Clinical Trials | A Phase 2/3, randomized, open-label, active-comparator-controlled, parallel-group, multicenter study to evaluate the safety and efficacy of bomedemstat (MK-3543) versus best available therapy in participants with polycythemia vera who have an inadequate response to or are intolerant to hydroxyurea

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with polycythemia vera who have an inadequate response to or are intolerant to hydroxyurea that has failed at least one prior line of cytoreductive therapy to lower hematocrit. The purpose of this study is to find out the safety and effectiveness of the investigational drug bomedemstat compared to standard treatment (ropeginterferon alfa-2b and ruxolitinib) and to determine if bomedemstat has an improved impact on your quality of life compared to the standard treatment. In this study, you will be randomized into one of two groups and receive bomedemstat or standard treatment. A computer will decide which group you are put in. You will have an equal chance of being put in either group. Attend trials visits to receive study drug and discuss your health history and how your are feeling. Tests will be run, such as an ECG, MRI, or CT scan, during the study visit and you will give blood and urine samples. You may also have additional bone marrow tests. You will be in the Treatment Phase for about 2 years. You will visit the trial site about every 2 weeks for the first 3 months. Then you will visit about once a month The most important risks related to the investigational drug bomedemstat are: • Change in sense of taste • Trouble passing stool or hard stools (constipation) • Frequent, loose, or watery stool (diarrhea) • Joint pain • Low number of blood cells such as platelets that help blood to clot (thrombocytopenia) • Feeling tired or having low energy • Bruising • Feeling sick to your stomach (nausea) • Feeling less hungry than usual You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. For questions, contact: [email protected]