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MITHRIDATE: A phase III, randomised, open-label, Multicenter International Trial comparing ruxolitinib with either HydRoxycarbamIDe or interferon Alpha as first line ThErapy for high risk polycythemia vera

Study ID: 39201
Short Title: MITHRIDATE Trial Version 2.0 10-June-2019
Trust Name: UHD,UHS
Recruitment Site: Royal Bournemouth Hospital,Southampton General Hospital
Disease Area: Haematology
Phase: III
Expected End Date: 30/09/2029
Postcode: SO16 6YD
BH15 2JB
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

1. Patient > = 18 years of age 2. Diagnosis of PV meeting the WHO criteria within the past 10 years 3. Meets criteria of high risk* PV ( High risk PV defined as WBC > 11 x 109/l* AND at least ONE of the following: -Age > 60 years -Prior thrombosis or major haemorrhage related to disease -Platelet count > 1000 x 109/l* -Diagnosed < 10 years -Received treatment for < 5 years) 4. Patients may have received antiplatelet agents and venesection 5. Patients may have received ONE cytoreductive therapy for PV less than 5 years (BUT they should not be resistant or intolerant to that therapy) 6. Able to provide written informed consent.

1. Diagnosis of PV > 10 years previously 2. Absence of JAK-2 mutation 3. Patients with any contraindications to any of the investigational medical products 4. Treatment with > 1 cytoreductive therapy OR a cytoreductive treatment duration exceeding 5 years OR resistance/intolerance to that therapy 5. Active infection including hepatitis B, hepatitis C, Tuberculosis 6. Pregnant or lactating patients (Women of childbearing potential must have a negative urine or blood Human Chorionic Gonadotropin pregnancy test prior to trial entry) 7. Patients and partners of childbearing potential not prepared to adopt highly effective contraception measures (if sexually active) whilst on treatment and for at least 6 months after completion of study medication 8. ECOG Performance Status Score > = 3 9. 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 ( New York Heart Association) Class II 10. Patients who have transformed to myelofibrosis 11. Previous treatment with ruxolitinib 12. Previous (within the last 12 months) or current platelet count < 100 x 109/L or neutrophil count < 1 x 109/L not due to therapy 13. Inadequate liver function as defined by ALT/AST > 2.0 x ULN 14. Inadequate renal function as defined by eGFR < 30 mls/min 15. Unable to give informed consent

Polycythemia vera (PV) is a rare blood cancer characterised by a high-risk of thrombosis (clotting) and haemorrhage (bleeding). Average survival in high-risk patients receiving contemporary care is 10.9 years. Current treatments include aspirin, venesection (blood drawing) and selected use of standard therapies (hydroxycarbamide (HC) or interferon alpha (IFNa)). The strategies remain less than perfect, with on-going risks of developing blood clots, bleeding, dying early due to either these events or to the disease progressing into leukaemia or a more aggressive form (myelofibrosis). Approximately 9 out of 10 people who have PV have a change in the JAK2 gene. The JAK2 gene makes a protein that controls how many blood cells the stem cells make. Ruxolitinib, the drug being tested in this trial, targets the JAK pathway to stop the JAK2 gene signalling to the stem cells to make blood cells. Ruxolitinib appears to help patients with PV whether they have the JAK2 mutation or not. MITHRIDATE is therefore an important trial as it aims to answer whether ruxolitinib, is better than the Best Available Therapy (BAT) HC or IFNa to improve outcomes for patients with PV. Patients will be randomised between ruxolitinib and BAT. 586 patients with high risk PV who meet the eligibility criteria will be recruited from the UK and France. All patients will be assessed for response throughout and will attend clinic visits seven times in the first year and every 3 months throughout year 2 and 3. Patients on either treatment will continue on the drug until the last patient finishes treatment or until the primary endpoint is reached,or end of study is declared, whichever is sooner. The research is funded mainly by Novartis who will be providing the drug free of charge. There is also some funding from MPN Voice (a charity) and The French National Cancer Institute.

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