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A Study of Bomedemstat for Essential Thrombocythemia

This study is looking at a new medication called bomedemstat (also known as MK-3543) for people with essential thrombocythemia (ET). ET is a condition where your body makes too many platelets, which are blood cells that help with clotting. You might be able to join if you have ET and your current treatment with hydroxyurea hasn't worked well or you couldn't tolerate it. Researchers want to see if bomedemstat is better than other common treatments like anagrelide, busulfan, interferon alfa, or ruxolitinib. The main goal is to see if bomedemstat leads to a lasting improvement in your blood counts and symptoms, called a durable clinicohematologic response, over about a year.

Study design
This study is comparing bomedemstat to other available treatments in about 340 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured for up to approximately 52 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06079879

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)

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~340 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:BomedemstatAnagrelideBusulfanInterferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2bRuxolitinib

At a glance

Recruiting sites
0 of 163 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Durable Clinicohematologic Response (DCHR) Rate
Measured over Up to approximately 52 weeks

Conditions

Essential Thrombocythemia

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NCT06079879

Where you'd take part

This study runs at 163 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Addenbrooke's Hospital ( Site 3303)

    Cambridge, Cambridgeshire, United Kingdomno site contact published

  • Affiliated Hospital of Nantong University ( Site 3527)

    Nantong, Jiangsu, Chinano site contact published

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk-Internal Medicine ( Site 2302)

    Dordrecht, South Holland, Netherlandsno site contact published

  • Anhui Provincial Hospital ( Site 3513)

    Hefei, Anhui, Chinano site contact published

  • Ankara Bilkent Şehir Hastanesi ( Site 3201)

    Ankara, Turkey (Türkiye)no site contact published

  • Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 3210)

    Ankara, Turkey (Türkiye)no site contact published

  • Antalya Egitim ve Arastırma Hastanesi ( Site 3207)

    Antalya, Turkey (Türkiye)no site contact published

  • Aotearoa Clinical Trials ( Site 0050)

    Auckland, New Zealandno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms (confirmed by a central pathologist)
Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance
Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive therapy
Has a platelet count \> 450 × 10\^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention
Has an absolute neutrophil count (ANC) ≥0.75 × 10\^9/L assessed up to 72 hours before first dose of study intervention
Participants may have received up to 3 prior ET-directed cytoreductive agents including hydroxyurea

Exclusion

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation
History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study
Evidence at the time of Screening of increased risk of bleeding
History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

What this trial measures

  • Durable Clinicohematologic Response (DCHR) RateUp to approximately 52 weeks

    DCHR rate is the percentage of participants with DCHR, defined as a confirmed reduction of platelet count to ≤400 × 10\^9/L and absence of white blood cell (WBC) count elevation to \>10 × 10\^9/L locally assessed to be due to ET, starting by Week 24 and maintained for at least 24 weeks, and the absence of any thrombotic or major hemorrhagic events or disease progression to myelofibrosis (MF), myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) by Week 52.