Study on Olutasidenib, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia with IDH1 Mutation

Inclusion Criteria

• Adults aged 18 to 75 years who can undergo intensive chemotherapy.
• Good overall health with an ECOG performance status of 0 to 2.
• Newly diagnosed with AML that has an IDH1 mutation, or secondary AML with prior treatment for related blood disorders.
• Adequate organ function, including liver and kidney function within specified limits.
• At least 7 days since any previous treatment for blood disorders before starting the study treatment.
• Recovery from any previous treatment side effects to a mild level.
• Heart rhythm within normal limits, unless a specific heart condition is present.
• Women of childbearing potential must have a negative pregnancy test and use effective birth control during the study and for 3 months after.
• Men and women must agree not to donate eggs or sperm during the study and for 3 months after.
• Willingness to participate and provide informed consent.

Exclusion Criteria

• AML that has returned or not responded to previous treatment.
• Certain types of AML with favorable risk, except for specific mutations.
• Acute promyelocytic leukemia (APL).
• Specific genetic mutations not allowed.
• Active leukemia in the central nervous system.
• Under 18 or over 75 years old.
• Pregnant or breastfeeding women.
• Plans to become pregnant or father a child during or shortly after the study.
• Allergies to study drugs.
• Previous treatment with similar drugs.
• Unstable medical conditions that could increase risk.
• Recent use of certain medications that affect drug metabolism.
• History of stem cell transplant with active complications.
• Other active cancers under treatment.
• Active hepatitis B, C, or HIV infection.
• Recent major surgery without full recovery.
• Impaired decision-making capacity.