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Olutasidenib, Venetoclax, and Azacitidine for the Treatment of Newly Diagnosed IDH1 Mutated Acute Myeloid Leukemia

Trial Status: active

This phase II trial tests the safety and side effects of olutasidenib, venetoclax, and azacitidine and how well they work in treating patients with newly diagnosed isocitrate dehydrogenase 1 mutant-positive (IDH1m+) acute myeloid leukemia (AML). AML is a blood cancer and patients with an IDH1 mutation have poorer outcomes. IDH1 mutations make cancer cells more resistant to treatment. Olutasidenib blocks the protein made by the mutated IDH1 gene. Blocking this protein may help keep cancer cells from growing. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Azacitidine, a type of antimetabolite, is a drug that is used to treat myelodysplastic syndromes and is being studied in the treatment of other types of cancer. It stops cells from making deoxyribonucleic acid and may kill cancer cells. Giving olutasidenib, venetoclax, and azacitidine may be safe, tolerable, and/or effective in treating patients with newly diagnosed IDH1m+ AML.