MK-3543-007 - A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) Versus Hydroxyurea in Cytoreductive Therapy Naïve Essential Thrombocythemia Participants

Studio Clinico

Patologia: Neoplasie ematologiche

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status
- 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 received no prior cytoreductive treatment for their ET
- Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
- Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable.

Criteri di esclusione: 

- History of any illness/impairment of gastrointestinal function that might interfere with drug absorption
- History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has an active infection requiring systemic therapy
- Has had a major surgery <4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery >4 weeks prior to first dose.

Trattamento sperimentale: 

Bomedemstat

Trattamento di controllo: 

Hydroxyurea

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-505232-36

Data di inserimento: 23.12.2024

Data di aggiornamento: 14.03.2025

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na