Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called bomedemstat (the study drug) for people with essential thrombocythemia who are unable to take hydroxyurea or do not get a benefit from it.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with essential thrombocythemia
- Have a documented intolerance or inadequate response to hydroxyurea
- Are not at an increased risk of having bleeding events
What is Involved?
Description
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have an ECG
- Have blood draws
- Have a tumor biopsy
- Group 1 will take the study drug
- Group 2 will take a comparison drug (anagrelide, busulfan, interferon alfa, or ruxolitinib)
Study Details
Full Title
A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543/IMG-7289) versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia who have an Inadequate Response to or are Intolerant of Hydroxyurea
Principal Investigator
Lindsay
Rein
Protocol Number
PRO00114762
NCT ID
NCT06079879
Phase
III
Enrollment Status
Open to Enrollment