This study investigates the safety and effectiveness of using DNA methyltransferase inhibitors (DMTi) before chemotherapy in treating children with acute myeloid leukemia (AML). DNA methyltransferase inhibitors are substances that may help in modifying the genes' activity without changing the DNA sequence itself. The purpose is to see if these inhibitors can make the chemotherapy treatment work better by preparing the body to respond more effectively to the drugs.
During this study, participants will receive either azacitidine or decitabine before the usual chemotherapy regimen. These are types of DMTi that might help in changing how the cancer cells grow and divide. The study will compare the effects of these two treatments to understand which one may offer better outcomes for children with AML.
- Who can participate: Children diagnosed with acute myeloid leukemia, myeloid sarcoma, or high-grade myelodysplastic syndrome with more than 5% blasts can participate. Participants must not have received prior therapy for this malignancy, except for specific exceptions like hydroxyurea. Those with Down syndrome or other specified conditions are excluded.
- Study details: Participants will receive either azacitidine or decitabine before their standard chemotherapy regimen. A placebo is not used in this study, as all participants receive active treatment. Participants must adhere to contraceptive guidelines during and after the study.
