Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of ibrutinib with rituximab for chronic lymphocytic leukaemia (FLAIR)
This trial is comparing a drug called ibrutinib alongside rituximab with fludarabine, cyclophosphamide and rituximab for chronic lymphocytic leukaemia. This trial is for people who haven’t yet had treatment for their chronic lymphocytic leukaemia (CLL). This trial is supported by Cancer Research UK.
Doctors often treat chronic lymphocytic leukaemia (CLL) with the drugs fludarabine, cyclophosphamide and rituximab (FCR). Fludarabine and cyclophosphamide are chemotherapy. Rituximab is a biological therapy called a monoclonal antibody. It seeks out cancer cells by looking for particular proteins. This combination of drugs works but researchers are always looking for ways to improve treatment.
Ibrutinib is a biological therapy called a cancer growth blocker. It stops signals that cancer cells use to divide and grow. We know from research that ibrutinib has helped people whose CLL had continued to grow during treatment or had come back after treatment.
The researchers think that ibrutinib with rituximab might work well for people with CLL who haven’t yet had treatment. To find this out they want to compare ibrutinib and rituximab with fludarabine, cyclophosphamide and rituximab (FCR).
The aims of this trial are to find out
- If ibrutinib with rituximab is better than FCR to treat people with chronic lymphocytic leukaemia
- How safe the combination of ibrutinib and rituximab is
- The side effects of having ibrutinib with rituximab
Who can enter
You may be able to join this trial if you have at least one of the following symptoms
- Without meaning to, you have lost 10% or more of your body weight in the past 6 months
- You are very tired and this affects your daily activities
- You have had a fever for 2 weeks or more but have no sign of an infection
- You have had
night sweatsfor more than a month and have no sign of an infection
You must also
- Have chronic lymphocytic leukaemia (CLL) that needs treating
- Be fit enough to have treatment with fludarabine, cyclophosphamide and rituximab (FCR)
- Be well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood test results
- Be able to swallow tablets or capsules
- Be willing to use reliable contraception during treatment and for a year afterwards if there is any chance you or your partner could become pregnant
- Be between 18 and 75 years old
You cannot join this trial if any of these apply
- You have already had treatment for your leukaemia
- Your leukaemia has transformed into Richter’s syndrome
- You have leukaemia in your brain or spinal cord
- You are to have major surgery within 4 weeks of taking part in this trial
- You have an infection
- At least 1 in 5 (20%) of your leukaemia cells have a faulty or missing p53 gene (your doctor can tell you this)
- You have serious problems with your heart, breathing or
digestive system(the trial team can advise you about this)
- You have got HIV, hepatitis B or hepatitis C
- You have had another cancer in the past 3 years apart from successfully treated non melanoma skin cancer and carcinoma in situ of the cervix
- You have had a stroke in the past 6 months
- You take other medication that affects body substances called CYP enzymes (your doctor can advise you about this)
- You are taking medication to thin your blood, such as warfarin
- You have any other medical condition or mental health problem that the trial team think could affect you taking part
- You are pregnant or breastfeeding
This is a phase 3 trial. The researchers need 754 people to join.
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 ibrutinib and rituximab
- People in group 2 have fludarabine, cyclophosphamide and rituximab (FCR)
Ibrutinib is a capsule. You take 3 capsules every day for up to 6 years. You might stop and restart treatment during the 6 years. This depends on how your CLL responds. Your doctor will talk to you about this.
You have rituximab as a drip into a vein. You have it every 4 weeks. Each 4 week period is called a cycle of treatment. You have 6 cycles of rituximab.
If you are having FCR, you have rituximab as above. You can have fludarabine and cyclophosphamide as tablets or as a drip into a vein. Your doctor will talk to you about what is the best way for you to have them. You have 6 cycles of FCR.
The trial team will ask you to fill out a questionnaire before you start treatment, after you finish rituximab or FCR and then every 6 months for another 6 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 for blood samples before you start treatment, 3 months after your last rituximab treatment and 3 months after that. Then you will have blood tests every 6 months if you had ibrutinib, or every year if you had FCR, for another 6 years.
They will also ask for a
You see the doctor to have some tests before taking part in this trial. These tests include
During treatment you see the doctor every 4 weeks for a physical examination and blood tests.
Three months after your last rituximab treatment you see the doctor for the same tests you had at the start, apart from the heart trace. You continue to see the doctor every 6 months for another 6 years. At these appointments, you have a physical examination and blood tests.
The most common side effects of ibrutinib are
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Diarrhoea or constipation
- Feeling or being sick
- Swelling of your hands and feet
- Skin rash
- High temperatures (fever)
- Painful joints and muscles
- Shortness of breath
- Tummy (abdominal) pain
- Loss of appetite
We have information about the side effects of FCR.
Your doctor will talk to you about the possible side effects of treatment before you agree to take part in the trial.
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.
Professor Peter Hillmen
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
University of Leeds
This is Cancer Research UK trial number CRUK/12/037.