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Clinical Trials in the UK / NCT06456346
Active, not recruiting Phase 3

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

NCT06456346 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2024-07-16
Last updated
2026-08-27

Condition(s) studied

Essential Thrombocythemia

Investigational drug(s) / intervention(s)

BomedemstatHydroxyureaBomedemstat placeboHydroxyurea placebo

Bomedemstat: Oral capsule

Hydroxyurea: Oral capsule

Bomedemstat placebo: Oral capsule placebo

Hydroxyurea placebo: Oral capsule placebo

Study summary

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 cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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 * 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 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

Primary outcome measure(s)

Trial sites (171)

FacilityCityRegionStatus
Palo Verde Cancer Specialists ( Site 0052) Glendale Arizona
Los Angeles Cancer Network ( Site 0025) Glendale California
Stanford Cancer Center ( Site 0024) Palo Alto California
Exempla Lutheran Medical Center ( Site 0014) Golden Colorado
Yale University School of Medicine ( Site 0051) New Haven Connecticut
Parkview Research Center at Parkview Regional Medical Center ( Site 0006) Fort Wayne Indiana
University of Michigan ( Site 0003) Ann Arbor Michigan
Optum Care Cancer Center ( Site 0053) Las Vegas Nevada
Levine Cancer Institute ( Site 0009) Charlotte North Carolina
Duke University Health System (DUHS) ( Site 0012) Durham North Carolina
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013) Winston-Salem North Carolina
The Ohio State University Wexner Medical Center ( Site 0028) Columbus Ohio
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8005) Eugene Oregon
Oregon Health & Science University ( Site 0018) Portland Oregon
TriStar Bone Marrow ( Site 7000) Nashville Tennessee
Texas Oncology - West Texas ( Site 8003) Amarillo Texas
Texas Oncology - DFW ( Site 8006) Dallas Texas
University of Texas MD Anderson Cancer Center ( Site 0026) Houston Texas
University of Texas Health Science Center at San Antonio ( Site 0021) San Antonio Texas
Texas Oncology - Gulf Coast ( Site 8008) Webster Texas
University of Virginia ( Site 0020) Charlottesville Virginia
VCU Health Adult Outpatient Pavillion ( Site 0008) Richmond Virginia
Hospital Universitario Austral ( Site 0101) Pilar Buenos Aires
Hospital Italiano de Buenos Aires ( Site 0102) ABB Buenos Aires F.D.
C.I.C.E. 9 de Julio ( Site 0104) San Miguel de Tucumán Tucumán Province
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0105) Santa Fe Argentina
Westmead Hospital ( Site 0201) Westmead New South Wales
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0203) Adelaide South Australia
Monash Health-Haematology Research ( Site 0202) Clayton Victoria
Austin Health-Cancer Clinical Trials Centre ( Site 0206) Heidelberg Victoria
Royal Perth Hospital-Haematology ( Site 0204) Perth Western Australia
Ordensklinikum Linz GmbH Elisabethinen ( Site 0562) Linz Upper Austria
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0038) Calgary Alberta
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0037) Greenfield Park Quebec
Biocenter ( Site 0149) Concepción Biobio
IC La Serena Research ( Site 0150) La Serena Coquimbo Region
FALP-UIDO ( Site 0148) Santiago Region M. de Santiago
Clínica Inmunocel ( Site 0147) Santiago Region M. de Santiago
Clínica Alemana de Santiago ( Site 0143) Santiago Region M. de Santiago
Bradfordhill-Clinical Area ( Site 0142) Santiago Region M. de Santiago

+ 131 more sites — see the full list on the official registry below.

More Merck Sharp & Dohme LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06456346 on ClinicalTrials.gov ↗ ← All trials in the UK