A trial looking at ibrutinib with obinutuzumab for chronic lymphocytic leukaemia (IcICLLe Extension)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at the combination of ibrutinib with obinutuzumab to treat chronic lymphocytic leukaemia (CLL). The trial is an extension of the IcICLLe trial.
More about this trial
If you have been diagnosed with chronic lymphocytic leukaemia (CLL) and have symptoms, you may have treatment such as chemotherapy. But researchers are looking for new ways to treat CLL.
Ibrutinib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. We know from research that ibrutinib can help people with CLL. But the researchers need to know more about how it works.
Obinutuzumab (OH bi nue TOOZ ue mab) is another type of biological therapy called a monoclonal antibody. It works by targeting a certain protein on the leukaemia cells.
Researchers think that the combination of ibrutinib and obinutuzumab may work well for people with CLL.
Some people who are already taking ibrutinib as part of the IcICLLe trial will be asked if they want to join this trial.
People who have CLL that has continued to get worse during treatment (refractory) or that has come back after treatment (relapse) and who haven’t taken part in the IcICLLe trial will also be asked to join.
Everyone who takes part will have ibrutinib and obinutuzumab.
The main aims of this study are to find
- How well ibrutinib and obinutuzumab works for people with CLL
- What the side effects are
Who can enter
The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.
You may be able to join this trial if all of the following apply. You
- Have chronic lymphocytic leukaemia (CLL) that needs treatment
- Have CLL that has come back after treatment (relapsed) or continued to get worse during treatment (refractory)
- 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 at least 18 years old
If you are taking part in the IcICLLe trial because your CLL was refractory or relapsed and you have had at least 6 months of ibrutinib you can join the extension trial.
You cannot join this trial if any of these apply
- Your leukaemia has spread to your brain or spinal cord
- Your CLL has changed into another type of leukaemia
- You have prolymphocytic leukaemia
- You have mantle cell lymphoma
- You have HIV, hepatitis B or hepatitis C
- You have another cancer apart from
basal cell skin cancer 
- You need blood transfusions because you have a low number of red blood cells, unless this was caused by your CLL
- Your red blood cells are breaking down abnormally and this isn’t being controlled with a low dose of steroids
- You have had blood thinning drugs, such as warfarin, in the past week
- You are taking medication that affects body substances called CYP enzymes
- You have certain heart problems
- You have had major surgery in the past month
- You have had damage to your brain due to a lack of blood supply (stroke) in the past 6 months
- You have had a bleed inside your skull in the past 6 months
- You have had a live vaccine in the 28 days before joining this trial
- You are allergic to obinutuzumab or its ingredients
- You have already had ibrutinib unless you are having it as part of IcICLLe trial
- You have had another drug that works in a similar way to ibrutinib
- You have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- You are pregnant or breastfeeding
Trial design
This is a feasibility study. The researchers need 40 people to join. Everyone taking part will have ibrutinib and obinutuzumab.
If you are taking part in the IcICLLe trial you may be asked to join this extension trial. You don’t have to and you can continue taking ibrutinib as part of the IcICLLe trial.
Ibrutinib is a capsule you take every day. You start by taking 3 capsules once a day. Your doctor will tell you if your dose needs to change. You take the capsules with a glass of water ½ hour before food or 2 hours after food.
If you haven’t taken ibrutinib before you need to take it at least 24 hours before you start obinutuzumab.
You have obinutuzumab as a drip into a vein. You start with a small part of the dose to reduce the risk of having a reaction. If you don’t have a reaction or have a very mild reaction you may be able to have the rest of it on the same day. Otherwise you will get the remainder the next day.
You then have obinutuzumab once a week for the next 2 weeks and then once a month. Each treatment of obinutuzumab will take about 4 hours depending on how well you feel when you are having the treatment.
As long as it is helping and the side effects aren’t too bad you can have 9 doses of obinutuzumab.
You continue taking ibrutinib as long as it is helping you and the side effects aren’t too bad.
During the trial the researchers will take some extra blood samples from you. This is to find out how well your CLL responds to treatment.
You will also have extra bone marrow tests. If you are new to the IcICLLe Extension trial this will be a maximum of 4. If you were previously in the IcICLLe trial it will be a maximum of 3. They will use these to better understand how the treatment works. You must agree to these tests to take part in this trial.
Hospital visits
You see the doctor to have some tests before taking part. These tests include
- A physical examination
- Blood tests
- CT scan
- Heart trace (
ECG ) - Bone marrow test
People coming over from the IcICLLe trial may not need to have all the above tests done. Your doctor will let you know.
You may need to have your 1st treatment of obinutuzumab over 2 days. This is to reduce any reaction you might have.
During the 1st month you have your treatment frequently so you may see the doctor up to 6 times. After this you then have treatment once a month for 4 months.
You will have a physical examination and blood tests at some of these visits. You have a heart trace after the first month. You have a CT scan at 3 months and depending on the results you may have another one at 6 months.
After finishing treatment with obinutuzumab you see the doctor every 6 months for a physical examination and blood tests.
Side effects
The most common side effects of ibrutinib include
- Diarrhoea or constipation
- Tiredness
- Feeling or being sick
- Infection
- Cough
- Swelling of the hands or feet
- Skin rash
- High temperature (fever)
- Dizziness
- Joint aches
- Headache
- Sore muscles or muscle cramps
- Shortness of breath
- Tummy (stomach) pain
- Loss of appetite
- Heartburn or indigestion
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
The most common side effects of obinutuzumab include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- A worsening of any existing heart problems
- A reaction while having, or soon after having, obinutuzumab
Your doctor will talk to you about the possible side effects before you agree to take part.
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
Professor Peter Hillmen
Supported by
Bloodwise
NIHR Clinical Research Network: Cancer
Pharmacyclics Inc
Roche
University of Birmingham
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
