A Study of Bomedemstat (MK-3543) in Participants With Polycythemia Vera (MK-3543-004)

Launched by IMAGO BIOSCIENCES, INC., A SUBSIDIARY OF MERCK & CO., INC., (RAHWAY, NEW JERSEY USA) · Sep 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called bomedemstat, which is taken by mouth, for people with a condition called polycythemia vera (PV). PV is a type of blood disorder where the body makes too many red blood cells. The trial aims to understand how safe and effective bomedemstat is, as well as how it works in the body. Participants who show improvement and can handle the medication well may continue treatment for up to a year.

To join the trial, participants must have a confirmed diagnosis of polycythemia vera and have already tried at least one standard treatment that didn’t work for them. They also need to have a certain level of bone marrow health and be able to live for at least 36 weeks. However, individuals with serious health issues or certain infections, as well as those who are pregnant or nursing, cannot participate. Throughout the study, participants will be monitored closely, and their health will be assessed to see if the treatment is helping. This trial is currently active, but not recruiting new participants at this time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Has a diagnosis of Polycythemia Vera per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms
• • Has a bone marrow fibrosis score of Grade 0 or Grade 1
• • Has failed at least one standard cytoreductive therapy to lower hematocrit
• • Has a life expectancy \>36 weeks
• • Has discontinued prior cytoreductive therapy for 2 weeks (4 weeks for interferon) prior to study drug initiation
• Exclusion Criteria:
• • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater
• • Has unresolved treatment related toxicities from prior therapies (unless resolved to ≤ Grade 1)
• • Has an uncontrolled active infection
• • Has a known human immunodeficiency virus (HIV) infection or active Hepatitis B or Hepatitis C virus infection
• • Has evidence of increased risk of bleeding, including known bleeding disorders
• • Is pregnant or lactating