Status:
RECRUITING
Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Essential Thrombocythemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 cytoreduct...
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
Key Trial Info
Start Date :
July 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 24 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06456346
Start Date
July 16 2024
End Date
March 24 2028
Last Update
March 13 2026
Active Locations (166)
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1
Palo Verde Cancer Specialists ( Site 0052)
Glendale, Arizona, United States, 85304
2
Los Angeles Cancer Network ( Site 0025)
Glendale, California, United States, 91206
3
Stanford Cancer Center ( Site 0024)
Palo Alto, California, United States, 94304
4
Exempla Lutheran Medical Center ( Site 0014)
Golden, Colorado, United States, 80401