OncoMatch/Clinical Trials/NCT04116502
MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera
Is NCT04116502 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Ruxolitinib and Hydroxycarbamide for polycythemia vera.
Treatment: Ruxolitinib · Hydroxycarbamide · Interferon-Alpha — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myeloproliferative Neoplasm
Biomarker criteria
Required: JAK2 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: antiplatelet agent
Patients may have received antiplatelet agents
Must have received: venesection
Patients may have received venesection
Cannot have received: cytoreductive therapy
Exception: ONE cytoreductive therapy for PV less than 10 years (not resistant or intolerant)
Treatment with >1 cytoreductive therapy OR a cytoreductive treatment duration exceeding 10 years OR resistance/intolerance to that therapy
Cannot have received: JAK inhibitor (ruxolitinib)
Previous treatment with ruxolitinib
Lab requirements
Blood counts
platelet count ≥ 100 x 10^9/L; neutrophil count ≥ 1 x 10^9/L (not due to therapy); screening haemoglobin >8g/dl
Kidney function
eGFR ≥ 30 mls/min
Liver function
ALT/AST ≤ 2.0 x ULN
Cardiac function
No uncontrolled rapid or paroxysmal atrial fibrillation, uncontrolled or unstable angina, recent (within the last 6 months) myocardial infarction or acute coronary syndrome or any clinically significant cardiac disease > NYHA Class II
screening haemoglobin of >8g/dl; previous (within the last 12 months) or current platelet count <100 x 10^9/L or neutrophil count < 1 x 10^9/L not due to therapy [excluded]; Inadequate liver function as defined by ALT/AST >2.0 x ULN [excluded]; Inadequate renal function as defined by eGFR < 30 mls/min [excluded]; Uncontrolled rapid or paroxysmal atrial fibrillation, uncontrolled or unstable angina, recent (within the last 6 months) myocardial infarction or acute coronary syndrome or any clinically significant cardiac disease > NYHA Class II [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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