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

You might be able to join this study if you are 18 years or older and have been diagnosed with Polycythaemia Vera within the last 15 years, as long as it meets specific World Health Organisation (WHO) criteria. You also need to have ‘high-risk’ PV, which means you have a high white blood cell count and at least one other factor like being over 60, having had a previous blood clot or bleeding episode, a very high platelet count, or needing medication for high blood pressure or diabetes.

It’s important that your red blood cell count isn't too low, and you must not have been treated with more than one other drug for PV before, or had treatment for more than 10 years, unless it was just aspirin or blood letting. You also shouldn't be resistant or unable to tolerate any previous PV medication. You'll need to be generally well enough to take part and give your informed consent.

You wouldn't be able to join if your PV diagnosis was more than 15 years ago, if you don't have the JAK-2 gene change often seen in PV, or if you have certain other serious health issues like active infections (such as HIV or Hepatitis), uncontrolled cancers, or severe mental health conditions. Pregnant or breastfeeding individuals, or those with certain allergies, also wouldn’t be able to participate. If you are sexually active, you and your partner must agree to use effective contraception during the study and for a period afterwards.

If you decide to take part in this study, you will first undergo a series of checks to confirm you meet all the requirements. Once enrolled, you will be randomly assigned to one of two treatment groups: you'll either receive ruxolitinib or one of the standard treatments (hydroxycarbamide or interferon). Neither you nor your doctor will get to choose which group you are in, as this is decided by chance to ensure the study is fair.

The specific details on the number of clinic visits, tests, and the total length of your participation will be explained in full by the study team. You'll regularly see the study doctors and nurses for blood tests and other assessments to monitor your health and how well the treatment is working. This also involves ensuring that any side effects are managed safely. You will continue to receive your assigned medication throughout the study period, and detailed instructions will be provided on how to take it. Regular follow-up appointments will continue even after you finish the main treatment phase.