MK-3543-017 - A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study

Studio Clinico

Patologia: Neoplasie ematologiche

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: III

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready
- Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
- ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
- Is not currently on a dose hold
- Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat.

Criteri di esclusione: 

- Has received prohibited concomitant medications
- Ongoing or planned participation in another investigational study
- Has noncompliance in prior bomedemstat study receiving <90% of assigned doses excluding suspensions or holds as assigned by the investigator.

Trattamento sperimentale: 

Bomedemstat

Trattamento di controllo: 

-

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-506996-89 - NCT06351631

Data di inserimento: 23.09.2024

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