MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera
Key claim: The MITHRIDATE phase III RCT is comparing ruxolitinib versus interferon alpha or hydroxycarbamide as first-line therapy in high-risk polycythemia vera patients.
Abstract
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.
Why this matters
High-risk PV currently lacks head-to-head randomised evidence to choose between hydroxycarbamide, interferon alpha, and ruxolitinib as frontline cytoreduction, with practice driven largely by single-arm or two-way comparisons (e.g., MAJIC-PV, RESPONSE, PROUD-PV). MITHRIDATE is the first three-arm phase III RCT in this subtype, so its readout will be uniquely positioned to reset the PV-specific natural history and prognostic landscape captured on this wiki page. Until results emerge, the relevance is in flagging that subtype-specific frontline standard of care for high-risk PV is an open question under active prospective adjudication.