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 a combination of medications, including Midostaurin, Gemtuzumab Ozogamicin, Cytarabine, and Daunorubicin Hydrochloride. These medications are used in different forms, such as soft capsules and solutions for infusion, which are administered intravenously or orally.
The purpose of the study is to evaluate how well the combination of Midostaurin and Gemtuzumab Ozogamicin works when used with standard chemotherapy for treating newly diagnosed AML. Participants will receive these treatments as part of their first-line therapy, which means it is the first set of treatments given for their condition. The study will monitor the tolerability, which refers to how well patients can handle the treatment, and the efficacy, which means how effective the treatment is in managing the disease.
Throughout the study, participants will receive the medications in a structured manner, with some receiving a placebo for comparison. The trial will assess the maximum tolerated dose of the medications and track the event-free survival of participants, which is the time they remain free from treatment failure, relapse, or death. The study aims to provide valuable insights into the potential benefits of this combination therapy for patients with AML.
Germany 
