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Study on the Safety of Bomedemstat for Patients with Myeloproliferative Neoplasms Who Participated in a Previous Bomedemstat Study

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a group of diseases known as myeloproliferative neoplasms, which include essential thrombocythemia, polycythemia vera, and myelofibrosis. These are conditions where the bone marrow makes too many blood cells. The treatment being tested in this study is a medication called bomedemstat, also known by its code name MK-3543. This medication is taken orally in the form of a hard capsule.

The purpose of the study is to evaluate the safety and tolerability of bomedemstat. Participants in this study have previously been involved in a bomedemstat clinical trial and have been receiving the medication for at least six months. The study will continue to monitor these participants to ensure the treatment remains safe and to observe any potential side effects. Participants will take the medication at home and will be required to swallow the capsules as directed.

Throughout the study, researchers will keep track of any adverse events, which are unwanted effects that may occur during treatment. They will also monitor whether participants need to stop the treatment due to these effects. For those with essential thrombocythemia or polycythemia vera, the study will look at how long the treatment continues to work effectively. Additionally, the study will observe if there is any progression to more serious conditions like myelodysplastic syndrome or acute myeloid leukemia. The study aims to provide valuable information on the long-term use of bomedemstat for these conditions.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after completing a previous study involving bomedemstat.
Eligibility requires at least 6 months of prior treatment with bomedemstat and a positive response to the medication.
Step 2
Medication administration
Bomedemstat is administered in the form of a hard capsule.
The medication is taken orally, following specific instructions for at-home dosing.
Step 3
Monitoring and evaluation
The study aims to evaluate the safety and tolerability of bomedemstat.
Participants are monitored for any adverse events, which are side effects or reactions to the medication.
Step 4
Study duration
The study is an extension of previous research and is expected to continue until February 5, 2035.
Participants will be involved in the study as long as they continue to benefit from the treatment and do not experience significant adverse events.

Who can join the trial?

7 criteria

The patient must have been part of a previous study involving a medication called **bomedemstat** and be ready for a new study identified as MK-3543-017.
The patient should have been treated with **bomedemstat** for at least 6 months in a specific study (IMG-7289-202/MK-3543-005), and they must have tolerated the medication well and benefited from it according to the doctor's assessment.
If the patient was part of other studies, they must have achieved a confirmed **hematologic remission** (meaning their blood condition has improved), tolerated **bomedemstat** safely, and benefited from it according to the doctor's assessment.
The patient must be able to start the study treatment on the first day of the extension study, meaning they are not currently on a break from the medication.
The patient must be able to swallow pills and follow instructions for taking **bomedemstat** at home.
Both male and female patients are eligible to participate.
The study does not include vulnerable populations, meaning it is not designed for groups that might need special protection.

Who cannot join the trial?

10 criteria

Patients with other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with a history of allergic reactions to similar medications.
Patients who are unable to follow the study procedures or instructions.
Patients with certain types of infections that could affect the study results.
Patients who have had a recent surgery or are planning to have surgery soon.
Patients with a history of drug or alcohol abuse.
Patients who are taking medications that might interfere with the study drug.
Patients with certain heart conditions that could pose a risk during the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Alexandria, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Verified
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Varese, Italy

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Investigated drugs

Bomedemstat is a medication being studied for its safety and effectiveness in treating participants who were part of a previous clinical study involving this drug. The main goal of this trial is to ensure that bomedemstat is safe for use and to understand how well it is tolerated by patients.

Bomedemstat

What is already known about the treatment

Bomedemstat – Bomedemstat is administered orally in the form of tablets. It is currently being studied in clinical trials, specifically for its safety and efficacy in treating myeloproliferative neoplasms, including essential thrombocythemia, polycythemia vera, and myelofibrosis. The medication works by inhibiting an enzyme called LSD1, which plays a role in the regulation of blood cell production. Bomedemstat is classified as an enzyme inhibitor, and its development is focused on providing a new treatment option for these blood disorders.

Investigated diseases

Essential Thrombocythemia
This is a blood disorder characterized by the overproduction of platelets by the bone marrow. It often progresses slowly and may not cause symptoms initially. Over time, it can lead to complications such as blood clots or bleeding. Patients may experience headaches, dizziness, or vision changes. The condition is often discovered during routine blood tests.
Polycythemia Vera
This is a type of blood cancer that results in the overproduction of red blood cells. It can cause the blood to thicken, leading to slower blood flow and potential clotting issues. Symptoms may include fatigue, itching, and a ruddy complexion. As the disease progresses, it can lead to complications such as an enlarged spleen or blood clots. It is often diagnosed through blood tests showing elevated red blood cell counts.
Myelofibrosis
This is a serious bone marrow disorder that disrupts the body's normal production of blood cells. It leads to extensive scarring in the bone marrow, resulting in severe anemia and an enlarged spleen. Patients may experience fatigue, weakness, and abdominal discomfort. The disease can progress to more severe forms of blood cancer. It is often identified through blood tests and bone marrow examination.