Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission

Inclusion criteria

• ✓. Adults ≥18 years of age or the minimum legal adult age (whichever is greater) on the day of signing the ICF (no upper limit of age).
• ✓. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008/2016 classification.
• ✓. Participant has confirmed FLT3-ITD-positive (≥0.05 SR or ≥5% VAF) activating mutation from initial diagnosis in bone marrow or peripheral blood as determined by a local institution's validated molecular testing.
• ✓. Participants must have confirmed, morphologically documented CR1, on the most recent BMA, based on the local laboratory results, performed within 28 days prior to C1D1 of maintenance therapy. Complete remission will be defined as \<5% blasts in the bone marrow with no morphologic characteristics of acute leukemia (e.g., Auer Rods), no evidence of extramedullary disease, and no leukemic blasts in the peripheral blood.
• ✓. Participant must meet the following prior therapy requirements:
• ✓. Has received at least one cycle of induction therapy but no more than two to achieve CR1. The induction cycles can be the same regimen or different regimens and may contain conventional agents only (e.g., cytarabine + daunorubicin or idarubicin: "7 + 3" or "5 + 2"), or a combination with FLT3 inhibitors.
• ✓. Has not received more than four cycles of consolidation therapy. Regimens may contain conventional agents only.
• ✓. FLT3 inhibitors are permitted as part of the induction or consolidation treatment.

Exclusion criteria