Not yet recruitingPhase IIInterventional

A study testing two targeted medicines, bomedemstat, which helps normalise blood cell development, and momelotinib, which reduces symptoms and anaemia, to see whether the combination is safe and effective for people with myelofibrosis

This study is testing a new approach for people with a blood condition called myelofibrosis. It combines two medicines: bomedemstat, which aims to help blood cells develop normally, and momelotinib, which can reduce symptoms and improve anaemia. The researchers want to find out if taking these two medicines together is safe and works better than momelotinib on its own. This trial focuses on patients already taking momelotinib who haven't improved enough, or those who have low blood counts from the start and don't get better after 12 weeks of momelotinib. It's a Phase II study, meaning it's still in the early stages of testing, looking at safety and how well the treatment works.

At a glance

Status

Not yet recruiting

Phase

Phase II

Sponsor

United Lincolnshire Hospitals NHS Trust

Enrolment target

Start

01 Nov 2026

Estimated completion

01 Nov 2028

Myelofibrosis

What is this study about?

Myelofibrosis is a condition where scar tissue builds up in the bone marrow, affecting how the body makes healthy blood cells. This can lead to symptoms like tiredness, anaemia (low red blood cells), and a swollen spleen. Medicines such as momelotinib are used to help manage these symptoms and improve blood counts for some people.

However, for some individuals, momelotinib alone might not be enough, or they might have low blood counts when they start treatment that don't get much better. This study explores whether adding another medicine, bomedemstat, to momelotinib could offer a more effective treatment. Bomedemstat is thought to help balance blood cell development, so the idea is that by combining it with momelotinib, which targets symptoms and anaemia, patients might see greater benefits.

This trial is an early-stage study (Phase II) meaning that we are still learning about this specific combination. Researchers are keen to see if this treatment is safe and if it can improve how patients feel and how their blood counts look. The study is particularly looking at patients who haven't had the best response to momelotinib by itself or those who start with very low blood counts.

Key takeaways

This study tests two medicines, bomedemstat and momelotinib, for myelofibrosis.
It aims to see if combining them is safer and more effective than momelotinib alone.
It's for adults (18+) with myelofibrosis who haven't responded well to momelotinib or have low blood counts.
Participation involves different stages, including taking momelotinib alone, then combined with bomedemstat.
The study is taking place at United Lincolnshire Hospitals NHS Trust.
It's a Phase II study, meaning it's an early-stage trial.

Who may be eligible?

To join this study, you must be 18 years or older and have been diagnosed with myelofibrosis. This includes primary myelofibrosis, or myelofibrosis that developed after polycythaemia vera or essential thrombocythaemia. Your condition must also be classed as intermediate-2 or high-risk.

There are two main groups of people this study is looking for. The first group includes those who have already been taking momelotinib (200mg once a day) for at least 12 weeks and haven't seen enough improvement. The second group includes those with low levels of red blood cells (anaemia) or platelets (cells that help blood clot) when they start the study, who then begin momelotinib and don't improve enough after 12 weeks.

There are some reasons why you might not be able to take part. For example, if you are allergic to either of the study drugs or have certain serious stomach or bleeding problems. You also can't be taking certain other medicines or have had some specific prior treatments, like other drugs from the same family as bomedemstat. The research team will carefully check all your medical information to see if this study is right for you.

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 a diagnosis of myelofibrosis?
Has your myelofibrosis been classified as intermediate-2 or high-risk?
Are you currently taking momelotinib and it's not working well enough, OR do you have low blood counts and would start momelotinib in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several phases. First, there's a 'screening' phase which lasts up to 28 days to check if you're suitable. Then, everyone will start by taking momelotinib on its own for the first 12 weeks. Following this, if you meet certain criteria, you will move into a phase where you take both momelotinib and bomedemstat together for another 12 weeks (up to Week 24).

Throughout the study, you will continue taking momelotinib unless your doctors decide it's not safe or causing too many side effects. After your treatment phase ends, there will be a follow-up period for 30 days after your last dose of medication. There will also be a longer-term follow-up to track your health and survival over time. The study will involve regular visits and assessments to monitor your health, blood counts, and any side effects.

Potential risks and benefits

The specific benefits and risks of taking part in this study were not fully available at the time of its registration. In general, potential benefits of participating in a clinical trial can include close monitoring of your health by a medical team and access to new treatments before they are widely available. However, there's no guarantee that the treatment will be effective for you. Potential risks might include side effects from the medications, which could be mild or more serious, and the inconvenience of extra hospital visits or assessments. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

United Lincolnshire Teaching Hospitals NHS Trust
City only
Lincoln, England

Common questions

What is myelofibrosis?

Myelofibrosis is a condition where scar tissue builds up in your bone marrow, affecting your body's ability to make healthy blood cells.

What kind of study is this?

It's a Phase II interventional study, meaning it's an early-stage trial testing a specific combination of medicines for safety and how well they work.

Who is funding this research?

The study is funded by a pharmaceutical company called MSD Sharp and Dohme GmbH.

How long will the study run?

The study is expected to run from November 2026 to November 2029.

Will I have to pay to be part of the study?

No, you don't have to pay to participate in clinical trials. All study-related care and medication are provided.

How to find out more

Ciro Rinaldi

crinaldi@nhs.net +44 07720373877 Official trial record

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