The trial will be a phase III, randomised-controlled, multi-centre, international, open-label trial consisting of ruxolitinib versus best available therapy, where best available therapy is a choice of interferon alpha, any formulation permitted (IFN) or hydroxycarbamide (HC), and which will be elected by the Investigator prior to randomisation.
Age >60 years
Prior thrombosis or haemorrhage
Platelet count >1000 x 10^9/l*
Hypertension or diabetes requiring pharmacological therapy (*At any time since diagnosis)
Diagnosis of PV > 15 years previously
Absence of JAK-2 mutation
Patients with any contraindications to any of the investigational medical products
Treatment with >1 cytoreductive therapy OR a cytoreductive treatment duration exceeding 10 years OR resistance/intolerance to that therapy
University of Birmingham
Lead sponsor
Novartis
Collaborator
MPN Voice
Collaborator
National Cancer Institute, France
Collaborator