Upon joining the study, your physical condition will be assessed using the ECOG performance status, which is a scale from 0 to 2 that measures how the disease affects your daily living abilities.

Blood samples will be collected to check your clinical laboratory values and ensure they meet the required criteria for participation.

If you are a female of childbearing potential, a pregnancy test will be performed at this stage and again within 48 hours before receiving the first dose of the study medication.

You will receive bleximenib, which is also referred to as JNJ-75276617. This medication is an investigational drug that works by blocking the interaction between two proteins involved in the growth of leukemia cells.

The medication is administered by oral use, meaning you will take it by mouth.

The medication is available in several forms: tablets, film-coated tablets, capsules, or powder for oral solution.

The specific dose and dosing schedule will be determined based on the phase of the study you are enrolled in.

If you are participating in this part, the dose of bleximenib will be gradually increased to determine the recommended phase 2 dose, which is the dose that will be used in later parts of the study.

During this phase, you will be closely monitored for any side effects or adverse events, particularly dose-limiting toxicity, which refers to serious side effects that prevent further dose increases.

The frequency and severity of any adverse events will be recorded and assessed.

If you are participating in this part, you will receive bleximenib at the recommended phase 2 dose that was determined in the previous phase.

The primary focus during this phase is to further evaluate the safety and tolerability of the medication at this specific dose.

Your health status and any side effects will continue to be monitored and documented.

If you are participating in this phase, you will receive bleximenib at the recommended phase 2 dose.

This phase is specifically for individuals with acute myeloid leukemia that has specific genetic alterations, either KMT2A rearrangements or NPM1 mutations.

The main goal of this phase is to evaluate how well the medication works in treating your condition.

The effectiveness will be measured by the rate of complete remission or complete remission with partial hematologic recovery, which means the leukemia is no longer detectable or blood counts have partially recovered. This will be assessed by an independent review committee.

Throughout your participation, regular monitoring will be conducted to track your response to the treatment and to identify any adverse events.

Blood tests and other clinical assessments will be performed at scheduled intervals.

Any side effects or changes in your health status will be documented and evaluated by the study team.

The study is estimated to continue until March 2026.

Your individual participation duration will depend on how you respond to the treatment and whether you experience any significant side effects.

Final assessments will be conducted at the end of your participation to evaluate the overall outcomes.