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Clinical Trial ยท PHASE3 ยท Recruiting

MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera

26 October 2026 NCT04116502 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE3
Participants
ALL
Age Range
18 Years+

About This Trial

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.

Who Can Join?

Population: High risk PV defined as WBC >11 x 10^9/l* AND at least ONE of the following * 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) Inclusion Criteria: 1. Patient โ‰ฅ18 years of age 2. Diagnosis of PV meeting the WHO criteria within the past 15 years 3. Meets criteria of high risk* PV (see above for specific population) 4. Patients must have a screening haemoglobin of >8g/dl 5. Patients may have received antiplatelet agents and venesection 6. Patients may have received ONE cytoreductive therapy for PV less than 10 years (BUT they should not be resistant or intolerant to that therapy) 7. Able to provide written informed consent Exclusion Criteria: 1. Diagnosis of PV > 15 years previously 2. Absence of JAK-2 mutation 3. Patients with any contraindications to any of…

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