"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at ruxolitinib as treatment for polycythaemia vera (The RELIEF study)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Polycythaemia vera is a condition in which the
Doctors usually treat PV with hydroxycarbamide. But some people still have symptoms such as tiredness, itching, aching muscles and sweating. So researchers are looking for other treatments.
The aims of this trial are to find out
- If ruxolitinib helps reduce the symptoms of polycythaemia vera more than hydroxycarbamide
- How safe it is
Who can enter
You may be able to enter this trial if you
- Have polycythaemia vera and have symptoms of tiredness, itching, aching muscles or sweating
- Have been taking hydroxyurea for at least 12 weeks and have been on a stable dose for at least 4 weeks
- Have satisfactory blood test results
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are at least 18 years old
- Are willing to use reliable contraception during the trial and for more than a month after stopping the trial drug if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have had whole blood removed to reduce the number of red blood cells more than twice in the last 6 months and your
spleencan be felt by your doctor
- Have liver or kidney problems
- Are pregnant or breastfeeding
This phase 3 trial will recruit about 100 people.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.
- People in group A have ruxolitinib tablets twice a day and a dummy tablet (placebo) instead of hydroxycarbamide
- People in group B have hydroxycarbamide tablets and a placebo instead of ruxolitinib
The number of hydroxycarbamide (or placebo) tablets you take will be the same as the dose you were taking before joining the trial.
If your symptoms don’t get any better, the trial team may increase the dose of either drug after 4 weeks and again after 8 weeks.
You have an electronic diary (e-Diary) to keep at home. This is about the same size as a mobile phone. It has an alarm that will go off each evening to remind you to fill it in. Using the e-Diary, you answer some questions about any symptoms you have. You then plug it in to send the information to a database. The trial team will ask you to bring the e-Diary to each appointment you have with them.
You will also be asked to fill out a questionnaire before you start treatment, at your hospital visits during treatment and when you finish treatment. The questionnaire will ask about any side effects you have had and how you have been feeling. This is called a quality of life study.
People in both groups take the tablets for 16 weeks. You and your doctors will then find out within about 2 weeks if you are in group A or group B. If you find out that you were in group A, and the trial team think you are getting some benefit from ruxolitinib, you can carry on taking it for as long as it helps you.
If you were in group B, you may be able to start taking ruxolitinib. This will depend on your blood test results at the time. If your symptoms don’t get any better, the dose can be increased after 4 weeks and again after 8 weeks.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Urine tests
- Heart trace (
During the first 16 weeks of treatment, you see the trial doctors every 4 weeks. You have a physical examination and blood tests each time.
If you take ruxolitinib after the first 16 weeks, you see the trial team again in weeks 24, 36, and 48. After that you see them every 12 weeks until everybody in this part of the study has completed 48 weeks of treatment.
When you stop taking ruxolitinib, you see the trial team again about a month later. You have a physical examination, a heart trace, blood tests and urine tests.
The side effects of ruxolitinib include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Urine infections
- Weight gain
- Wind (flatulence)
- A viral skin infection called herpes zoster
- Liver damage
- An increase in the level of cholesterol in your blood
If you stop taking ruxolitinib, your doctor may gradually decrease the dose in case stopping suddenly makes your symptoms worse.
The side effects of hydroxycarbamide include
- Hair loss
- Sore mouth or lips
- Loss of appetite
- Feeling sick
- Redness of the face
- A drop in blood cells causing an increased risk of infection, bleeding problems, bruising, tiredness and breathlessness
- Blood in your urine or pain when passing urine
- Chills or high temperature (fever)
- Inflammation of the
- Back or tummy (abdominal) pain
- Cough or sore throat
- Shortness of breath
- Sores on your skin and skin cancer
People who take hydroxycarbamide for a long period of time as treatment for polycythaemia vera may develop leukaemia. Elderly people are more sensitive to the side effects of hydroxycarbamide.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Yasmin Hasan
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)