RecruitingPHASE2INTERVENTIONAL

Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis

This study is testing a new treatment plan for a type of bone marrow disorder called myelofibrosis. People with myelofibrosis often have anaemia and need regular blood transfusions. The study is investigating a combination of two medicines, momelotinib and luspatercept, to see if they can help reduce the need for these transfusions. Patients will be included whether they have recently been diagnosed or have had myelofibrosis for a while, and whether they have had previous treatments for it or not. The main goal is to find out if this new combination treatment is safe and works well for people who are dependent on transfusions, meaning they need them often to manage their condition.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

Start

28 Feb 2025

Estimated completion

17 Mar 2028

Primary Myelofibrosis Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis

What is this study about?

Myelofibrosis is a rare but serious condition that affects the bone marrow, which is the spongy tissue inside your bones where blood cells are made. In myelofibrosis, the bone marrow becomes scarred, making it difficult for the body to produce enough healthy blood cells. This can lead to a shortage of red blood cells, a condition called anaemia, which often causes extreme tiredness, weakness, and can make everyday tasks difficult.

Many patients with myelofibrosis, particularly those with more advanced disease, need regular blood transfusions to help manage their anaemia and improve their quality of life. Current treatments aim to control symptoms, but finding ways to reduce the need for transfusions is very important for patients' well-being. This study is exploring a new approach by combining two existing drugs, momelotinib and luspatercept, to see if they can work together more effectively.

Momelotinib is a type of drug that targets specific pathways in the body involved in myelofibrosis. Luspatercept helps in the making of red blood cells. By combining them, researchers hope to improve how well patients' bodies produce their own red blood cells, potentially reducing or even eliminating the need for transfusions. This research is important because it could offer a new and better treatment option for people living with myelofibrosis who struggle with transfusion dependence.

Key takeaways

This study investigates a new combination treatment for myelofibrosis.
It aims to reduce the need for blood transfusions in patients.
It's open to those new to treatment or who have had previous drugs.
The treatment involves taking tablets and having injections.
Participation includes regular clinic visits and health checks.
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of myelofibrosis. This includes primary myelofibrosis, or myelofibrosis that developed after having other blood conditions like polycythemia vera or essential thrombocythemia. You also need to be someone who regularly receives blood transfusions because of your myelofibrosis – typically, this means you've needed at least four units of blood in the two months before the study starts, and your haemoglobin levels were low even before the transfusions.

This study is open to people who haven't had previous treatments for myelofibrosis, as well as those who have been treated with certain other medications like ruxolitinib or fedratinib for a period of time. However, there are some reasons why you might not be able to join. For example, if you have certain bowel conditions that could affect how your body absorbs the study drugs, or if you've had certain types of cancer within the last five years, you wouldn't be able to take part. Also, if your anaemia is due to other specific causes like an iron deficiency or an active, uncontrolled infection, you might not be eligible.

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 or older?
Do you have a confirmed diagnosis of myelofibrosis?
Do you regularly receive blood transfusions for your myelofibrosis?
Have you discussed any existing bowel conditions with your doctor?
Are you free from recent other serious cancers?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive two medications: momelotinib (a tablet you take by mouth) and luspatercept (given as an injection). The study team will explain exactly how to take these. You will have regular visits to the clinic, which will include physical examinations, blood tests, and possibly other tests to see how you are responding to the treatment and to check for any side effects. The study involves a screening period to make sure you are eligible, then the main treatment period, and finally a follow-up period after you stop taking the study drugs. The total time you'll be involved in the study will depend on your individual response and how long the researchers decide to continue giving the treatment, but it will involve multiple appointments over several months.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that the combination of momelotinib and luspatercept might help reduce your need for blood transfusions and improve your myelofibrosis symptoms. However, like all medications, these drugs can have side effects, which the study team will discuss with you in detail. There is also no guarantee that the treatment will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (33)

GSK Investigational Site
Verified postcode
Ann Arbor, United States· Recruiting
GSK Investigational Site
Verified postcode
New York, United States· Recruiting
GSK Investigational Site
Verified postcode
Nashville, United States· Recruiting
GSK Investigational Site
Verified postcode
Houston, United States· Recruiting
GSK Investigational Site
Verified postcode
Seattle, United States· Recruiting
GSK Investigational Site
Verified postcode
Vancouver, Canada· Recruiting
GSK Investigational Site
Verified postcode
Toronto, Canada· Recruiting
GSK Investigational Site
Verified postcode
Montreal, Canada· Recruiting
GSK Investigational Site
Verified postcode
Montreal, Canada· Recruiting
GSK Investigational Site
Verified postcode
Angers, France· Recruiting
GSK Investigational Site
Verified postcode
Brest, France· Recruiting
GSK Investigational Site
Verified postcode
Lyon, France· Recruiting

Common questions

What is myelofibrosis?

Myelofibrosis is a condition where scar tissue forms in your bone marrow, affecting its ability to make healthy blood cells, especially red blood cells.

Why is this study focused on blood transfusions?

Many people with myelofibrosis need regular blood transfusions due to anaemia. This study hopes to find a treatment that reduces or stops this need.

What are momelotinib and luspatercept?

These are two medicines that work in different ways to help manage myelofibrosis symptoms and red blood cell production.

Will I have to pay to be in the study?

No, all study-related treatments and tests will be provided at no cost to you.

What if I feel unwell during the study?

You will have regular contact with the study team, and you should always tell them about any new or worsening symptoms you experience.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

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