Bomedemstat extension trial tests Long-Term safety for blood cancer patients
NCT ID NCT05223920
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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81 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Aug 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Azienda Ospedaliera SS. Antonio
Alessandria, 15121, Italy
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Azienda Ospedaliero Universitaria di Bologna
Pavia, 27100, Italy
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Azienda Ospedaliero-Universitaria Careggi - S.O.D. Ematologia (CRIMM)
Florence, 50134, Italy
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
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Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
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Gold Coast Hospital and Health Service
Southport, Queensland, 4215, Australia
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Guy's and Saint Thomas' NHS Foundation Trus
London, SE1 9RT, United Kingdom
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Middlemore Clinical Trials
Papatoetoe, Aukland, 2025, New Zealand
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Ospedale di Circolo-a Fondazione Macchi
Varese, VA, 2100, Italy
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Queen Mary Hospital
Hong Kong, Hong Kong
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Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
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Royal North Shore Hospital
Saint Leonards, New South Wales, 2065, Australia
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Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
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UMPC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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Universittsklinikum Essen
Essen, 45147, Germany
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University College London Hospitals NHS Foundation Trust
London, NW1 12G, United Kingdom
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University of Miami Leonard M. Miller
Miami, Florida, 33136, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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Waitemata District Health Board
Takapuna, Aukland, 0622, New Zealand
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