Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
ConditionEssential Thrombocythemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Bomedemstat
- Hydroxyurea
- Bomedemstat placebo
- Hydroxyurea placebo
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov