Clinical Trials | 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

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with essential thrombocythemia (ET). ET is a type of blood disorder. In ET, the bone marrow makes too many platelets. Platelets are a type of blood cell. They help blood to clot. The purpose of this study is to test experimental bomedemstat or hydroxyurea in people with essential thrombocythemia (ET). The study will test the safety, how well bomedemstat works compared to hydroxyurea and how well bomedemstat works to manage fatigue and other symptoms of ET compared to hydroxyurea. If you decide to take part in this research study, you will undergo a series of tests in screening phase to determine whether you meet the entry criteria. If you are enrolled into this study, you will get either bomedemstat and placebo for hydroxyurea or hydroxyurea and placebo for bomedemstat based on which group you are placed. There are 2 treatment phases, initial treatment phase and extended treatment phase. After you complete the trial visits during the Initial Treatment Phase and/or Extended Treatment Phase, you will be in the Follow-up Phase. All participants will have 1 follow-up visit. The most important risks or discomforts that you may expect from bomedemstat include change in the taste of foods or liquids, difficulty having a bowel movement, joint pain, low number of blood cells (platelets) that help to clot blood which may increase your risk of bleeding or bruising, feeling tired or low energy, diarrhea. The most common risks associated with hydroxyurea include infection, anemia which may causes tiredness, or may require transfusion, bruising, bleeding, headache. The risks of bone marrow aspirate or biopsy include bleeding, infection, local nerve damage, pain. 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. We expect that your taking part in this research will last for about 3 years. During the study you will undergo tests and procedures including: • Full physical examination • 12-lead ECG • Blood for safety assessments and urine or serum for pregnancy • Bone marrow aspirate and biopsy • Blood for pharmacokinetics and biomarker assessments For questions, contact: [email protected]