This clinical trial is focused on studying treatments for Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The study involves several medications, including Cytarabine, Mitoxantrone, Fludarabine Phosphate, Etoposide, Prednisolone Sodium Succinate, Daunorubicin Hydrochloride, Gemtuzumab Ozogamicin, Methylprednisolone, Hydrocortisone, Methotrexate, and Dexrazoxane. These medications are used in various forms, such as solutions for injection or infusion, and are administered intravenously, which means they are given directly into a vein.

The purpose of this study is to improve the overall event-free survival for children and adolescents who have been newly diagnosed with AML. The study will explore whether adding Gemtuzumab Ozogamicin to the first course of treatment can enhance early anti-leukemic effects in patients with a specific type of AML known as CD33-positive. Additionally, the study will compare the effectiveness of two versus three courses of consolidation therapy, which is a phase of treatment aimed at maintaining remission, in patients who are considered to be at standard risk.

Participants in the study will receive different combinations of the medications mentioned above, depending on their specific treatment plan. The study will monitor the participants’ response to the treatment over time, focusing on their event-free survival, which refers to the length of time they remain free from certain complications or events related to their disease. The study will also assess the safety and side effects of the treatments. The trial is expected to continue until 2036, with recruitment having started in August 2023.