This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available treatment (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available treatment with respect to durable clinicohematologic response (DCHR).
A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)
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, MK-3543-006
All genders
18+
Recruiting now
Overview
Principal Investigator: Zheng (Frank) Zhou, MD
Contact Us
Latoya Marshall
Study details
Inclusion Criteria
- 1. Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms
- 2. Has a bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis
- 3. Has a history of inadequate response to or intolerance of hydroxyurea per at least 1 of the following criteria, based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance: hydroxyurea resistance (or inadequate response) or hydroxyurea Intolerance
Exclusion Criteria
- 1. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) that contraindicates participation
- 2. History of any illness/impairment of GI function that might interfere with drug absorption (eg, chronic diarrhea or history of gastric bypass surgical procedure), confound the study results or pose an additional risk to the individual by participation in the study
- 3. Evidence at the time of Screening of increased risk of bleeding