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NCT06456346

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

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~300 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:BomedemstatHydroxyureaBomedemstat placeboHydroxyurea placebo

At a glance

Recruiting sites
0 of 171 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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Essential Thrombocythemia

NCT06456346

Where you'd take part

This study runs at 171 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0324)

    Aarhus, Central Jutland, Denmarkno site contact published

  • Akademiska sjukhuset ( Site 0545)

    Uppsala, Uppsala County, Swedenno site contact published

  • Anhui Provincial Hospital ( Site 0657)

    Hefei, Anhui, Chinano site contact published

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0502)

    Ankara, Turkey (Türkiye)no site contact published

  • Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 0511)

    Ankara, Turkey (Türkiye)no site contact published

  • Antalya Egitim ve Arastırma Hastanesi ( Site 0508)

    Antalya, Turkey (Türkiye)no site contact published

  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 0038)

    Calgary, Alberta, Canadano site contact published

  • Austin Health-Cancer Clinical Trials Centre ( Site 0206)

    Heidelberg, Victoria, Australiano 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

Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status
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 received no prior cytoreductive treatment for their ET
Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion

History of any illness/impairment of gastrointestinal function that might interfere with drug absorption
History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has an active infection requiring systemic therapy
Has had a major surgery \<4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery \>4 weeks prior to first dose

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, 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.