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A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2024-05-23
Completion Date
2034-12-04
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Bomedemstat
10, 15, 20, and 50 mg oral capsules
Locations (21)
University of Michigan ( Site 6000)
Ann Arbor, Michigan, United States
DUHS Duke Blood Cancer Center ( Site 6005)
Durham, North Carolina, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
Columbus, Ohio, United States
UPMC Hillman Cancer Center ( Site 6004)
Pittsburgh, Pennsylvania, United States
Royal Prince Alfred Hospital ( Site 1003)
Camperdown, New South Wales, Australia
Royal North Shore Hospital ( Site 1001)
St Leonards, New South Wales, Australia
Sunshine Coast Hematology and Oncology Clinic ( Site 1006)
Buderim, Queensland, Australia
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)
Southport, Queensland, Australia
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)
Adelaide, South Australia, Australia
Monash Health ( Site 1004)
Clayton, Victoria, Australia
Queen Mary Hospital ( Site 1601)
Hksar, Hong Kong
Azienda Ospedaliera Universitaria Careggi ( Site 2700)
Florence, Tuscany, Italy
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)
Alessandria, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)
Bologna, Italy
Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)
Varese, Italy
North Shore Hospital-Department of Haematology ( Site 1401)
Auckland, New Zealand
Aotearoa Clinical Trials ( Site 1400)
Auckland, New Zealand
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)
London, Hammersmith and Fulham, United Kingdom
Boston Pilgrim Hospital ( Site 3403)
Boston, Lincolnshire, United Kingdom
University College London Hospital ( Site 3400)
London, London, City of, United Kingdom
Guy's & St Thomas' NHS Foundation Trust ( Site 3401)
London, London, City of, United Kingdom