Evaluating the safety and effectiveness of bomedemstat for blood disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to transition participants who have been safely tolerating bomedemstat into an extension phase to gather long-term safety and efficacy data. Participants must have received at least six months of treatment with bomedemstat and show clinical benefit as assessed by the investigator. The study focuses on individuals with essential thrombocythemia and myelofibrosis who have achieved confirmed hematologic remission. No hypothesis testing will be conducted, emphasizing observational data collection.

Why it matters

Who can join: the full rules

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 response, 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

Where it's running

• University of Michigan ( Site 6000)
  Ann Arbor, Michigan, United States Recruiting
• DUHS Duke Blood Cancer Center ( Site 6005)
  Durham, North Carolina, United States Recruiting
• The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
  Columbus, Ohio, United States Recruiting
• UPMC Hillman Cancer Center ( Site 6004)
  Pittsburgh, Pennsylvania, United States Recruiting
• Royal Prince Alfred Hospital ( Site 1003)
  Camperdown, New South Wales, Australia Recruiting
• Royal North Shore Hospital ( Site 1001)
  St Leonards, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.