RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

This study is designed for individuals who are currently being treated with a medication called bomedemstat for specific blood conditions, such as essential thrombocythemia, polycythemia vera, or myelofibrosis. The main goal is to allow these participants to continue receiving bomedemstat in a new study. This new phase will help researchers collect more long-term information on how safe the medicine is and how well it continues to work. It focuses on people who have already shown good responses to bomedemstat and are tolerating it well. This study is not testing a new treatment, but rather extending the observation of an existing one for current patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

400

Start

23 May 2024

Estimated completion

04 Dec 2034

Thrombocythemia, Essential Primary Myelofibrosis Myelofibrosis Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis Polycythemia Vera

What is this study about?

This study, called "MK-3543-017", is looking at a medicine named bomedemstat. It's for people who have certain blood conditions like essential thrombocythemia, polycythemia vera, or myelofibrosis and are already taking bomedemstat (or have been in a recent study for it).

The main aim of this study is to allow people who are already doing well on bomedemstat to keep taking it. By continuing to follow these patients, doctors can gather more information over a longer period about the medicine's safety and how well it keeps working. This is important to understand the long-term effects of bomedemstat.

Think of this study like a continuation. It’s not trying out a brand new treatment or comparing bomedemstat to another medicine. Instead, it’s giving people who are already benefiting from bomedemstat the chance to carry on with their treatment while providing valuable long-term data to researchers.

Key takeaways

This study is for continuing treatment with bomedemstat if you're already taking it.
It helps doctors gather long-term safety and effectiveness information.
You must already be doing well on bomedemstat to join.
You will continue to take bomedemstat by mouth and have regular check-ups.
It's about ongoing observation, not testing a new treatment.

Who may be eligible?

To join this study, you must already be taking bomedemstat as part of an earlier study sponsored by Imago BioSciences or MSD. Your doctor must believe you are safely tolerating the medicine and that it's helping you.

If you were in the IMG-7289-202/MK-3543-005 study, you need to have received bomedemstat for at least six months. If you have essential thrombocythemia (ET) or polycythemia vera (PV) and were in a different study, your blood counts needed to have improved and stayed steady (this is called 'hematologic remission').

You also need to be able to swallow medication, follow instructions for taking it at home, and not be taking certain other medicines that could interfere with bomedemstat. You shouldn't be participating in another medical study or have previously shown that you didn't take your bomedemstat doses as prescribed.

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 currently taking bomedemstat from a previous study?
Does your doctor think bomedemstat is currently helping you?
Have you been safely tolerating bomedemstat?
Can you swallow tablets and manage taking medicine at home?
Are you at least 18 years old?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to take bomedemstat as prescribed by your doctor. This medicine is taken by mouth. You will have regular appointments with your study doctor and nurses. During these visits, they will check on your health, ask about any side effects, and take blood samples to see how you are responding to the treatment. The main purpose is to monitor your health and the effects of bomedemstat over a longer time, and there won't be any new experimental procedures. The total duration involves continuing your current treatment plan under careful observation.

Potential risks and benefits

The potential benefit of joining this study is that you can continue to receive bomedemstat, a treatment that your doctor believes is already helping you. This allows for ongoing management of your condition. While bomedemstat has been studied, like all medicines, there can be potential side effects or risks, which your doctor will discuss with you. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (21)

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

University of Michigan ( Site 6000)
Verified postcode
Ann Arbor, United States· Recruiting
DUHS Duke Blood Cancer Center ( Site 6005)
Verified postcode
Durham, United States· Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
Verified postcode
Columbus, United States· Recruiting
UPMC Hillman Cancer Center ( Site 6004)
Verified postcode
Pittsburgh, United States· Recruiting
Royal Prince Alfred Hospital ( Site 1003)
Verified postcode
Camperdown, Australia· Recruiting
Royal North Shore Hospital ( Site 1001)
Verified postcode
St Leonards, Australia· Recruiting
Sunshine Coast Hematology and Oncology Clinic ( Site 1006)
Verified postcode
Buderim, Australia· Recruiting
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)
Verified postcode
Southport, Australia· Recruiting
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)
Verified postcode
Adelaide, Australia· Recruiting
Monash Health ( Site 1004)
Verified postcode
Clayton, Australia· Recruiting
Queen Mary Hospital ( Site 1601)
Unverified
Hksar, Hong Kong· Active not recruiting
Azienda Ospedaliera Universitaria Careggi ( Site 2700)
Verified postcode
Florence, Italy· Recruiting

Common questions

What is bomedemstat?

Bomedemstat is a medication studied for certain blood conditions like essential thrombocythemia, polycythemia vera, and myelofibrosis.

Is this study testing a new medicine?

No, this study is for people who are already taking bomedemstat and benefiting from it. It allows them to continue treatment while gathering more long-term information.

What are 'essential thrombocythemia' and 'polycythemia vera'?

These are types of blood conditions where your body makes too many blood cells or platelets.

How long will I be in the study?

The study aims to collect long-term information, so you would continue treatment as long as it's safe and beneficial, and the study is ongoing.

Can I stop taking part in the study if I change my mind?

Yes, you have the right to withdraw from the study at any time without giving a reason, and it won't affect your 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.