A Study of Bomedemstat for Blood Cancers

This study is evaluating the long-term safety and effectiveness of bomedemstat (MK-3543-017) in people with certain blood cancers like essential thrombocythemia (too many platelets), primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis. You may be able to join if you are already taking bomedemstat in a related study (IMG-7289-202/MK-3543-005), have been taking it for at least 6 months, are tolerating it well, and your doctor believes it is helping you. If you are in other studies for essential thrombocythemia or polycythemia vera, you must have achieved confirmed remission. The study aims to gather information on side effects and how well the drug works over time. The study plans to enroll 400 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive bomedemstat in oral capsule form at doses of 10, 15, 20, or 50 mg. The study plans to enroll 400 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 10 years to track adverse events and treatment discontinuation.

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NCT06351631

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~400 participants
Updated 2026-04-02 on ClinicalTrials.gov
What's tested:Bomedemstat

At a glance

Recruiting sites
18 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants with one or more adverse events (AEs)
Measured over Up to ~10 years
+1 more outcome measured
Thrombocythemia, Essential
Primary Myelofibrosis
Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
Polycythemia Vera
21 sites across 15 states
Italy3
New South Wales2
Queensland2
New Zealand2
London, City of2
Michigan1
North Carolina1
Ohio1
  • Medical Director · STUDY_DIRECTOR · Merck Sharp and Dohme LLC

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Eligibility criteria

Inclusion

Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready
Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
Is not currently on a dose hold
Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat

Exclusion

Has received prohibited concomitant medications
Ongoing or planned participation in another investigational study
Has noncompliance in prior bomedemstat study receiving \<90% of assigned doses excluding suspensions or holds as assigned by the investigator
  • Percentage of participants with one or more adverse events (AEs)Up to ~10 years

    An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants with AEs will be presented.

  • Percentage of participants who discontinued study treatment due to an AEUp to ~10 years

    An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who discontinued study treatment due to an AE will be presented.