RecruitingPHASE1INTERVENTIONAL

A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

This study is investigating a new drug, bleximenib, for people in the UK with acute leukaemia, which is a fast-growing blood cancer. The main goal is to understand how your body takes in, processes, and gets rid of bleximenib. For this, a special version of the drug will be used that can be easily tracked inside the body. This is a very early-stage study (Phase 1), which means it's one of the first times this drug is being tested in humans. The study aims to gather important information about how the drug works in the body.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Janssen Research & Development, LLC

Enrolment target

Start

18 Nov 2025

Estimated completion

13 Jul 2026

Acute Lymphoblastic Leukemia Acute Leukemias Acute Myeloid Leukemia

What is this study about?

This research study is about a new drug called bleximenib, which is being investigated as a potential treatment for acute leukaemia. Acute leukaemia is a serious and fast-developing cancer of the blood and bone marrow. In this condition, the body produces too many immature white blood cells, which don't work properly.

The main purpose of this study is to understand what happens to bleximenib once it's in your body. This includes how much of the drug your body absorbs, how it breaks the drug down, and how it eventually gets rid of it. To do this, researchers will use a specially marked version of bleximenib. This marking helps them track the drug's journey through your body.

By understanding how bleximenib moves through the body, researchers can learn more about how strong a dose might be needed and how often it should be given. This information is crucial for developing potential new treatments for acute leukaemia effectively and safely in the future.

Key takeaways

Tests a new drug called bleximenib for acute leukaemia.
Aims to understand how the body processes the drug.
Uses a specially marked version of the drug for tracking.
This is an early-stage (Phase 1) study.
Participants must have specific types of acute leukaemia that have returned or not responded to other treatments.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and weigh 40 kilograms (about 6 stone 4 pounds) or more.

The study is for people with acute leukaemia that has either returned (relapsed) or hasn't responded to previous treatments (refractory). This specific type of leukaemia needs to have certain changes in its genes (KMT2A, NPM1, NUP98, or NUP214 mutations). You also need to have tried all available treatments or not be suitable for them, and generally be well enough to take part.

Some conditions would prevent you from joining. These include certain types of leukaemia (like acute promyelocytic leukaemia), cancer that has spread to the brain or spinal cord, or if you've had an organ transplant. You also can't have had major surgery recently or have significant side effects from previous cancer treatments that haven't improved.

Quick self-check

Am I 18 years old or older?
Do I weigh at least 40 kilograms?
Do I have acute leukaemia that has returned or not responded to other treatments, specifically with certain gene changes?
Have I tried or am I not suitable for other available leukaemia treatments?
Am I generally well enough to take part and have regular bowel movements?
Have I not had major surgery recently and am I not planning one?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will receive the study drug, bleximenib, which has been specially marked to help researchers track its path through your body. You'll have regular hospital visits for check-ups, blood tests, and other assessments. These appointments are designed to monitor your health, see how the drug is affecting you, and track its movement in your body. The study team will explain the full schedule of visits and tests during your initial discussions. The total duration of your participation in the study, including follow-up, will be clearly outlined by the medical team.

Potential risks and benefits

Participating in research studies like this can have potential benefits, as it offers access to a new drug that isn't widely available. While this is an early-stage study, the information gathered is vital for future research and could contribute to better treatments for acute leukaemia. However, like all medications, bleximenib may have side effects, and not everyone will respond to the treatment. The research team will carefully monitor you for any potential risks or side effects throughout your participation. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom· Recruiting

Common questions

What is acute leukaemia?

Acute leukaemia is a type of cancer that affects the blood and bone marrow. It causes the body to make too many unhealthy white blood cells.

What does a 'radiolabeled' drug mean?

It means the drug has a tiny, safe amount of a special marker attached. This marker helps doctors track the drug's journey in your body using special scans.

What does Phase 1 study mean?

Phase 1 is the first stage of testing a new drug in humans. It focuses on how the drug works in the body and if it's safe, rather than how effective it is yet.

Will I get better if I join this study?

This study is mainly to understand the drug. While there's a chance it might help, the main purpose isn't to treat your cancer but to learn about the drug's behavior in the body.

Can women who are pregnant take part?

No, women who are pregnant or could become pregnant would not be able to join this study due to safety reasons.

How to find out more

Study Contact

Participate-In-This-Study1@its.jnj.com 844-434-4210 Official trial record

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