Posted 8 months ago by Wales Gene Park
Brief Summary: A phase III, randomised, open-label, Multicenter International Trial comparing ruxolitinib with either HydRoxycarbamIDe or interferon Alpha as first-line ThErapy for high-risk polycythemia vera (MITHRIDATE) Detailed Summary: The interventions are Arm A: Ruxolitinib and Arm B: Best Available Therapy (Hydroxycarbamide OR Interferon Alpha, any formulation permitted), which will be selected by the Investigator prior to randomisation. Randomisation will be in a 1:1 ratio and will be performed using a bespoke computer randomisation system developed by the Cancer Research UK Clinical Trials Unit (CRCTU) employing a stratified minimisation method. Patients will be stratified by: 1. Country of Origin: UK, France 2. Elected standard of care therapy: IFN, HC 3. Age: <60, ≥ 60 4. Prior thrombosis: No, Yes 5. Length of time from diagnosis: <5: ≥5 years 6. Cardiovascular risk factors, (including the following: arterial hypertension, diabetes, dyslipidemia, tobacco use, obesity): No, Yes Randomisation will be in a 1:1...