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RECRUITINGPhase 3NCT06456346

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

The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreduct...

Lead sponsor: Merck Sharp & Dohme LLC•17 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

Sponsors

Lead Sponsor

Merck Sharp & Dohme LLC

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

Exclusion Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 20, 2026Terms

Trial snapshot

StatusRECRUITING

PhasePHASE3

Enrollment300

Start dateJul 2024

Last updatedMar 20, 2026

Condition

Essential Thrombocythemia

Locations shown

Palo Verde Cancer Specialists ( Site 0052)

Glendale, Arizona

Los Angeles Cancer Network ( Site 0025)

Glendale, California

Stanford Cancer Center ( Site 0024)

Palo Alto, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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