Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial of zanubrutinib for lymphoma of the brain and spinal cord (PRiZM+)
This trial is looking at zanubrutinib for
It is open to people whose lymphoma is a
- got worse during treatment or
- come back after treatment
More about this trial
Doctors can treat PCNSL with high doses of chemotherapy. Unfortunately for some people this doesn’t help and their lymphoma continues to get worse during treatment. For others the treatment helps but their lymphoma comes back sometime after they have finished treatment.
Researchers are looking for other treatments to help people in these situations.
Zanubrutinib is a
Other studies show that similar drugs to zanubrutinib can help people with PCNSL. Researchers want to find out if zanubrutinib can improve treatment.
The aims of the trial are to find out:
- how well zanubrutinib works for PCNSL
- what happens to zanubrutinib in the body
- how zanubrutinib affects the body
- more about the side effects
Who can enter
The following bullet points are a summary of 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 all of the following apply. You:
- have primary lymphoma of the brain and spinal cord that is a diffuse large B cell lymphoma (DLBCL) and has the CD20 protein. Your doctor will know if your lymphoma has this protein.
- have had treatment and the lymphoma continued to get worse during treatment or came back after treatment
- have lymphoma that the doctor can measure on an
- are up and about for more than half the day, can look after yourself but might not be able to work (performance status 0, 1 or 2). You might be able to join if because of the lymphoma you need help to look after yourself (performance status 3).
- are able to swallow capsules
- have satisfactory blood test results
- are willing to use contraception during the trial and for a time after if there is any chance you or your partner could become pregnant
- are able to give
informed consent. If you are not able to give informed consent due to the effects of the lymphoma a legal representative can do so on your behalf. Talk to your doctor or the trial team about this.
- are at least 16 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have or have had lymphoma in another part of the body
- have lymphoma that is only in the eye
- had chemotherapy for lymphoma within 2 weeks of starting zanubrutinib
- had radiotherapy to the whole of the brain within 4 weeks of starting zanubrutinib
- have already had a drug that works in the same way as zanubrutinib. Your doctor will know if you have.
- had another cancer in the past 2 years. This is apart from
non melanoma skin cancer, carcinoma in situof the breast or cervix or early prostate cancer (stage T1a or T1b) that was found due to looking at another health problem.
You cannot join this trial if any of these apply. You:
- are not able to have a
- have an active infection that needs treatment through a drip into a vein (
- have a bleeding problem such as haemophilia or severe Von-Willebrand disease
- are taking warfarin or you are taking 2 treatments to prevent blood clots. You can join if you are taking another treatment to prevent blood clots such as dabigatran and rivaroxaban or low molecular heparin. Ask your doctor about this if you are taking medication to thin the blood.
- have HIV. You might be able to join if you are taking anti retroviral drugs and blood tests show the HIV is undetectable. You need to talk to your HIV doctor about this.
- have hepatitis B. You might be able to join if blood tests show there is no sign of the virus in your blood. You need to talk to your doctor about this.
- have hepatitis C
heart problemsor breathing problems that your doctor thinks could affect you taking part
You cannot join this trial if you are pregnant or breastfeeding.
This is a phase 2 trial. The team need 20 people to take part.
Zanubrutinib is a capsule. You take it twice a day every day. You take 2 capsules unless your doctor tells you otherwise. You can take them with or without food.
Your doctor will talk to you about taking zanubrutinib and what to do if you accidentally miss a dose.
You continue to take zanubrutinib as long as it is helping and the side effects aren’t too bad.
Samples for research
You give extra blood samples during the trial. Where possible the trial team take these when you have bloods taken as part of your routine care.
The team will ask for samples of the fluid surrounding the brain and spine (CSF) when you have the
They also ask for a piece of the lymphoma tissue (
Researchers will or plan to use these samples to:
- see what happens to zanubrutinib in the body
- find out how zanubrutinib affects the body
- look for small pieces of lymphoma DNA (
ctDNA) in the blood and CSF
- find out more about primary lymphoma of the brain and spine
MRI scan for research
The team are looking at whether a certain type of
You see the doctor for tests before taking part. These tests include:
- blood tests
- lumbar puncture
- an examination to see how well your brain and nervous system is working (neurological examination)
- an MRI scan of the brain and spine
- eye examination
- PET-CT scan or CT scan
- heart trace (
You see the doctor regularly during the first 3 months of treatment. This is to:
- see how you are
- take blood tests
- find out if you are having any side effects
You then see the doctor every 3 months.
You have an MRI scan every 3 months.
You have a lumbar puncture after the start of treatment at:
- 1 week
- 2 weeks
- 4 weeks
- 8 weeks
At the end of treatment you see the doctor for a check up and blood tests. You also have:
- a neurological examination
- an MRI scan
You then continue to see the doctor every 3 months.
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.
The most common side effects of zanubrutinib are:
- a drop in blood cells causing an increased risk of infection, bleeding and bruising
- infections such as lung infections, urine infections, skin infection (cellulitis), flu and
- skin rash
- muscle and bone pain
- diarrhoea or constipation
- tiredness (fatigue)
- blood in the urine
- another cancer
- feeling sick
- high temperature (fever)
- high blood pressure
Your doctor will talk to you about the possible side effects of the treatment before you agree to take part.
How to join a clinical trial
Dr Christopher Fox
University of Birmingham