Study of Ivosidenib or Enasidenib with Chemotherapy for Patients with Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome with IDH1 or IDH2 Mutation

This clinical trial is focused on studying treatments for patients who have been newly diagnosed with either acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). These are types of blood cancers that affect the bone marrow, where blood cells are made. The study is specifically for patients whose cancer cells have a mutation in the IDH1 or IDH2 genes. These mutations can affect how the cancer grows and responds to treatment.

The trial will test two medications, ivosidenib and enasidenib, which are taken as film-coated tablets. These medications are designed to target the specific gene mutations in the cancer cells. The study will compare the effects of these medications when used alongside standard chemotherapy treatments. Some patients will receive a placebo instead of the active medication to help researchers understand the true effects of the drugs being tested.

The purpose of the study is to see if these treatments can improve the time patients live without the cancer getting worse, known as event-free survival. Participants will go through different phases of treatment, including induction therapy, consolidation therapy, and maintenance therapy. These phases are designed to first reduce the number of cancer cells, then stabilize the condition, and finally maintain the results over time. The study aims to provide valuable information on how effective these treatments are for patients with these specific gene mutations in AML or MDS.