RecruitingPHASE3INTERVENTIONAL

A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)

This study is testing a new medicine called bomedemstat for a blood condition known as essential thrombocythemia, or ET. ET causes your body to make too many platelets, which are tiny cells that help blood clot. The study is for people who have ET and whose usual medicine, hydroxyurea, isn't helping enough or is causing difficult side effects. We want to find out if bomedemstat is more effective and safer than other available treatments like Anagrelide, Busulfan, Interferon alfa, or Ruxolitinib. By comparing these treatments, the researchers hope to offer better options for managing this condition. The main goal is to see if bomedemstat can lead to a lasting improvement in symptoms and blood counts.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

340

Start

31 Dec 2023

Estimated completion

18 Aug 2028

Essential Thrombocythemia

What is this study about?

This study is about a blood condition called essential thrombocythemia, often shortened to ET. In ET, your body produces too many small blood cells called platelets. While platelets are important for stopping bleeding, having too many can sometimes lead to serious problems like blood clots or, less commonly, bleeding issues. Many people with ET take a medicine called hydroxyurea to help control their platelet levels.

However, for some people, hydroxyurea either stops working well or causes side effects that are difficult to manage. This study is for those individuals. Researchers want to compare a new medicine, bomedemstat, with other established treatments already used for ET, such as Anagrelide, Busulfan, Interferon alfa, or Ruxolitinib. They want to find out if bomedemstat is a better option for people whose previous treatment isn't quite right.

The main aim is to see if bomedemstat can provide a more lasting and effective control of platelet counts and other symptoms of ET, compared to what is currently available. This is a "Phase 3" study, which means it's one of the final steps in testing a new medicine before it can potentially be made widely available. It's a large study designed to confirm the safety and benefits of bomedemstat.

Key takeaways

Tests a new medicine (bomedemstat) for essential thrombocythemia (ET).
For ET patients whose current treatment (hydroxyurea) isn't working or causing problems.
Compares bomedemstat to other standard ET treatments.
Aims to find a more lasting and effective way to manage ET.
Requires regular hospital visits and monitoring.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or over and have been diagnosed with essential thrombocythemia (ET) by an expert. You would also need to have received hydroxyurea for your ET in the past, but it either didn't work well enough, or you couldn't tolerate its side effects.

Your bone marrow, which is where blood cells are made, should show only minor changes related to ET. Your platelet count must also be above 450 (x 10^9/L) just before starting the study medicine. You also need to have a certain level of white blood cells (specifically, neutrophils) of at least 0.75 (x 10^9/L).

There are also some reasons why you might not be able to join. For example, if you've had a bad allergic reaction to medicines similar to bomedemstat or to any of the other treatments being compared. If you have stomach or gut problems that might stop the medicine from being absorbed properly, or if you have a high risk of bleeding, you might not be eligible. If you've had certain types of cancer in the last two years, this might also prevent you from joining, though some very common and easily treated skin cancers (like basal cell carcinoma) wouldn't stop 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 essential thrombocythemia (ET)?
Has hydroxyurea stopped working well for your ET, or did you have bad side effects from it?
Is your platelet count currently high (above 450)?
Do you have good general health, without severe gut issues or high bleeding risk?

Answer every question to see your result.

What does participation involve?

If you join this study, you’ll receive either the new medicine, bomedemstat, or one of the existing best available treatments for ET. Your treatment will be decided by chance, like flipping a coin. You'll have regular hospital visits for check-ups, blood tests, and to discuss any side effects you might be experiencing. These visits will help the doctors monitor your health and how the treatment is working. The study is designed to measure how safe and effective the treatments are over time. The exact number and frequency of visits, as well as the total length of your participation, will be explained in detail by the study team. You'll be given all the study medication as part of your participation.

Potential risks and benefits

Participating in this study might offer you access to a new treatment, bomedemstat, before it's widely available, which could potentially improve your ET symptoms or blood counts. However, there's no guarantee it will work for you, and like all medicines, bomedemstat and the other treatments have potential side effects. These will be fully explained by the study team. You might also experience side effects from the other treatments if you are assigned to one of those arms. There could be risks associated with the tests and procedures involved in the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (163)

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

Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496)
Verified postcode
Glendale, United States· Recruiting
Los Angeles Cancer Network ( Site 3491)
Verified postcode
Glendale, United States· Recruiting
Stanford Cancer Institute ( Site 0107)
Verified postcode
Stanford, United States· Recruiting
The Lundquist Institute ( Site 3423)
Verified postcode
Torrance, United States· Recruiting
University of Colorado Anschutz Medical Campus ( Site 3425)
Verified postcode
Aurora, United States· Recruiting
Tufts Medical Center ( Site 3408)
Verified postcode
Boston, United States· Recruiting
University of Michigan ( Site 0008)
Verified postcode
Ann Arbor, United States· Recruiting
Henry Ford Hospital ( Site 3413)
Verified postcode
Detroit, United States· Recruiting
Optum Care Cancer Center ( Site 3497)
Verified postcode
Las Vegas, United States· Recruiting
Roswell Park Cancer Institute ( Site 3421)
Verified postcode
Buffalo, United States· Recruiting
Duke University Health System (DUHS) ( Site 0016)
Verified postcode
Durham, United States· Recruiting
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400)
Verified postcode
Winston-Salem, United States· Recruiting

Common questions

What is essential thrombocythemia (ET)?

ET is a condition where your body makes too many platelets, which are blood cells that help with clotting. This can sometimes lead to blood clots or bleeding issues.

What is bomedemstat?

Bomedemstat is a new medicine being tested in this study for people with ET who haven't responded well to standard treatments or experienced side effects.

Will I definitely receive bomedemstat if I join?

Not necessarily. Participants will be randomly assigned to receive either bomedemstat or one of the established treatments currently used for ET.

What kind of commitment is joining the study?

You'll have regular hospital visits for check-ups, blood tests, and to get your study medication. The study team will explain the full schedule.

Can I leave the study if I change my mind?

Yes, you have the right to leave the study at any time, for any reason, and it won't affect your ongoing medical care.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

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