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Sponsor: Merck Sharp & Dohme LLC
Conditions: Essential Thrombocythemia
Interventions: Bomedemstat, Hydroxyurea, Bomedemstat placebo, Hydroxyurea placebo
Countries: United States, Argentina, Australia, Austria, Canada, Chile, China, Colombia
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Glendale, Arizona, United States
- Glendale, California, United States
- Palo Alto, California, United States
- Golden, Colorado, United States
- New Haven, Connecticut, United States
- Fort Wayne, Indiana, United States
- Ann Arbor, Michigan, United States
- Las Vegas, Nevada, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Columbus, Ohio, United States
- Eugene, Oregon, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Amarillo, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Webster, Texas, United States
- Charlottesville, Virginia, United States
- Richmond, Virginia, United States
- Pilar, Buenos Aires, Argentina
- ABB, Buenos Aires F.D., Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- Santa Fe, Argentina
- Westmead, New South Wales, Australia
- Adelaide, South Australia, Australia
- Clayton, Victoria, Australia
- Heidelberg, Victoria, Australia
- + 141 more on CT.gov