This clinical trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML) that has a specific genetic change known as the FLT3 mutation. The study is for patients who have been newly diagnosed with this condition and are not able to undergo intensive chemotherapy. The trial is testing the effectiveness of a medication called Gilteritinib, also known by its code name ASP2215, both on its own and in combination with another medication called Azacitidine. Azacitidine is also being tested alone to see how it compares to the other treatments.
The purpose of the study is to find out which treatment option helps patients live longer. Participants in the study will be randomly assigned to receive either Gilteritinib, a combination of Gilteritinib and Azacitidine, or Azacitidine alone. The study will monitor the participants over a period to observe their overall health and how well they respond to the treatment. The study will also look at other factors such as how long patients remain free of leukemia and their quality of life during the treatment.
Throughout the study, participants will have regular check-ups, including blood tests and other assessments, to ensure their safety and to gather information on how the treatments are working. The study aims to provide valuable insights into the best treatment options for patients with this specific type of leukemia who cannot undergo more aggressive chemotherapy treatments.
Belgium 
Germany 
