ClinicaliQ Trial Snapshot
- MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera — Recruiting • Phase III • Oncology • NCT04116502.
- Treatment being tested: Ruxolitinib (a JAK1/2 inhibitor) compared against standard first-line therapies (hydroxycarbamide or interferon-alpha) in newly diagnosed high-risk polycythemia vera patients.
- Patient eligibility overview: High-risk polycythemia vera patients who are treatment-Phase IIIïve and suitable for first-line therapy; risk stratification likely based on age, thrombotic history, and JAK2V617F mutation status according to current diagnostic criteria.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- 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:
- Patient ≥18 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.