This clinical trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML), specifically in children who have a mutation known as FLT3. The study is testing a treatment that combines a medication called midostaurin (also known by its code name PKC412) with standard chemotherapy. Chemotherapy is a common cancer treatment that uses drugs to kill cancer cells. The study aims to understand how safe and effective this combination is, as well as how the body processes midostaurin.
Participants in the study will receive midostaurin twice a day along with chemotherapy drugs such as cytarabine, etoposide, idarubicin, daunorubicin, mitoxantrone, and fludarabine. These drugs are given through a vein, which is known as intravenous use. After the initial treatment phase, participants will continue to receive midostaurin alone for a period to see if it helps keep the cancer from coming back. The study will monitor the safety of the treatment by checking for any side effects and how well the participants tolerate the medication.
The purpose of this study is to evaluate the safety and tolerability of midostaurin when used in combination with chemotherapy and as a standalone treatment after the initial therapy. The study will also look at how well the treatment works in reducing the cancer and preventing it from returning. Participants will be closely monitored throughout the study to ensure their safety and to gather information on how the treatment affects their health. The study is expected to continue until the end of 2029.



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