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NCT06351631PHASE3Recruiting

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

Merck Sharp & Dohme LLC

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

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Interventions

DRUG

Bomedemstat

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Conditions

Thrombocythemia, EssentialPrimary MyelofibrosisMyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia MyelofibrosisPolycythemia Vera

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