Treatment for acute myeloid leukemia (AML) involves high doses of a common class of chemotherapy drugs called anthracyclines. One anthracycline drug which is effective in treating AML is daunorubicin, but high doses are known to cause long-term side effects, especially to the heart. (Side effects are unintended and unwanted results of treatment.) Study doctors are interested in finding an effective treatment for AML patients that reduces the potential for long-term side effects.
   
This study will compare standard chemotherapy using daunorubicin, cytarabine and gemtuzumab ozogamicin (GO) to chemotherapy using an experimental drug called CPX-351. CPX-351 is made up of daunorubicin and cytarabine. CPX-351 (also called Vyxeos®) is approved by the Food and Drug Administration (FDA) for the treatment of adults with newly diagnosed AML related to treatment for another cancer or AML with myelodysplastic features. It is not approved for use in children or young adults with newly diagnosed AML. CPX-351 is made in a way that could be less likely to cause heart problems than traditional anthracycline drugs. Part of this study is to compare effects of all therapies on the heart. All patients on this study will have tests to check heart function during study treatment and follow-up.
   
Researchers also want to find out the dose and effectiveness of a different investigational drug, called gilteritinib. Some AML patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. The drug gilteritinib has been shown to block the abnormal function of the FLT3 gene that makes cancer cells grow. Gilteritinib is FDA approved for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation. It is not yet approved for treatment in children. Subjects will be tested to see if their AML has high levels of FLT3/ITD or other mutations. If so, potential subjects may be invited to participate in a separate arm of this study which will include the use of gilteritinib.
   
Other goals of this study include studying changes in brain function during and after treatment for AML and to understand the biology of AML and treatment.