RecruitingPHASE3INTERVENTIONAL

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

This research study, called MK-3543-007, is looking at a new drug called Bomedemstat to treat Essential Thrombocythemia (ET). ET is a condition where your body makes too many blood platelets. This study aims to see if Bomedemstat is more effective and safer than Hydroxyurea, which is a common treatment for ET. They are particularly interested in people who haven't had treatment for their ET before and for whom treatment is recommended. The main goal is to find out if Bomedemstat can lead to a lasting positive response in managing the condition, better than Hydroxyurea. This could potentially offer a new treatment option for those living with ET.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

300

Start

16 Jul 2024

Estimated completion

24 Mar 2028

Essential Thrombocythemia

What is this study about?

This study is for people diagnosed with Essential Thrombocythemia (ET). ET is a rare, long-term condition where your body produces too many platelets, which are tiny blood cells that help stop bleeding. Having too many platelets can lead to problems like blood clots or bleeding. Some people with ET need treatment to lower their platelet count and reduce these risks.

The purpose of this study is to compare a new medicine called Bomedemstat with a long-standing treatment called Hydroxyurea. Hydroxyurea is a common drug used to reduce the number of platelets in people with ET. Researchers want to see if Bomedemstat works better and is just as safe, or safer, than Hydroxyurea. They are specifically focusing on people who are newly diagnosed with ET and haven't had treatment for it before, but for whom treatment is now recommended by their doctor.

The main thing the study wants to find out is if Bomedemstat can lead to a more stable and lasting improvement in your blood counts and overall condition compared to Hydroxyurea. If Bomedemstat proves to be more effective, it could become a new and important treatment option for people with ET in the future.

Key takeaways

This study compares a new drug (Bomedemstat) with a standard treatment (Hydroxyurea) for ET.
It's for people newly diagnosed with ET who need treatment.
The main goal is to see if Bomedemstat offers a better, lasting response.
Participation involves taking medication and regular health check-ups.
You'll be closely monitored by medical professionals.
You can stop participating at any time.

Who may be eligible?

To join this study, you must have been diagnosed with Essential Thrombocythemia (ET) according to specific medical guidelines, and your doctor must recommend that you start treatment for it, regardless of your age or risk. Your bone marrow, which is where blood cells are made, must show only a mild level of scarring (Grade 0 or 1). It's also important that you haven't received any treatment for your ET in the past.

If you have HIV, it needs to be well-controlled with medication. If you have Hepatitis B, you should have been on antiviral treatment for at least a month, and the virus should not be detectable in your blood. For those with a history of Hepatitis C, the virus must also be undetectable.

However, you won't be able to join if you have certain other conditions. This includes any serious stomach or gut problems that might stop your body from absorbing medicines properly. Also, if you've had cancer in the past two years, unless it was fully cured. People with active infections needing strong medication, or those who have recently had major surgery (within the last 4 weeks or still recovering), also cannot take part. Additionally, if you have HIV and a history of specific related conditions called Kaposi's sarcoma or Multicentric Castleman's Disease, you cannot participate.

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.

I have been diagnosed with Essential Thrombocythemia (ET).
My doctor has suggested I start treatment for my ET.
I have never been treated for my ET before.
I do not have any severe stomach or gut problems.
I haven't had cancer in the last two years (unless fully cured earlier).

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you will be assigned to receive either Bomedemstat or Hydroxyurea, or a dummy version (placebo) of one of these, though the main comparison is between the active drugs. Throughout the study, you will have regular visits to the clinic for medical check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. This will involve physical examinations, discussions about your symptoms, and possibly additional tests like bone marrow biopsies at certain points. You will be given the study medication to take as instructed. The total length of your participation, including the treatment period and follow-up, will be explained in detail by the study team, but clinical trials usually involve ongoing monitoring for a significant period.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring throughout the study. However, there are also potential risks; the new medication might cause side effects, which could be mild or serious, and it may not work better than existing treatments. We don't yet know the full effects of Bomedemstat. You will be fully informed about all known risks and side effects before you decide to join. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (170)

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

Palo Verde Cancer Specialists ( Site 0052)
Verified postcode
Glendale, United States· Recruiting
Los Angeles Cancer Network ( Site 0025)
Verified postcode
Glendale, United States· Recruiting
Stanford Cancer Center ( Site 0024)
Verified postcode
Palo Alto, United States· Recruiting
Exempla Lutheran Medical Center ( Site 0014)
Verified postcode
Golden, United States· Recruiting
Yale University School of Medicine ( Site 0051)
Verified postcode
New Haven, United States· Recruiting
Parkview Research Center at Parkview Regional Medical Center ( Site 0006)
Verified postcode
Fort Wayne, United States· Completed
University of Michigan ( Site 0003)
Verified postcode
Ann Arbor, United States· Recruiting
Optum Care Cancer Center ( Site 0053)
Verified postcode
Las Vegas, United States· Recruiting
Levine Cancer Institute ( Site 0009)
Verified postcode
Charlotte, United States· Recruiting
Duke University Health System (DUHS) ( Site 0012)
Verified postcode
Durham, United States· Recruiting
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013)
Verified postcode
Winston-Salem, United States· Recruiting
The Ohio State University Wexner Medical Center ( Site 0028)
Verified postcode
Columbus, United States· Recruiting

Common questions

What is Essential Thrombocythemia (ET)?

ET is a condition where your body makes too many blood platelets, which are important for blood clotting. Too many platelets can lead to health problems.

What is Bomedemstat?

Bomedemstat is a new medicine being tested in this study to see if it can help control the high platelet count in people with ET.

What is Hydroxyurea?

Hydroxyurea is a standard medication already used to treat ET by helping to lower the number of platelets in the blood.

Will I know which treatment I'm receiving?

In some parts of the study, you might receive a placebo (dummy drug) or you might not know if you're getting Bomedemstat or Hydroxyurea. This is to ensure fair results.

How long will the study last for me?

The exact duration of your involvement will be discussed with you by the study team, as it can vary depending on the trial's design and your individual response.

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.