A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025)
ConditionPolycythemia Vera
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bomedemstat
DrugOral Capsule
Ruxolitinib
DrugOral Tablet
Ropeginterferon alfa-2b
DrugSubcutaneous Solution
Treatment groups
380 Participants
are divided into 2 treatment groupsGroup A: BomedemstatExperimental treatment 1 intervention
Group B: Best Available Therapy (BAT)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Clinicohematologic Response (CHR) Rate
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.
Time frame
Up to approximately Week 52Secondary outcomes
1
Clinicohematologic Response Sustained for a 24-Week Time Period (CHR24)
CHR24 is defined as all of the following: (i) a confirmed hematologic remission sustained for at least 24 consecutive weeks by 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 MF or MDS/AML. CHR24 will begin on the date of the first confirmed assessment achieving CHR24 criteria and will end on the earliest date of the following: 1) day of the first confirmed assessment not achieving CHR24 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 CHR24 will be presented.
Time frame
Up to approximately Week 522
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience AE will be reported.
Time frame
Up to approximately Week 523
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame
Up to approximately Week 524
Duration of Clinicohematologic Response Sustained for a 24-Week Time Period (DOCHR24)
For participants who show CHR24, DOCHR24 is defined as the time from the first confirmed hematologic remission to first documented evidence of: 1) confirmed platelet increase, confirmed WBC increase, or a required phlebotomy (defined as a confirmed HCT reduction) after latest confirmed hematologic remission date, 2) thrombotic event as assessed by the adjudication committee, 3) major hemorrhagic event as assessed by the adjudication committee, or 4) disease progression to MF or MDS/AML as assessed by the adjudication committee.
Time frame
Up to approximately Week 52Sponsors and contacts
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Source ClinicalTrials.gov