Researchers are looking for new ways to treat polycythemia vera (PV). People with PV may receive treatment to lower the number of red blood cells in the blood, but the usual treatments may not work for everyone. Researchers want to learn if a trial medicine called bomedemstat, also called MK-3543, can treat PV. In this study, researchers will compare bomedemstat to 2 usual treatments for PV.
The goal of this study is to learn if more participants who take bomedemstat reach healthy blood cell counts and avoid major health problems from PV, compared to those who receive a usual treatment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has confirmed local diagnosis of polycythemia vera (PV) per World Health Organization (WHO) diagnostic criteria for PV
* Must have discontinued prior cytoreductive therapy for condition under study for protocol specified duration
* Has failed at least one prior line of cytoreductive therapy to lower hematocrit
* Has a history of inadequate response, resistance to, or intolerant to hydroxyurea (HU) per protocol specified criteria
* Has no evidence of splenomegaly and no symptoms attributable to splenomegaly, including early satiety, left upper quadrant discomfort, or splenic pain
* Has locally assessed bone marrow (BM) fibrosis score of Grade 0 or Grade 1 as per modified version of the European Consensus Criteria for Grading Myelofibrosis
* Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy (ART)
* 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
* Participants must be able to swallow oral medication and follow instructions for at home dosing of bomedemstat
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has history of any illness/impairment of gastrointestinal (GI) function that might interfere with drug absorption
* Has evidence at the time of screening of increased risk of bleeding
* Has history of 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
* Is currently receiving anticancer therapy
* Has an active infection requiring systemic therapy
* Has had major surgical procedure ≤4 weeks before first dose of study intervention or has not recovered from side effects of major surgical procedure
Primary outcome measure(s)
Clinicohematologic Response (CHR) Rate — Up to approximately Week 52 CHR Rate is defined as all of the following: (i) a confirmed hematologic remission sustained for at least 12 consecutive weeks by Week 40 through Week 52, (ii) and absence of any of the following as assessed by the adjudication committee Week 52: thrombotic event; major hemorrhagic events; disease progression to myelofibrosis (MF) or myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML). CHR will begin on the date of the first confirmed assessment achieving CHR criteria and will end on the earliest date of the following: 1) day of the first confirmed assessment not achieving CHR criteria, 2) date of first major hemorrhagic event or thrombotic event as assessed by the adjudication committee, or 3) disease progression as assessed by the adjudication committee. The CHR rate will be presented.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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