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 study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Awyiwhc Oewjnrmbaxd Nqclrdqpi Sl Anvtjhb E Bhhuca E C Aqyrdg Adsjqswprju	Alexandria	Italy
Aipnkiu Uyblt Sracukiza Ljjsed Dw Bzegvgx	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	03.06.2024

Trial locations

Investigated drugs:

Bomedemstat

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.

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.

Trial ID:

2023-506996-89-00

Protocol code:

MK-3543-017

NCT ID:

NCT06351631

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?