Altinova

Researchers are evaluating the effectiveness and safety of givinostat compared to hydroxyurea in patients with high-risk polycythemia vera (PV) who have the JAK2V617F mutation. PV is a chronic condition that increases the risk of blood clots and can progress to more severe diseases like myelofibrosis or leukemia. High-risk patients are those aged 60 or older or those with a history of blood clots. Current treatments often do not fully control symptoms or long-term risks in these patients. The study involves two treatment groups receiving oral medications: givinostat or hydroxyurea. Dosages of both drugs are adjusted based on side effects or how well the treatment is working, aiming for an optimal dose. The core treatment phase is a pivotal phase 3 trial designed to show whether givinostat is more effective than hydroxyurea. Patients who finish this phase may continue receiving givinostat in an extended treatment phase to collect additional long-term safety and efficacy data. Participants will be assessed regularly, including monitoring blood counts and clinical response up to week 48. The main outcome measured is the proportion of patients who achieve a response by week 48, evaluated between weeks 25 and 48. Safety monitoring includes heart rhythm checks and other clinical evaluations. Eligible patients must meet specific criteria related to diagnosis, risk factors, and treatment needs, and those who complete the core phase successfully may enter the extended phase for further observation.