
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial is comparing ruxolitinib with the best available treatment for people with high risk polycythaemia vera.
You have high risk if you have, or have had, a high
count and at least 1 of the following. You:
The best available treatment for people with polycythaemia vera is hydroxycarbamide or peginterferon alfa 2a. But these treatments can stop working. Or you might have side effects that affect your . In these cases your doctor will try other treatments.
Ruxolitinib is a called a cancer growth blocker. It blocks signals that cancer cells use to divide and grow.
Research shows that ruxolitinib can help people with polycythaemia vera when their initial treatment stops working. Or when their side effects affect their .
In this trial researchers want people to have ruxolitinib as their first treatment. They will compare it with hydroxycarbamide and peginterferon alfa 2a to find out:
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if you have, or have had, a high white blood cells count and one of the following apply. You:
And all of the following apply. You:
Who can’t take part
You cannot join this trial if any of these apply. You:
This is a phase 3 trial. The trial team need 586 people, with 293 people from both France and the UK to join.
It is a randomised trial. Neither you nor your doctor can choose which group you are in. The 2 groups are:
When you agree to join the trial your doctor talks to you about hydroxycarbamide and interferon alpha. They decide which might work best for you in case you are in the best available treatment group.
Ruxolitinib is a tablet. You take them twice a day with a full glass of water. Your doctor tells you how many to take.
You continue to have ruxolitinib for 3 years. You might be able to take it for longer if it is working and the side effects aren’t too bad.
Hydroxycarbamide are capsules. You take them with a full glass of water. You doctor tells you how many to take and when.
You have peginterferon alfa 2a as an injection under the skin (subcutaneous). You have it in the tummy (abdomen), thigh or top of your arm. A nurse can teach you to give yourself the injection at home. Or they can teach a family member. You must keep interferon alpha in the fridge. Your doctor tells you how much you need.
You continue to have hydroxycarbamide or peginterferon alfa 2a as long as they are working and the side effects aren’t too bad.
You have a diary to write down when you take your medication and how much. You must do this and bring the diary with you to every appointment at the hospital.
Quality of life
Researchers want to know how the treatment affects your quality of life. They ask you to fill in 3 questionnaires:
The questions ask about:
This is a quality of life study.
Samples for research
You give samples at the start and throughout the trial. These include:
Researchers use these samples to find out more about polycythaemia vera and its treatment. They also look for substances () in the samples that might tell them how well treatment is working.
You see the doctor to have tests before taking part. These tests include:
You see the doctor for blood tests and to see how you are at:
You then see the doctor:
You have an ultrasound of your spleen at year 1. You have a bone marrow sample at year 1 and year 3.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
When taking ruxolitinib there are certain medications, complementary therapies, foods and drinks you shouldn’t take. Your doctor will tell more about this.
The most common side effects of ruxolitinib can include:
Peginterferon alfa 2a can affect the . It may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening.
If you have any of these side effects, you should tell the doctor or nurse as soon as possible that you are on, or have been on, an .
We have information about:
Your trial doctor will talk to you about the possible side effects before you agree to take part in the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Claire Harrison
Novartis
University of Birmingham
MPN Voice
Institut National du Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.