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A Study Testing Bleximenib in People with Acute Leukemia

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying acute leukemia, which is a type of blood cancer that develops quickly and affects the blood and bone marrow. The treatment being tested is bleximenib, also known by its code name JNJ-75276617. This medication is given by mouth and comes in different forms including tablets, capsules, and powder that can be mixed into a liquid solution. The study is specifically looking at people whose acute leukemia has certain genetic changes, including alterations in genes called KMT2A, NPM1, or nucleoporin genes.

The purpose of this study is to find out if bleximenib is safe and effective for treating acute leukemia. In the first phase of the study, researchers will determine the best dose of the medication to use and will check for any side effects. In the second phase, they will test how well the medication works at the recommended dose by measuring whether it can help patients achieve complete remission, which means that signs of the disease are no longer detectable.

The study has different parts. During the dose escalation part, doctors will test different amounts of bleximenib to find the safest and most effective dose. In the dose expansion part, more patients will receive the recommended dose to gather additional information about safety. Throughout the study, participants will be closely monitored for any unwanted effects and to see how their leukemia responds to treatment. The study is open to adults aged 18 years and older, as well as adolescents between 12 and 17 years of age in certain parts of the trial. Participants must have acute leukemia that has come back after previous treatment or has not responded to other therapies, and their leukemia must have specific genetic features that the medication is designed to target.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and baseline evaluation

    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.

  2. Step 2

    Treatment with bleximenib

    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.

  3. Step 3

    Phase 1, part 1: dose escalation

    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.

  4. Step 4

    Phase 1, part 2: dose expansion

    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.

  5. Step 5

    Phase 2: efficacy evaluation

    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.

  6. Step 6

    Ongoing monitoring throughout the study

    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.

  7. Step 7

    Study completion

    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.

Who can join the trial?

6 criteria

  • You must be at least 18 years of age for most study groups, or between 12 and less than 18 years of age for the adolescent group
  • You must have acute leukemia, which is a type of blood cancer, that has come back after treatment or has not responded to treatment, and you have tried all available treatment options or are not suitable for them
  • Your leukemia must have specific genetic changes called KMT2A, NPM1, or nucleoporin alterations. These are changes in your genes that affect how your cancer cells grow. In the second phase of the study, only patients with KMT2A-r or NPM1 mutations can participate
  • Your blood test results must meet certain requirements that show your organs are working well enough for the study
  • Your ECOG performance status must be 0, 1, or 2. This is a score that measures how well you can perform daily activities, where 0 means you are fully active and 2 means you can care for yourself but cannot work
  • If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study treatment

Who cannot join the trial?

9 criteria

  • The study does not list specific exclusion criteria in the provided information, which means detailed reasons why patients cannot participate are not available in this data
  • Generally, clinical trials have standard exclusion criteria that may include conditions that could affect patient safety or study results
  • Patients should discuss with their doctor whether they meet the requirements to participate in this study
  • The doctor will review all medical history and current health conditions to determine if participation is appropriate
  • Certain medications, other health problems, or recent treatments may prevent participation in the study
  • Pregnancy or plans to become pregnant during the study period may be a reason for exclusion
  • Severe organ problems affecting the heart (the organ that pumps blood), liver (the organ that cleans the blood), or kidneys (the organs that filter waste from blood) may prevent participation
  • Active infections or other cancers may be reasons why a patient cannot join the study
  • Previous severe reactions to similar medications may be a reason for exclusion
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Investigated drugs

Bleximenib is an experimental medication being tested in this study. It works by blocking the interaction between two proteins called menin and KMT2A (also known as MLL1). This blocking action may help stop the growth of leukemia cells. Bleximenib is being studied to see if it is safe and effective for treating people with acute leukemia, which is a type of blood cancer.

What is already known about the treatment

Bleximenib – Bleximenib is an experimental medication given orally that is currently being studied in early-stage clinical trials (Phase 1/2) for the treatment of acute leukemia, a serious blood cancer. This drug works by blocking the interaction between two proteins called Menin and KMT2A (also known as MLL1), which are involved in the abnormal growth of cancer cells in certain types of leukemia. Researchers are testing bleximenib to find the safest and most effective dose for patients, and to determine how well it can help control or eliminate leukemia cells in people whose cancer has specific genetic changes.

Investigated diseases

Acute Leukemia – Acute leukemia is a type of cancer that affects the blood and bone marrow, where blood cells are produced. In this disease, the bone marrow produces large numbers of abnormal white blood cells that do not function properly. These abnormal cells multiply rapidly and crowd out healthy blood cells in the bone marrow and bloodstream. As the disease progresses, patients may experience symptoms such as fatigue, frequent infections, easy bruising, and bleeding due to the lack of normal blood cells. The condition develops quickly over days to weeks, which is why it is called acute. Without intervention, the abnormal cells continue to accumulate and interfere with the body's ability to produce normal blood cells needed for everyday functions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506581-31-00Protocol code75276617ALE1001Estimated enrolment144 patientsSponsorJanssen - Cilag International

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