This study aims to evaluate the effectiveness of new treatment combinations for patients with newly diagnosed Acute Myeloid Leukemia, which is a type of cancer that affects the blood and bone marrow. The research focuses on specific subtypes of this disease characterized by certain genetic changes, specifically NPM1 mutations or KMT2A rearrangements. These changes are specific alterations in the DNA of the cancer cells that influence how the disease behaves.
The research involves two different approaches to treatment. In the first approach, ziftomenib is used alongside a nonintensive therapy consisting of venetoclax and azacitidine. In the second approach, ziftomenib is combined with an intensive therapy known as 7+3, which includes cytarabine and daunorubicin hydrochloride. Some participants may receive a placebo instead of ziftomenib to allow for a comparison between the different treatment methods.
During the study, participants will receive their assigned medications through different methods, such as oral pills or intravenous administration, which is the delivery of medicine directly into a vein. The study will monitor how long patients live and the time until the disease begins to grow again. This process helps determine if adding the new drug to standard treatments improves the long-term outcomes for people with these specific genetic forms of leukemia.
Belgium 
Czechia 
France 
Germany 
Greece 
Hungary 
Italy 
Poland 
Portugal 
Spain 
