RecruitingPhase IInterventional

Bleximenib absorption, metabolism, and excretion in participants with acute leukemia

This study is testing a new medicine called bleximenib for adults with certain types of blood cancer (acute leukaemia). This cancer happens when too many immature white blood cells build up in the body. Although there are treatments, some people don't respond well or can't handle the side effects, so new options are needed. Bleximenib works by blocking a specific interaction in cancer cells, which helps stop the cancer from growing. In this study, scientists want to see exactly how the body absorbs, breaks down, and removes bleximenib. It involves taking a special version of the medicine and then the regular version, with close monitoring for safety over a few weeks.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Janssen-Cilag International NV

Enrolment target

Start

10 Nov 2025

Estimated completion

15 Jun 2026

Medical condition: Acute leukaemia Medical condition in lay language: Blood cancer Therapeutic areas: Diseases [C] - Cancer [C04]

What is this study about?

Acute leukaemia is a type of cancer that affects your blood and bone marrow, the spongy material inside your bones where blood cells are made. With this condition, your body produces too many immature white blood cells, which can't do their job properly and can spread to other parts of the body. While there are treatments available, they don't work for everyone, or sometimes the side effects are too difficult to manage. This means there's a real need to find new and better ways to treat this serious illness.

This study is looking at a new medicine called bleximenib. This medicine is designed to specifically target certain proteins in cancer cells that are known to make acute leukaemia worse, especially in people with particular changes in their genes (like KMT2A or NPM1). By blocking these proteins, bleximenib aims to kill the cancer cells and stop the disease from progressing. The main goal of this particular study is to understand what happens to bleximenib once it's in your body – how it's absorbed, how it's changed, and how your body gets rid of it. This information is really important for future studies and for working out the best ways to use the medicine.

Although you might not personally benefit from taking part in this specific study, the information gathered will be incredibly valuable. It will help doctors and researchers understand if bleximenib could be a safe and effective treatment for more people with acute leukaemia in the future.

Key takeaways

This study evaluates bleximenib, a potential new treatment for acute leukaemia.
It focuses on understanding how the body processes the medicine.
Suitable for adults with certain types of acute leukaemia that have returned or not responded to past treatments.
Involves taking a special version of bleximenib, then the regular medicine, with close monitoring.
Participation helps future patients, though individual benefits are not guaranteed.
The study takes place in the UK and is funded by an American pharmaceutical company.

Who may be eligible?

This study is looking for adult volunteers, aged 18 or older, who have a type of blood cancer called acute leukaemia. Specifically, your leukaemia must have come back after treatment (relapsed) or not responded to previous treatments (refractory). You also need to have certain changes in your genes, such as KMT2A, NPM1, NUP98, or NUP214, which your doctors will be able to check.

Before you can join, the study team will check your general health, including your blood tests and how well your kidneys and liver are working. You'll also need to be able to move around fairly easily. All participants must agree to use effective birth control during the study and for a period afterwards because the medicine could affect fertility or a developing baby.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have acute leukaemia that has come back or not responded to previous treatments?
Has your doctor confirmed that your leukaemia has specific gene changes (like KMT2A or NPM1)?
Are your kidney and liver tests within the required limits?
Are you able to manage having regular bowel movements?
Are you willing to use effective contraception if you are a woman who could become pregnant or a man with a female partner?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve a few stages. First, there's a screening phase lasting up to 30 days, where doctors will check if you're suitable for the study. If you are, you'll move into the treatment phase, which lasts for about 28 days.

On Day 1, you'll receive a single dose of bleximenib that has a special 'radiotag' (14C-bleximenib). This special tag helps researchers track how the medicine moves through your body. The next day, and for the rest of the 28 days, you'll take the regular bleximenib medicine twice a day. During this time, you'll be monitored closely. After the treatment phase, there's a safety follow-up phase lasting up to 30 days. During this time, doctors will keep checking on your health and any side effects. The total time you'd be involved in the study would be between 28 and 58 days. Sometimes, if eligible, participants might have the option to continue taking bleximenib in another related study.

Potential risks and benefits

It's important to know that you might not personally experience any benefits from taking part in this study. However, the information learned will be very helpful for future patients with acute leukaemia. All medicines have potential risks and side effects. For bleximenib, based on how it works, some possible serious side effects could include problems with your body making blood cells, serious reactions as cancer cells break down (differentiation syndrome, tumor lysis syndrome), infections, and potential effects on your heart (shown by an irregular reading on an ECG). There could also be an impact on your fertility. You'll receive a detailed document explaining all known risks, and you can discuss these thoroughly with the study team. You are always free to withdraw from the study at any time without giving a reason.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Christie NHS Foundation Trust
City only
Manchester, England

Common questions

What is acute leukaemia?

It's a fast-growing cancer of the blood and bone marrow, where too many immature white blood cells are made.

What does bleximenib do?

It's a new medicine designed to block certain proteins in cancer cells, aiming to kill them and stop the cancer from getting worse.

Why use a 'radiotagged' drug?

A special version of bleximenib helps researchers track exactly how your body takes in, uses, and gets rid of the medicine.

How long will I be in the study?

The study itself lasts about 28 to 58 days from beginning to end, including screening and follow-up.

Can I stop participating if I want to?

Yes, you can leave the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Aakta Al-Naqdi

aalnaqdi@its.jnj.com +44 (0)7880 443 442 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.