Bomedemstat vs Best Available Therapy (BAT) for Essential Thrombocythemia
- Conditions
- Essential Thrombocythemia patients who have an inadequate response to or are intolerant of hydroxyureaMedDRA version: 21.0Level: LLTClassification code: 10015494Term: Essential thrombocythemia Class: 10029104Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-504865-21-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 380
Has a diagnosis of essential thrombocythemia (ET) per World Health Organization (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 per at least 1 of the following criteria, based on modified 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 × 109/L (450k /µL) assessed up to 72 hours before first dose of study intervention
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, History of any illness/impairment of gastrointestinal (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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method