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Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06456346.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Approved
Name Not Available
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not Available
North Carolina
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Status: Active
Name Not Available
Durham
Duke University Medical Center
Status: Active
Name Not Available
Ohio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Approved
Name Not Available
Oregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
