
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
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 ibrutinib alongside chemotherapy and rituximab for low grade lymphoma that has got worse or come back despite having other treatment.
Certain types of non Hodgkin lymphoma are slow growing. They are called low grade or indolent lymphoma.
Doctors can treat low grade lymphoma with chemotherapy. You may also have rituximab, which is a type of drug called a monoclonal antibody.
If your lymphoma comes back, you will need to have more treatment. The treatment you have at this time will depend on the first treatment you had. But you may have a combination of chemotherapy and rituximab. In this trial, researchers want to see if adding another drug called ibrutinib helps people in this situation.
Ibrutinib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
Everybody taking part in the trial has chemotherapy (either bendamustine or CHOP) and rituximab. The type of chemotherapy you have will depend on which treatment you’ve had in the past. Some people will also have ibrutinib, some will have a dummy drug ().
The aim of the trial is to see if adding ibrutinib to chemotherapy and rituximab helps people with low grade lymphoma that has come back despite having other treatment.
You may be able to join this trial if all of the following apply. You
You cannot join this trial if any of these apply. You
This is an international phase 3 trial. The researchers need about 400 people to take part.
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. And neither of you will know which group you are in. This is called a double blind trial.
Everybody taking part has chemotherapy (either bendamustine or CHOP) and rituximab. The type of chemotherapy you have in the trial will depend on which treatment you’ve had in the past.
Half the people taking part will also have ibrutinib. The other half will have a dummy drug ().
If you have bendamustine chemotherapy, you have it through a drip into a vein on 2 days every 4 weeks. Each 4 week period is called a cycle of treatment. You have rituximab through a drip into a vein on the first day of each cycle of treatment.
If you have CHOP chemotherapy, a cycle of treatment takes 3 weeks. You have the drugs cyclophosphamide, doxorubicin and vincristine through a drip into a vein every 3 weeks. You also take prednisolone tablets for 5 days. You have rituximab through a drip into a vein on the first day of each treatment cycle.
Whichever type of chemotherapy you have, as long as you don’t have bad side effects, you can have up to 6 cycles of treatment.
Ibrutinib (or the dummy drug) comes in capsules that you swallow. You take 4 capsules once every day. You continue taking ibrutinib (or the dummy capsules) on their own after you finish your chemotherapy. You can carry on taking them until your lymphoma starts to get worse.
The trial team will ask you to fill out a questionnaire at the beginning of the 1st and 6th treatment cycles, and then every 6 months. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
They will also ask you to keep a diary card at home. In this, you write down when you take your capsules. You must take the diary to each hospital appointment.
You see the trial team and have some tests before you start treatment. The tests include
You may also need to have an MRI scan.
How often you go to hospital for treatment will depend on the type of chemotherapy you are having. When you have finished your chemotherapy but are still taking the capsules, you go to hospital once every 8 weeks.
You have regular blood tests during treatment. You may need to have more ECGs. You have a CT scan after 3 months, 6 months and then every 4 months for up to 3 years. After 3 years, you have a CT scan every 6 months until your lymphoma starts to get worse or the study has completely finished.
You will have another PET scan if your doctor thinks your lymphoma has completely disappeared.
When you finish treatment, you see the trial team again within a month. They will then check how you are every 3 months for 3 years and then every 6 months after that. This may be at hospital appointments, or they may contact you by phone.
As ibrutinib is a new drug, there may be side effects we don’t know about yet. In trials so far, the most common side effects have been
We have more information about the side effects of
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Simon Rule
Janssen-Cilag
NIHR Clinical Research Network: Cancer
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”