance Participants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)

Outcome(s)

Primary Outcome	Efficacy: Overall survival (OS)
Secondary Outcome	Efficacy: Event-free survival (EFS), Duration of complete response (DoCR), Relapse-free survival (RFS), Complete remission rate (CR), CR rate with minimal or measurable residual disease (MRD) Safety and tolerability: Treatment-emergent adverse events (TEAE)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 70age old
Gender	Both
Include 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) before performance of any trial-specific procedures or tests. - >=18 years or the minimum legal adult age (whichever is greater) and <=70 years (at Screening). - Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening) - Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2. - Participant is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol
Exclude criteria	- 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). - Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms or autoimmune/rheumatologic conditions. - Diagnosis of AML secondary to myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including CMML, aCML, JMML and others. - 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. - 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.