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)
Running, not enrolling · Phase 3
Conditions studied: Essential Thrombocythemia
In brief
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).
Key facts
- Study ID
- NCT06079879
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 340
- Starts
- 2023-12-31
- Expected to finish
- 2028-08-18
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 therapy
- Has a platelet count > 450 × 10\^9/L (450k /μL) assessed up to 72 hours before first dose of study intervention
- Has an absolute neutrophil count (ANC) ≥0.75 × 10\^9/L assessed up to 72 hours before first dose of study intervention
- Participants may have received up to 3 prior ET-directed cytoreductive agents including hydroxyurea
You may not qualify if…
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to bomedemstat or lysine demethylase or monoamine oxidase inhibitor (LSDi or MAOi) or the chosen best available therapy (including anagrelide, interferon alfa/pegylated interferon, ruxolitinib, or busulfan) that contraindicates participation
- 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
- Evidence at the time of Screening of increased risk of bleeding
- History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
- Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Where it is running
- Los Angeles Cancer Network ( Site 3491) — Glendale, California, United States
- Stanford Cancer Institute ( Site 0107) — Stanford, California, United States
- The Lundquist Institute ( Site 3423) — Torrance, California, United States
- University of Colorado Anschutz Medical Campus ( Site 3425) — Aurora, Colorado, United States
- Tufts Medical Center ( Site 3408) — Boston, Massachusetts, United States
- University of Michigan ( Site 0008) — Ann Arbor, Michigan, United States
- Henry Ford Hospital ( Site 3413) — Detroit, Michigan, United States
- Optum Care Cancer Center ( Site 3497) — Las Vegas, Nevada, United States
- Roswell Park Cancer Institute ( Site 3421) — Buffalo, New York, United States
- Duke University Health System (DUHS) ( Site 0016) — Durham, North Carolina, United States
- Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400) — Winston-Salem, North Carolina, United States
- Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000) — Eugene, Oregon, United States
- Medical University of South Carolina-Hollings Cancer Center ( Site 3426) — Charleston, South Carolina, United States
- University of Virginia ( Site 3422) — Charlottesville, Virginia, United States
- VCU Health Adult Outpatient Pavillion ( Site 3416) — Richmond, Virginia, United States
- Hospital Universitario Austral ( Site 0104) — Pilar, Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires ( Site 0105) — ABB, Buenos Aires F.D., Argentina
- C.I.C.E. 9 de Julio ( Site 1001) — San Miguel de Tucumán, Tucumán Province, Argentina
- Royal Prince Alfred Hospital ( Site 1100) — Camperdown, New South Wales, Australia
- Liverpool Hospital-Haematology ( Site 0501) — Liverpool, New South Wales, Australia
- Royal North Shore Hospital ( Site 0003) — St Leonards, New South Wales, Australia
- Calvary Mater Newcastle ( Site 0505) — Waratah, New South Wales, Australia
- Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0001) — Adelaide, South Australia, Australia
- Monash Health-Haematology Research ( Site 0006) — Clayton, Victoria, Australia
- Palo Verde Hematology/ Oncology Center, Ltd. ( Site 3496) — Glendale, Arizona, United States
Full record on ClinicalTrials.gov
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