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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Essential Thrombocythemia

In brief

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.

Key facts

Study ID

NCT06456346

Run by

Merck Sharp & Dohme LLC

People needed

300

Starts

2024-07-16

Expected to finish

2028-03-24

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Los Angeles Cancer Network ( Site 0025) — Glendale, California, United States
• Stanford Cancer Center ( Site 0024) — Palo Alto, California, United States
• Exempla Lutheran Medical Center ( Site 0014) — Golden, Colorado, United States
• Yale University School of Medicine ( Site 0051) — New Haven, Connecticut, United States
• Parkview Research Center at Parkview Regional Medical Center ( Site 0006) — Fort Wayne, Indiana, United States
• University of Michigan ( Site 0003) — Ann Arbor, Michigan, United States
• Optum Care Cancer Center ( Site 0053) — Las Vegas, Nevada, United States
• Levine Cancer Institute ( Site 0009) — Charlotte, North Carolina, United States
• Duke University Health System (DUHS) ( Site 0012) — Durham, North Carolina, United States
• Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 0013) — Winston-Salem, North Carolina, United States
• The Ohio State University Wexner Medical Center ( Site 0028) — Columbus, Ohio, United States
• Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8005) — Eugene, Oregon, United States
• Oregon Health & Science University ( Site 0018) — Portland, Oregon, United States
• TriStar Bone Marrow ( Site 7000) — Nashville, Tennessee, United States
• Texas Oncology - West Texas ( Site 8003) — Amarillo, Texas, United States
• Texas Oncology - DFW ( Site 8006) — Dallas, Texas, United States
• University of Texas MD Anderson Cancer Center ( Site 0026) — Houston, Texas, United States
• University of Texas Health Science Center at San Antonio ( Site 0021) — San Antonio, Texas, United States
• Texas Oncology - Gulf Coast ( Site 8008) — Webster, Texas, United States
• University of Virginia ( Site 0020) — Charlottesville, Virginia, United States
• VCU Health Adult Outpatient Pavillion ( Site 0008) — Richmond, Virginia, United States
• Hospital Universitario Austral ( Site 0101) — Pilar, Buenos Aires, Argentina
• Hospital Italiano de Buenos Aires ( Site 0102) — ABB, Buenos Aires F.D., Argentina
• C.I.C.E. 9 de Julio ( Site 0104) — San Miguel de Tucumán, Tucumán Province, Argentina
• Palo Verde Cancer Specialists ( Site 0052) — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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