Actively Recruiting
A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for Participants From Prior Bomedemstat Clinical Studies
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-02
400
Participants Needed
21
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect long-term safety and efficacy data for participants who have been using bomedemstat and are benefiting from it, or have achieved blood count remission in certain conditions. The study includes individuals with essential thrombocythemia (ET), polycythemia vera (PV), and myelofibrosis (MF) who have previously been in earlier bomedemstat trials. It does not involve hypothesis testing but focuses on extended monitoring. Participants will take oral bomedemstat capsules once daily for up to 10 years. The dose they start with will be the same as they used in their previous study before transitioning into this extension. This allows continuous assessment of the effects and safety of the medication over a long period. During the study, participants will be closely monitored for adverse events and any reasons for stopping treatment due to side effects. For those with ET or PV, the duration of their clinical response and remission will be tracked, as well as any progression to more severe conditions. Other outcomes include the frequency of blood clots and bleeding events. Participant involvement may last up to about 10 years, with regular assessments and safety checks throughout.
CONDITIONS
Brief Title
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have been part of a bomedemstat study sponsored by Imago BioSciences, Inc. or Merck Sharp & Dohme LLC
- Must have received at least 6 months of bomedemstat treatment in the IMG-7289-202/MK-3543-005 study while tolerating it safely and benefiting clinically
- ET and PV participants from other feeder studies must have achieved confirmed hematologic remission and be safely tolerating bomedemstat with clinical benefit
- Must not currently be on a dose hold
- Must be able to swallow oral medication and follow home dosing instructions
You will not qualify if you...
- Use of prohibited medications during the study
- Participation in another investigational study ongoing or planned
- Noncompliance in prior bomedemstat study with less than 90% of assigned doses taken, excluding suspensions or holds assigned by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 10 years
Participants receive oral capsules of bomedemstat once daily at their starting dose from the feeder study to evaluate safety and efficacy.
Regular visits throughout treatment as per study schedule
Trial Site Locations
Total: 21 locations
1
University of Michigan ( Site 6000)
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
DUHS Duke Blood Cancer Center ( Site 6005)
Durham, North Carolina, United States, 27705
Actively Recruiting
3
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
Columbus, Ohio, United States, 43210
Actively Recruiting
4
UPMC Hillman Cancer Center ( Site 6004)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
5
Royal Prince Alfred Hospital ( Site 1003)
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
6
Royal North Shore Hospital ( Site 1001)
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
7
Sunshine Coast Hematology and Oncology Clinic ( Site 1006)
Buderim, Queensland, Australia, 4556
Actively Recruiting
8
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)
Southport, Queensland, Australia, 4215
Actively Recruiting
9
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)
Adelaide, South Australia, Australia, 5000
Actively Recruiting
10
Monash Health ( Site 1004)
Clayton, Victoria, Australia, 3168
Actively Recruiting
11
Queen Mary Hospital ( Site 1601)
Hksar, Hong Kong
Active, Not Recruiting
12
Azienda Ospedaliera Universitaria Careggi ( Site 2700)
Florence, Tuscany, Italy, 50134
Actively Recruiting
13
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)
Alessandria, Italy, 15121
Actively Recruiting
14
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)
Bologna, Italy, 40138
Actively Recruiting
15
Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)
Varese, Italy, 21100
Actively Recruiting
16
North Shore Hospital-Department of Haematology ( Site 1401)
Auckland, New Zealand, 0622
Active, Not Recruiting
17
Aotearoa Clinical Trials ( Site 1400)
Auckland, New Zealand, 2025
Active, Not Recruiting
18
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)
London, Hammersmith and Fulham, United Kingdom, W12 0HS
Actively Recruiting
19
Boston Pilgrim Hospital ( Site 3403)
Boston, Lincolnshire, United Kingdom, PE21 9QS
Actively Recruiting
20
University College London Hospital ( Site 3400)
London, London, City of, United Kingdom, NW1 2PG
Actively Recruiting
21
Guy's & St Thomas' NHS Foundation Trust ( Site 3401)
London, London, City of, United Kingdom, SE1 9RT
Actively Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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