RecruitingPhase 3NCT04116502

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

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


Sponsor

University of Birmingham

Enrollment

586 participants

Start Date

Oct 25, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for treating high-risk polycythemia vera (PV), a blood condition where the bone marrow makes too many red blood cells. It tests whether ruxolitinib (a targeted drug) works better than the standard treatments (hydroxycarbamide or interferon). **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with polycythemia vera within the past 15 years - Your disease is "high risk," meaning you have a high white blood cell count AND at least one of the following: age over 60, prior blood clots or bleeding, very high platelet count, or hypertension/diabetes requiring medication - You have received at most one prior medication for PV (for less than 10 years), and you are not resistant or intolerant to it **You may NOT be eligible if...** - You were diagnosed with PV more than 15 years ago - You do not have the JAK2 genetic mutation - You have been treated with more than one cytoreductive (cell-reducing) therapy or for more than 10 years - You are pregnant or breastfeeding - You have active infections such as HIV, hepatitis B or C, or tuberculosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRuxolitinib

10mg of ruxolitinib twice daily (bd)

DRUGHydroxycarbamide

Via standard hospital mechanisms

DRUGInterferon-Alpha

Any formulation, via standard hospital mechanisms


Locations(47)

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Royal United Hospital

Bath, United Kingdom

Belfast City Hospital

Belfast, United Kingdom

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Blackpool Victoria Hospital

Blackpool, United Kingdom

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Southmead Hospital

Bristol, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

Kent and Canterbury Hospital

Canterbury, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

St Richard's Hospital

Chichester, United Kingdom

Colchester Hospital

Colchester, United Kingdom

Castle Hill Hospital

Cottingham, United Kingdom

Russells Hall Hospital

Dudley, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Gloucestershire Royal Hospital

Gloucester, United Kingdom

Calderdale Royal Hospital

Halifax, United Kingdom

Huddersfield Royal Infirmary

Huddersfield, United Kingdom

Raigmore Hospital

Inverness, United Kingdom

Kettering General Hospital

Kettering, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

St John's Hospital

Livingston, United Kingdom

University College Hospital

London, United Kingdom

Guy's Hospital

London, United Kingdom

St George's Hospital

London, United Kingdom

Wythenshawe Hospital

Manchester, United Kingdom

Arrowe Park Hospital

Metropolitan Borough of Wirral, United Kingdom

The James Cook University Hospital

Middlesbrough, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Royal Gwent Hospital

Newport, United Kingdom

North Tyneside General Hospital

North Shields, United Kingdom

Northampton General Hospital

Northampton, United Kingdom

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Royal Berkshire Hospital

Reading, United Kingdom

Halton Hospital

Runcorn, United Kingdom

Wexham Park Hospital

Slough, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

Sunderland Royal Hospital

Sunderland, United Kingdom

Good Hope Hospital

Sutton Coldfield, United Kingdom

Royal Cornwall Hospital

Truro, United Kingdom

Warwick Hospital

Warwick, United Kingdom

New Cross Hospital

Wolverhampton, United Kingdom

Worthing Hospital

Worthing, United Kingdom

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