A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
Start Date
5/23/2024
Completion Date
12/4/2034
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Bomedemstat
Conditions
Locations
University of Michigan ( Site 6000)
Ann Arbor, Michigan 48109
United States
DUHS Duke Blood Cancer Center ( Site 6005)
Durham, North Carolina 27705
United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
Columbus, Ohio 43210
United States
UPMC Hillman Cancer Center ( Site 6004)
Pittsburgh, Pennsylvania 15232
United States
Royal Prince Alfred Hospital ( Site 1003)
Camperdown, New South Wales 2050
Australia
Royal North Shore Hospital ( Site 1001)
St Leonards, New South Wales 2065
Australia
Sunshine Coast Hematology and Oncology Clinic ( Site 1006)
Buderim, Queensland 4556
Australia
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)
Southport, Queensland 4215
Australia
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)
Adelaide, South Australia 5000
Australia
Monash Health ( Site 1004)
Clayton, Victoria 3168
Australia
Queen Mary Hospital ( Site 1601)
Hksar,
Hong Kong
Azienda Ospedaliera Universitaria Careggi ( Site 2700)
Florence, Tuscany 50134
Italy
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)
Alessandria, 15121
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)
Bologna, 40138
Italy
Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)
Varese, 21100
Italy
North Shore Hospital-Department of Haematology ( Site 1401)
Auckland, 0622
New Zealand
Aotearoa Clinical Trials ( Site 1400)
Auckland, 2025
New Zealand
Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)
London, Hammersmith and Fulham W12 0HS
United Kingdom
Boston Pilgrim Hospital ( Site 3403)
Boston, Lincolnshire PE21 9QS
United Kingdom
University College London Hospital ( Site 3400)
London, London, City of NW1 2PG
United Kingdom
Guy's & St Thomas' NHS Foundation Trust ( Site 3401)
London, London, City of SE1 9RT
United Kingdom