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
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.
Arms & interventions
- DrugBomedemstat
10, 15, 20, and 50 mg oral capsules
Outcome measures
Primary
Percentage of participants with one or more adverse events (AEs)
An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants with AEs will be presented.
Time frame: Up to ~10 years
Percentage of participants who discontinued study treatment due to an AE
An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who discontinued study treatment due to an AE will be presented.
Time frame: Up to ~10 years
Secondary
For participants with ET or PV: Duration of clinicohematologic response
Time frame: Up to ~10 years
For participants with ET or PV: Duration of hematologic remission
Time frame: Up to ~10 years
For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML
Time frame: Up to ~10 years
For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML
Time frame: Up to ~10 years
For participants with MF, ET, or PV: Percentage of participants with thrombotic events
Time frame: Up to ~10 years
For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events
Time frame: Up to ~10 years
Eligibility criteria
Study locations (4)
University of Michigan ( Site 6000)
Ann Arbor, Michigan, 48109
DUHS Duke Blood Cancer Center ( Site 6005)
Durham, North Carolina, 27705
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
Columbus, Ohio, 43210
UPMC Hillman Cancer Center ( Site 6004)
Pittsburgh, Pennsylvania, 15232