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 (Jun 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
Treatments studied
Targeted therapy
Other
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.
Frequently asked questions
Is NCT04116502 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cytoreductive therapy, JAK inhibitor disqualifies patients from enrollment.
Does this trial require JAK2?
Yes, JAK2 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages