Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at ruxolitinib to treat polycythaemia vera and essential thrombocythaemia (MAJIC)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called ruxolitinib to treat high risk polycythaemia vera (PV) and high risk essential thrombocythaemia (ET).
Polycythaemia vera and essential thrombocythaemia are
More about this trial
Doctors usually treat these conditions with hydroxycarbamide. Unfortunately some people can’t take hydroxycarbamide and sometimes the disease stops responding to it. So researchers are looking for other treatments.
We know from research that ruxolitinib may help people with PV and ET.
The aims of this trial are to find out
- How well ruxolitinib works for people with polycythaemia vera and essential thrombocythaemia who can’t have hydroxycarbamide
- How safe it is
Who can enter
You may be able to enter this trial if you are considered to have high risk polycythaemia vera or high risk essential thrombocythaemia for any 1 of the following reasons
- You are over 60 years old
- You have had blood clots or periods of sore, red hands or feet, or you have had migraines needing medication after being diagnosed with PV or ET, or in the10 years before being diagnosed
- You have a very large
- You have a high number of platelets in your blood
- You have diabetes or high blood pressure if you’ve needed to take medication for more than 6 months
- You have had bleeding caused by your essential thrombocythaemia
- Your PV or ET has stopped responding to hydroxycarbamide or you can’t take it for some reason
- Your other blood test results are satisfactory
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You are willing to use reliable contraception if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if
- Your polycythaemia vera or essential thrombocythemia has transformed into
- You have had a heart attack in the last 6 months, or certain other heart problems
- You have already had ruxolitinib
- You are pregnant or breastfeeding
This is a phase 2 trial. It will recruit 190 people with PV and 116 people with ET, making a total of 306 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.
People in group 1 have ruxolitinib. If you are in group 2, your doctor will talk to you about which treatment is best for you. This may include continuing to take hydroxycarbamide, or having drugs such as anagerlide, interferon, busulfan or 32P. This is called best available therapy.
Ruxolitinib is a tablet. You take it twice daily with a glass of water. You keep a diary to record when you take the tablets. You take ruxolitinib for at least 1 year. You can continue to have it for up to 5 years if it is helping you and your doctor thinks it is the best treatment for you.
The trial team will ask you to fill out a questionnaire before you start treatment, after 2 months and 4 months, and then every 4 months for 5 years. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
The researchers will ask to take a swab from the inside of your mouth before you start treatment. You must agree to this to take part in this trial.
They will also take blood samples every 4 months for 5 years. And you have a bone marrow test every year for 5 years. You must agree to these for the first year. If you don’t you can’t take part in the trial. After the first year if you don’t want to give the blood samples or have the bone marrow test for this study, you don’t have to. You can still take part in the trial.
You see the doctor and have some tests before taking part in this trial. These test include
- A physical examination
- Blood tests
- Heart trace (
- Bone marrow test
- Ultrasound of your tummy (abdomen)
You see your doctor every 2 weeks for 3 months to have a physical examination and blood tests.
If you are having 'best available therapy' and your doctor thinks it is okay, you may see them every month for 3 months, rather than every 2 weeks. if you don't attend every 2 weeks your doctor will phone you to see how you are.
You then see your doctor every 6 weeks for 9 months.
If you continue having ruxolitinib after 1 year, you see the doctor every 2 months
If you are having best available therapy after 1 year, you see the doctor at least every 4 months.
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.
Prof Claire Harrison
Cambridge Blood and Stem Cell Biobank
Experimental Cancer Medicine Centre (ECMC)
Guy's and St Thomas' NHS Foundation Trust
NIHR Clinical Research Network: Cancer
University of Birmingham