Last updated 15 days ago

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)

300 patients around the world
Available in Spain, Colombia, United States
Merck Sharp & Dohme LLC
3Research sites
300Patients around the world

This study is for people with

Myeloproliferative syndromes
Essential thrombocythemia

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Has a diagnosis of ET per WHO 2016 diagnostic criteria for myeloproliferative neoplasms.
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.
Has a history of inadequate response to or intolerance of hydroxyurea based on modified European LeukemiaNet (ELN) criteria for hydroxyurea resistance or intolerance: hydroxyurea resistance (or inadequate response) or hydroxyurea 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 lines of therapy including hydroxyurea.
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.

Sites

Hospital Universitario Austral - Pilar
Recruiting
Av. Juan Domingo Perón 1500, Pilar, Buenos Aires
Sanatorio 9 de Julio - Tucumán
Sanatorio 9 de Julio - Tucumán
Recruiting
San Juan 537, San Miguel de Tucumán, CP 4000
Oncomédica - IMAT - Montería
Recruiting
Carrera 6 # 72 – 34 - Montería
LinkedinInstagramFacebook
Terms and ConditionsPrivacy Policy