A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
Recruiting now · Phase 3
Conditions studied: Thrombocythemia, Essential, Primary Myelofibrosis, Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera
In brief
The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: * Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; * Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission. No hypothesis testing will be conducted in this study.
Key facts
- Study ID
- NCT06351631
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 400
- Starts
- 2024-05-23
- Expected to finish
- 2034-12-04
- Last updated by the study team
- 2026-04-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Michigan ( Site 6000) — Ann Arbor, Michigan, United States (enrolling)
- DUHS Duke Blood Cancer Center ( Site 6005) — Durham, North Carolina, United States (enrolling)
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007) — Columbus, Ohio, United States (enrolling)
- UPMC Hillman Cancer Center ( Site 6004) — Pittsburgh, Pennsylvania, United States (enrolling)
- Royal Prince Alfred Hospital ( Site 1003) — Camperdown, New South Wales, Australia (enrolling)
- Royal North Shore Hospital ( Site 1001) — St Leonards, New South Wales, Australia (enrolling)
- Sunshine Coast Hematology and Oncology Clinic ( Site 1006) — Buderim, Queensland, Australia (enrolling)
- Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002) — Southport, Queensland, Australia (enrolling)
- Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000) — Adelaide, South Australia, Australia (enrolling)
- Monash Health ( Site 1004) — Clayton, Victoria, Australia (enrolling)
- Boston Pilgrim Hospital ( Site 3403) — Boston, Lincolnshire, United Kingdom (enrolling)
- University College London Hospital ( Site 3400) — London, London, City of, United Kingdom (enrolling)
- Guy's & St Thomas' NHS Foundation Trust ( Site 3401) — London, London, City of, United Kingdom (enrolling)
- Azienda Ospedaliera Universitaria Careggi ( Site 2700) — Florence, Tuscany, Italy (enrolling)
- Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703) — Alessandria, Italy (enrolling)
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702) — Bologna, Italy (enrolling)
- Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701) — Varese, Italy (enrolling)
- Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402) — London, Hammersmith and Fulham, United Kingdom (enrolling)
- Queen Mary Hospital ( Site 1601) — Hksar, Hong Kong
- North Shore Hospital-Department of Haematology ( Site 1401) — Auckland, New Zealand
- Aotearoa Clinical Trials ( Site 1400) — Auckland, New Zealand
Full record on ClinicalTrials.gov
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