Before starting treatment, your medical history will be reviewed and tests will be performed to confirm eligibility for the study.

Blood tests will be performed to check kidney and liver function, as well as blood cell counts.

A heart function test will be performed using an echocardiogram or MUGA scan to ensure your heart is functioning adequately.

A pregnancy test will be required if applicable.

The presence of an NPM1 mutation in your leukemia cells will be confirmed through laboratory testing.

Your white blood cell count must be reduced to acceptable levels before starting the study treatment. Medications such as hydroxyurea or a single dose of cytarabine may be used to achieve this.

Once all tests are completed and eligibility is confirmed, you will be randomly assigned to receive either revumenib or placebo in combination with intensive chemotherapy. Neither you nor your doctor will know which group you are assigned to.

This phase begins on Day 1 of the first cycle and is designed to reduce leukemia cells in your body.

You will receive intensive chemotherapy consisting of daunorubicin hydrochloride or idarubicin hydrochloride combined with cytarabine. These medications will be given through a vein.

Starting on Day 8 of the first cycle, you will begin taking either revumenib tablets or placebo tablets by mouth. The specific dose and frequency will be determined by your doctor.

You will continue taking the tablets daily as instructed throughout this cycle.

Regular blood tests will be performed to monitor your blood cell counts, kidney function, liver function, and other important health markers.

Your bone marrow will be tested to assess the response to treatment and check for measurable residual disease, which refers to small amounts of leukemia cells that may remain.

Depending on your response to the first induction cycle, you may receive additional cycles of intensive chemotherapy.

Each cycle will include chemotherapy given through a vein, similar to the first cycle.

You will continue taking the assigned tablets (either revumenib or placebo) by mouth daily throughout these cycles.

Bone marrow tests will be repeated to assess whether you have achieved complete remission, which means that leukemia cells are no longer detectable in your bone marrow and blood counts have returned to normal levels.

Blood tests will continue regularly to monitor your overall health and detect any side effects from the treatment.

Throughout the study, you will have regular appointments to monitor your condition and assess the effectiveness of the treatment.

Blood samples will be collected periodically to check for measurable residual disease using molecular testing methods.

Your doctor will monitor you for any side effects or complications from the treatment, including changes in blood cell counts, kidney function, liver function, heart function, and overall well-being.

Your performance status will be assessed regularly to determine how well you are able to carry out daily activities.

The duration of your participation in the study will depend on your response to treatment and whether the leukemia returns.

If you achieve complete remission, you will continue to be monitored for signs of relapse, which is when leukemia cells return after treatment.

After completing the active treatment phase, you will enter a long-term follow-up period.

During this time, your doctor will continue to monitor your health status and check for any signs that the leukemia has returned.

The study will track important outcomes such as event-free survival, which measures the time from the start of treatment until treatment failure, relapse, or death, and overall survival, which measures the time from the start of treatment until death from any cause.

Information about any side effects that occur during or after treatment will be collected and recorded.

Your participation in the follow-up phase will help determine the long-term effectiveness and safety of the treatment approach used in this study.