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Clinical Trials in the UK / NCT06079879
Active, not recruiting Phase 3

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)

NCT06079879 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2023-12-31
Last updated
2026-08-13

Condition(s) studied

Essential Thrombocythemia

Investigational drug(s) / intervention(s)

BomedemstatAnagrelideBusulfanInterferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2bRuxolitinib

Bomedemstat: Oral Capsule

Anagrelide: Oral Capsule

Busulfan: Oral Tablet

Interferon alfa/pegylated interferon alfa 2a/pegylated interferon alfa 2b: Subcutaneous Solution

Ruxolitinib: Oral Tablet

Study 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

Sex
ALL
Min age
18 Years
Max age
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 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (163)

FacilityCityRegionStatus
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
University of Michigan ( Site 0008) Ann Arbor Michigan
Henry Ford Hospital ( Site 3413) Detroit Michigan
Optum Care Cancer Center ( Site 3497) Las Vegas Nevada
Roswell Park Cancer Institute ( Site 3421) Buffalo New York
Duke University Health System (DUHS) ( Site 0016) Durham North Carolina
Wake Forest Baptist Health-Internal Medicine, Section on Hematology & Oncology ( Site 3400) Winston-Salem North Carolina
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000) Eugene Oregon
Medical University of South Carolina-Hollings Cancer Center ( Site 3426) Charleston South Carolina
University of Virginia ( Site 3422) Charlottesville Virginia
VCU Health Adult Outpatient Pavillion ( Site 3416) Richmond Virginia
Hospital Universitario Austral ( Site 0104) Pilar Buenos Aires
Hospital Italiano de Buenos Aires ( Site 0105) ABB Buenos Aires F.D.
C.I.C.E. 9 de Julio ( Site 1001) San Miguel de Tucumán Tucumán Province
Royal Prince Alfred Hospital ( Site 1100) Camperdown New South Wales
Liverpool Hospital-Haematology ( Site 0501) Liverpool New South Wales
Royal North Shore Hospital ( Site 0003) St Leonards New South Wales
Calvary Mater Newcastle ( Site 0505) Waratah New South Wales
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 0001) Adelaide South Australia
Monash Health-Haematology Research ( Site 0006) Clayton Victoria
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0502) Melbourne Victoria
Royal Perth Hospital-Haematology ( Site 0504) Perth Western Australia
ZAS Cadix ( Site 1200) Antwerp Belgium
University Of Alberta Hospital ( Site 1504) Edmonton Alberta
The Moncton Hospital-Oncology ( Site 1500) Moncton New Brunswick
The First Afflilated Hospital of Bengbu Medical College ( Site 3509) Bengbu Anhui
Anhui Provincial Hospital ( Site 3513) Hefei Anhui
Peking University Third Hospital-Hematology ( Site 3502) Beijing Beijing Municipality
Peking Union Medical College Hospital ( Site 3531) Beijing Beijing Municipality
The Second Affiliated Hospital Of Fujian Medical University ( Site 3525) Quanzhou Fujian
The First Affiliated hospital of Xiamen University ( Site 3515) Xiamen Fujian
Sun Yat-sen Memorial Hospital of Sun Yat-sen University ( Site 3524) Guangzhou Guangdong
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 3511) Guangzhou Guangdong
The First Hospital of Hebei Medical University ( Site 3510) Shijiazhuang Hebei
Henan Cancer Hospital-hematology department ( Site 3504) Zhengzhou Henan

+ 123 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06079879 on ClinicalTrials.gov ↗ ← All trials in the UK