Phase 3 Study Comparing Givinostat and Hydroxyurea in High-risk Polycythemia Vera Patients with JAK2V617F Mutation

What this Trial Is About

Researchers are evaluating the efficacy and safety of givinostat compared to hydroxyurea in patients with high-risk polycythemia vera PV who have the JAK2V617F mutation. PV is a chronic blood disorder that increases the risk of blood clots, progression to myelofibrosis, and transformation into acute leukemia. Patients aged 60 or older or those with a prior thrombotic event are considered high risk. Current treatments with hydroxyurea often do not fully control symptoms or long-term risks. Participants will be randomly assigned to receive either oral givinostat at 50 mg twice daily or hydroxyurea at 500 mg twice daily for 48 weeks. Dosages may be adjusted based on side effects or lack of effectiveness. After this core treatment phase, eligible patients can enter an extended treatment phase to receive long-term givinostat, allowing collection of additional safety and efficacy data. Throughout the study, participants will have regular visits to monitor blood counts, spleen size, and treatment responses. Researchers will assess the proportion of patients achieving a response at week 48, including complete hematological response and spleen size normalization. Safety and tolerability will be evaluated up to week 48. The study aims to collect comprehensive data on treatment effects and patient outcomes over time.

Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera