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

RecruitingPhase 3Ages 18 Years - anyAllMerck Sharp & Dohme LLC
NCT06351631 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Bomedemstat
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Where

21 sites
University of Michigan ( Site 6000)
Ann Arbor, United States
DUHS Duke Blood Cancer Center ( Site 6005)
Durham, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
Columbus, United States
UPMC Hillman Cancer Center ( Site 6004)
Pittsburgh, United States
Royal Prince Alfred Hospital ( Site 1003)
Camperdown, Australia
Royal North Shore Hospital ( Site 1001)
St Leonards, Australia
Sunshine Coast Hematology and Oncology Clinic ( Site 1006)
Buderim, Australia
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)
Southport, Australia

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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