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Bomedemstat extension trial tests Long-Term safety for blood cancer patients

NCT ID NCT05223920

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at the long-term safety of bomedemstat, an oral drug, in 81 people with myeloproliferative neoplasms (MPNs) like essential thrombocythemia and primary myelofibrosis. Participants had already taken bomedemstat in a prior study. Researchers tracked side effects, spleen size, and platelet counts to see if the drug remains safe and effective over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bomedemstat (oral capsule)
What this could lead to
If successful, this study could show that bomedemstat is safe and effective for long-term control of myeloproliferative neoplasms, offering a new treatment option.
What could go wrong
This is a small, early-phase extension study with no placebo group, so results may not prove long-term benefit. Side effects are possible, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

81 people

The number who actually took part.

Started

Dec 2021

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion Criteria include, but are not limited to: * Has completed at least one Treatment Period (TP) in a prior bomedemstat Myeloproliferative Neoplasms (MPN) protocol (such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003) (NCT04254978). * In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat. Exclusion Criteria: Exclusion Criteria include, but are not limited to: * Ongoing participation in another investigational study (except observational studies). * A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted). * Current use of a prohibited medication (e.g., romiplostim). * Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol. * Is pregnant or breastfeeding or plan to become pregnant or breastfeed during the study. * Women of childbearing potential (WOCBP) and fertile men unwilling to agree to use an approved method of contraception from time of enrollment until 14 days after last bomedemstat dose.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Azienda Ospedaliera SS. Antonio

    Alessandria, 15121, Italy

  • Azienda Ospedaliero Universitaria di Bologna

    Pavia, 27100, Italy

  • Azienda Ospedaliero-Universitaria Careggi - S.O.D. Ematologia (CRIMM)

    Florence, 50134, Italy

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Gold Coast Hospital and Health Service

    Southport, Queensland, 4215, Australia

  • Guy's and Saint Thomas' NHS Foundation Trus

    London, SE1 9RT, United Kingdom

  • Middlemore Clinical Trials

    Papatoetoe, Aukland, 2025, New Zealand

  • Ospedale di Circolo-a Fondazione Macchi

    Varese, VA, 2100, Italy

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • UMPC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Universittsklinikum Essen

    Essen, 45147, Germany

  • University College London Hospitals NHS Foundation Trust

    London, NW1 12G, United Kingdom

  • University of Miami Leonard M. Miller

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Waitemata District Health Board

    Takapuna, Aukland, 0622, New Zealand

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