Polycythemia Vera Clinical Trial
Official title:
A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bomedemstat in Patients With Polycythemia Vera (PV)
This is a Phase 2 open label study of an orally administered lysine-specific demethylase 1 (LSD1) inhibitor, bomedemstat, in participants with polycythemia vera. The primary hypothesis is that bomedemstat is a safe and tolerable orally available agent when administered to participants with PV; and inhibition of LSD1 by bomedemstat will induce hematologic response in this population by 36 weeks, improve symptom burden and reduce spleen size in participants with enlarged spleen at baseline. With Amendment 3, after all ongoing patients have reached 52 weeks of treatment, eligible patients may transition to a bomedemstat extension study if available.
This is a Phase 2 multi-center, open-label study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of bomedemstat administered orally once daily in participants with PV. Participants will receive 36 weeks of dosing and may qualify for additional treatment thereafter. Participants will be followed closely throughout the study for both adverse events by frequent monitoring of clinical signs and symptoms as well as safety labs. Efficacy and pharmacodynamic effects will be closely monitored by frequent hematology assessments of peripheral blood. Throughout dosing, transfusions or phlebotomy may be administered if needed in accordance with standard institutional guidelines. To ensure safety, a Safety Advisory Board will perform periodic reviews of safety parameters and pharmacodynamic markers. ;
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