A trial looking at ibrutinib with and without treatment breaks for chronic lymphocytic leukaemia (STATIC)
Cancer type:
Status:
Phase:
This trial is comparing the targeted cancer drug ibrutinib with, and without, treatment breaks. It is for people with either:
- chronic lymphocytic leukaemia (CLL)
- small lymphocytic lymphoma (SLL)
It is for people who have already taken ibrutinib either:
- in the FLAIR trial or
- on the NHS because their CLL or SLL did not go away with their first treatment or it has come back
More about this trial
The most common treatments for chronic lymphocytic leukaemia (CLL) are 
. Targeted cancer drugs can change the way that cells work and help the body control the growth of cancer.
Ibrutinib is a type of targeted cancer drug called a cancer growth blocker. It stops signals that cancer cells use to divide and grow. Doctors use this to treat people with CLL that has either:
- come back or
- not gone away with their first treatment
Ibrutinib often works well for people when taken every day. You can take it until there are signs that the CLL has come back. Targeted cancer drugs tend to have fewer side effects than . But people often take targeted drugs such as ibrutinib continuously for several years. This means people may find any side effects a challenge to cope with for long periods of time.
There is some evidence that if ibrutinib is taken for several years that the leukaemia is more likely to become to the drug. Doctors don’t know if taking breaks in ibrutinib treatment would stop or reduce the chance of this happening. Researchers are doing this trial to try and find out.
This main part of this trial is for people who are taking ibrutinib and it is working well. These are people in groups called the:
- front-line randomisation group and
- previously treated patients group
The trial is also for people who have had ibrutinib in the FLAIR trial and their leukaemia is getting worse. This group is also called the clinical need group.
The main aims of the trial are to find out:
- if having a break from ibrutinib works as well as taking it continuously
- if having a break from ibrutinib makes it less likely that the CLL becomes resistant to the drug
- more about the side effects of treatment
- about the
quality of life of people taking part - about the overall cost of the two different ways of having treatment
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 either chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
- are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- have satisfactory blood test results
- are willing to use reliable contraception during treatment and for 3 months after treatment if there is any chance you or your partner could become pregnant
- agree not to donate eggs or sperm during treatment and for 3 months after treatment
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have leukaemia that has transformed into Richter’s syndrome
- have leukaemia in your brain or spinal cord
- have severe and long-lasting low levels of blood cells in your bloodstream (pancytopenia). You may be able to take part if this is because you have leukaemia cells entering your
bone marrow . Your doctor can explain more. - have active and uncontrolled breakdown of your red blood cells (haemolysis)
- need treatment with a type of medicine called CYP3A inhibitor or inducer. Your doctor will know more.
- have started treatment with two or more medicines to lower your
platelet level recently. You might be able to take part if you have been taking the same dose for at least 3 months before joining the trial.
Medical conditions
You cannot join this trial if any of these apply. You:
- have galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- have had major surgery within 4 weeks of taking part in the trial. This is within 4 weeks of
randomisation or joining the trial depending on your circumstances. Your doctor can tell you more. - have an active infection
- have heart failure
- have hepatitis B or hepatitis C
- have serious breathing problems such as widening of the lung airways (bronchiectasis) or severe
COPD - have had a
stroke or bleed on the brain within 6 months of joining the trial - have any other medical condition or mental health problem that the trial team think could affect you taking part
- are taking any heart medicines called ACE inhibitors at the moment. Your doctor will know this.
Other
You cannot join this trial if any of these apply. You:
- are pregnant, breastfeeding or planning a pregnancy
- have had a
live vaccine in the 4 weeks before joining the trial or while taking part in the trial - are taking steroids. You might be able to take part if your dose is low. Your doctor can explain more.
- are taking medication to thin your blood, such as warfarin
As well as the above, each study group has different entry criteria.
Clinical need group
Who can take part
You may be able to join this group if all of the following apply:
- you are taking ibrutinib and are nearing the end of, or have finished, 6 years of ibrutinib treatment on the FLAIR trial
- your CLL is getting worse, or coming back, after 6 years of ibrutinib on the FLAIR trial (before you join STATIC)
Who can’t take part
You cannot join this trial if any of these apply. You:
- have CLL which needs a different treatment than ibrutinib
- have had any treatment other than ibrutinib for CLL after taking part in FLAIR
- are able to take join the front line randomisation group
Front-line randomisation group
Who can take part
You may be able to join this group if all of the following apply:
- you are taking ibrutinib in the FLAIR trial or have finished 6 years of ibrutinib treatment on the FLAIR trial
- there is no sign of your CLL. Your doctor can not feel your
spleen , or any lymph nodes . Your number of lymphocytes has also been satisfactory for at least a year before randomisation .
Who can’t take part
You cannot join this group if any of these apply:
- your CLL is getting worse
- you have had a break from ibrutinib for more than 28 days in the 12 months before randomisation. You might be able to take part if you have finished ibrutinib treatment in the FLAIR trial and you have had a break for longer than 28 days in the last 12 months. Your doctor will know more.
Previously treated patients
Who can take part
You may be able to join this group if all of the following apply:
- have been taking ibrutinib for at least the past 3 years
- there is no sign of your CLL. Your doctor can not feel your
spleen , or any lymph nodes . Your number of lymphocytes has also been satisfactory for at least a year before randomisation
Who can’t take part
You cannot join this group if any of these apply:
- your CLL is getting worse
- you have had a break from ibrutinib for more than 28 days in the 12 months before randomisation
- have a problem with your kidney function
- have any other medical problem, such as another type of cancer, that may mean you are unlikely to live for more than 5 years
Trial design
Clinical need group
The researchers think that a small number of people at the end of their treatment on the FLAIR trial will need to continue to take ibrutinib. This is because their CLL is not well controlled enough for them to take part in a trial where they might have to stop it.
If this is the case for you, you can continue taking ibrutinib in this trial - STATIC. You take it continuously for as long as it is working, and the side effects are not too bad. This part of the study is called the ‘clinical need group’. Information from this group will help researchers understand more about the long-term benefits and side effects of ibrutinib.
You see your doctor every 3 months in clinic for a check up and blood tests. This is the same as your usual care in the NHS.
Everyone else takes part in the randomised part of the trial.
Front-line randomisation group and previously treated patients group
This is a phase 3 trial. The team need 800 people to take part from the UK.
This is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor will be able to decide which group you are in.
There are 2 groups:
- pausing ibrutinib
- continuous ibrutinib
Pausing ibrutinib
You take a break from ibrutinib, and only restart if your CLL comes back. If ibrutinib controls your CLL again you will be able to take another break.
Continuous ibrutinib
You continue to have ibrutinib every day for as long as it is working, and the side effects are not too bad.
Both groups
You have between 3 and 9 years of treatment depending on when you join the trial. You have treatment in the trial for as long as it is working, and the side effects are not too bad.
You see your doctor every 3 months in clinic. You have a check up and blood tests to see how you are and if you have any signs of CLL. This is the same as your usual care in the NHS.
Samples for research
You have blood taken at certain points before and during treatment as part of the trial. These samples are taken at the same time as your usual blood tests.
The researchers use the samples to look for any changes in the CLL cells. This is to understand more about CLL and:
- why ibrutinib works better for some people than others
- to try and improve treatment in the future
UK CLL Trials Biobank research
The trial team ask you to have extra blood tests, and one saliva test, at certain points before and during treatment. You give the samples at the same time as your usual blood tests. These samples are stored at the UK CLL Trials Biobank.
These samples may be used to look at why CLL develops resistance to ibrutinib.
Taking part in this research is optional. You can say no and still take part in this trial.
Questionnaires
The trial team will ask you to fill out questionnaires:
- before you start treatment
- every 3 months for the first 6 months
- every 6 months until the end of the trial
The questionnaires will ask about:
- side effects and how you’ve been feeling. This is called a quality of life study.
- healthcare services you have used in relation to your CLL
You can choose to fill in your questionnaires on paper or electronically. They usually take around 20 to 30 minutes to fill out.
Hospital visits
You see the doctor to have some tests before taking part in this trial. These tests include:
- a
physical examination , including checking if your spleen or lymph nodes are swollen - blood tests
- pregnancy test – if there is any chance you may be pregnant
- heart tests, such as an
ECG - taking your
blood pressure
You might have 2 extra clinic visits to make sure all the tests are done.
The other hospital visits fit into your usual care. This means you see the team every 3 months for a check up and blood tests. You fill in your questionnaires at these appointments if you are in the randomised part of the trial.
If ibrutinib is no longer working for you, your hospital doctor will let you know of other treatment options. You stop taking ibrutinib.
You see the trial team every year for 3 years or until the trial ends. You are asked to continue to fill in the questionnaires if you were doing so.
Side effects
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 ibrutinib are:
- a drop in blood cells causing an increased risk of infection, bruising and bleeding
- increase in
lymphocytes in the bloodstream - inflammation to the tissue of the lungs (pneumonia)
- high blood pressure (hypertension)
- upper respiratory tract infection (common cold)
- diarrhoea or constipation
- feeling or being sick
- swelling of the hands and feet
- skin rash
- high temperatures (fever)
- dizziness
- painful joints, muscles or bone pain
- muscle spasms
- headache
- sore mouth
- skin infection
- high level of
uric acid in the blood - heavy bleeding (haemorrhage)
- problems with kidney function
We have more information about ibrutinib.
Location
Recruitment start:
Recruitment end:
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.
Chief Investigator
Dr Talha Munir
Supported by
University of Leeds
University of Leeds Clinical Trials Research Unit
National Institute of Health Research (NIHR) Health Technology Assessment (HTA) Programme
Janssen Pharmaceutica NV
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
