AC220-167: Evaluating different doses of a medicine called quizartinib in people with acute myeloid leukaemia who are in complete remission after induction therapyA Phase 2, Multicenter, Randomized, Open-label Trial to Evaluate Safety and Efficacy of Two Dose Levels of Quizartinib as Maintenance for Adult Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia in Complete Remission

Exclusion

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 (i.e., 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 for other neoplasms.

3. Prior treatment for AML, except for the following allowances:

   1. Induction and consolidation therapy, as previously described (inclusion criterion #5)
   2. Leukapheresis
   3. Hydroxyurea to treat hyperleukocytosis
   4. Cranial radiotherapy for central nervous system (CNS) leukostasis
   5. Prophylactic intrathecal chemotherapy
   6. Growth factor/cytokine support
4. Participant had received allo-HSCT as part of AML treatment.
5. Treatment with any strong or moderate CYP3A inducers within 2 weeks or 5 half-lives of randomization whichever is longer

6. Uncontrolled or significant cardiovascular disease, including the following:

   1. QTcF interval >450 ms (based on average of triplicate ECG at Screening)
   2. Diagnosed or suspected congenital long QT syndrome or known family history of congenital long QT syndrome
   3. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes
   4. Participant has bradycardia of less than 50 beats per minute (bpm; as determined by central reading), unless the participant has a pacemaker
   5. History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers.
   6. Myocardial infarction within 6 months prior to screening
   7. Uncontrolled angina pectoris within 6 months prior to screening
   8. New York Heart Association Class 3 or 4 congestive heart failure
   9. LVEF ≤45% or institutional lower limit of normal
   10. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg despite optimal medical management)
   11. Complete left or right bundle branch block
   12. Severe aortic stenosis