This study involves patients over 55 years of age with Acute Myeloid Leukemia, also known as AML, which is a type of cancer that affects the blood and bone marrow where blood cells are made. The patients in this study have a specific change in their genes called an IDH1 mutation. All participants must be in complete remission, meaning their cancer is no longer detectable after receiving intensive chemotherapy, which is a strong treatment using powerful medicines to kill cancer cells. The study will use two medications given by mouth: azacitidine, which is also known by the brand name Onureg, and ivosidenib, which is also known as Tibsovo. Both medications are tablets that patients will take orally.
The purpose of the study is to evaluate how long patients remain free from their cancer coming back when they receive both azacitidine and ivosidenib together. The study will look at whether this combination of medications can help keep the cancer from returning for 24 months. During the study, patients will receive the combination treatment for up to 24 months. The study will monitor how well the treatment works and watch for any unwanted effects that might occur. Doctors will also check the blood and bone marrow regularly to see if there are any signs of the cancer returning.
Throughout the study, patients will have regular check-ups and tests to assess their health and the status of their disease. Blood tests will be performed to monitor organ function, including the kidneys and liver, and to check blood cell counts. The study will track various outcomes including how long patients survive without their cancer returning, overall survival rates, and whether any signs of disease can be detected in the blood or bone marrow using special laboratory tests. Any side effects or health problems that occur during treatment will be carefully recorded and evaluated according to standard medical classifications.



France