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
Merck Sharp & Dohme LLC
Summary
The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: * Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; * Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission. No hypothesis testing will be conducted in this study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugBomedemstat
10, 15, 20, and 50 mg oral capsules
Locations (21)
- University of Michigan ( Site 6000)Ann Arbor, Michigan
- DUHS Duke Blood Cancer Center ( Site 6005)Durham, North Carolina
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)Columbus, Ohio
- UPMC Hillman Cancer Center ( Site 6004)Pittsburgh, Pennsylvania
- Royal Prince Alfred Hospital ( Site 1003)Camperdown, New South Wales
- Royal North Shore Hospital ( Site 1001)St Leonards, New South Wales