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
Merck Sharp & Dohme LLC
Summary
This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (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 therapy with respect to durable clinicohematologic response (DCHR).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms (confirmed by a central pathologist) * Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis * Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance * Has an inadequate or loss of response to their most recent prior ET therapy, requiring a change of cytoreductive thera…
Interventions
- DrugBomedemstat
Oral Capsule
- DrugAnagrelide
Oral Capsule
- DrugBusulfan
Oral Tablet
- DrugInterferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b
Subcutaneous Solution
- DrugRuxolitinib
Oral Tablet
Locations (163)
- Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496)Glendale, Arizona
- Los Angeles Cancer Network ( Site 3491)Glendale, California
- Stanford Cancer Institute ( Site 0107)Stanford, California
- The Lundquist Institute ( Site 3423)Torrance, California
- University of Colorado Anschutz Medical Campus ( Site 3425)Aurora, Colorado
- Tufts Medical Center ( Site 3408)Boston, Massachusetts