RecruitingPhase 3NCT06351631

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

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


Sponsor

Merck Sharp & Dohme LLC

Enrollment

400 participants

Start Date

May 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bomedemstat for people with myelofibrosis, polycythemia vera, and other related conditions. The study is currently recruiting participants at 21 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBomedemstat

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06351631


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