Brief Summary
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acutenew, recent, comes with an urgent or significant sense, is sudden, sharp myeloid leukemia (AML).
Intervention / Treatment
- Drug: Quizartinib
- Drug: Placebo
- Drug: Chemotherapy
Inclusion Criteria:
- 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.
- ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening).
- Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
- Participant is a candidate for standard “7+3” induction chemotherapy regimen as specified in the protocol per investigator assessment