Merck-006: Bomedemstat vs BAT for Essential Thrombocythemia - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Essential Thrombocythemia

Who Can Participate in the Study?

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

For more information about who can join this study, please contact the study team at terri.lucas@duke.edu or 919-681-6580.

Age Group
Adults

What is Involved?

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

If you are eligible to join, you will proceed to the study drug period. During this period, you will get a random assignment (like a coin flip) to 1 of 2 groups:

  • Group 1 will take the study drug
  • Group 2 will take a comparison drug (anagrelide, busulfan, interferon alfa, or ruxolitinib)

You will take the study drug or comparison drug by mouth each day for up to one year. You will visit our clinic every other week during the first 12 weeks you take the study or comparison drug, and then visit our clinic once per month after the first 12 weeks have passed

If you finish a one-year course of the study drug regimen, you will have the option to extend your participation in the study. We will let you know at this time if you were in Group 1 or Group 2. If you were in Group 1, you can continue to take the study drug. If you were in Group 2, you will have the option to switch over to the study drug or to continue to take the same drug you were assigned. This study extension will last for up to 2 years. You will visit our clinic every 4 weeks if you choose to participate in the extension.

At various visits during the study, you will complete physical exams, have blood draws, have ECGs, answer questionnaires, have swabs taken from your cheek, and have bone marrow samples taken.

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
Hematologic Oncologist
Protocol Number
IRB: PRO00114762
NCT: NCT06079879
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment