Actively Recruiting
A Phase 3, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Bomedemstat Versus Hydroxyurea in Cytoreductive Therapy Naffve Essential Thrombocythemia
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
300
Participants Needed
171
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of bomedemstat compared with hydroxyurea in adults diagnosed with essential thrombocythemia ET who have not previously received cytoreductive therapy but require it. The main goal is to see if bomedemstat can provide a better durable clinicohematologic response DCHR than hydroxyurea. This Phase 3, randomized, double-blind trial aims to improve treatment options for people with ET by comparing these two therapies. Participants will be randomly assigned to receive either active bomedemstat with a placebo for hydroxyurea or active hydroxyurea with a placebo for bomedemstat. Both treatments are given as oral capsules daily for up to 52 weeks, with doses adjusted to safely reduce platelet counts within a target range. After completing the initial treatment period, eligible participants may continue treatment in an extended phase. Placebos will be stopped and unblinding will occur once all participants finish or discontinue the 52-week therapy. During the study, participants will have regular assessments to monitor blood counts, symptom changes using specific fatigue and symptom questionnaires, and the occurrence of thrombotic or hemorrhagic events. Researchers will evaluate durable hematologic remission and disease progression up to Week 52. Safety will be closely followed through adverse event tracking. The total study participation includes the initial 52-week treatment and possible extension, with detailed monitoring throughout to assess treatment effects and safety.
CONDITIONS
Brief Title
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization criteria
- Indication for cytoreductive therapy regardless of age or risk status
- Bone marrow fibrosis score of Grade 0 or Grade 1 as assessed centrally
- No prior cytoreductive treatment for ET
- Well-controlled HIV infection on antiretroviral therapy
- Hepatitis B surface antigen positive participants eligible if on antiviral therapy for at least 4 weeks with undetectable viral load
- Participants with history of Hepatitis C virus infection eligible if viral load is undetectable
You will not qualify if you...
- History of gastrointestinal illness or impairment that might interfere with drug absorption
- History of any malignancy unless potentially curative treatment completed with no evidence of cancer for 2 years
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Active infection requiring systemic therapy
- Major surgery within 4 weeks prior to first dose or not recovered from side effects of major surgery done more than 4 weeks before first dose
Research Team
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