
"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 for a type of non Hodgkin lymphoma called diffuse large B cell lymphoma (DLBCL). It is for people who have a particular type of DLBCL and who haven’t had any other treatment for their lymphoma.
Diffuse large B cell lymphoma (DLBCL) is a type of non Hodgkin lymphoma. It is the most common type of high grade non Hodgkin lymphoma.
There are different types of DLBCL. The people taking part in this trial have a type called non GCB. Just over half of people diagnosed with DLBCL have this type.
Doctors usually treat DLBCL with a chemotherapy drug combination called CHOP and a monoclonal antibody called rituximab. This treatment is called R-CHOP.
The non GCB type of DLBCL tends to be faster growing than some other types and it may not respond as well to treatment. So researchers are looking for other ways to treat it. In this trial, they are looking at a drug called ibrutinib.
Ibrutinib is a type of biological therapy. Is it a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
The aim of this trial is to see if having ibrutinib alongside R-CHOP helps people who have recently been diagnosed with the non GCB type of diffuse large C cell lymphoma and haven’t had any other treatment yet.
You may be able to enter this trial if
You cannot enter this trial if you
This phase 3 trial will recruit about 800 people in different countries.
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 has the drugs rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone. This is called R-CHOP. Half the people taking part also have ibrutinib. The other half have a dummy drug (a ).
You have 3 week cycles of treatment. On the first day of each treatment cycle you have rituximab, cyclophosphamide, doxorubicin and vincristine through a drip into vein. You take prednisolone tablets on the first 5 days of each treatment cycle.
You take ibrutinib (or the dummy drug) as capsules. You take 4 capsules once every day.
You may have 6 or 8 cycles of treatment. If you stop having R-CHOP because you have bad side effects, but your lymphoma hasn’t got worse, you can carry on taking ibrutinib (or the dummy drug). As long as you don’t have bad side effects, and your lymphoma doesn’t get worse, you can continue taking it until you would have finished your chemotherapy.
The trial team will ask you to fill out a questionnaire before you start treatment, at the beginning of each treatment cycle, when you finish treatment and at follow up appointments for up to 5 years. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
They will also give you a diary card to write down when you take the capsules each day.
You see the trial team and have some tests before you start treatment. The tests include
The trial team will get a sample of your lymphoma that was removed when you had a lymph node biopsy in the past. If there is not a sample available, they may ask you to have another lymph node biopsy.
You go to hospital for treatment every 3 weeks. You have weekly blood tests.
You have a CT scan after 4 cycles of treatment. The trial team may ask you to have another lymph node biopsy if your lymphoma starts to get worse.
When you finish treatment, you have a CT scan and a PET scan about 3 weeks later. You may have another bone marrow test. You see the trial team about a month after you finish treatment.
After that, you have a CT scan and see the trial team
As ibrutinib is a new drug, there may be side effects we don’t know about yet. In other trials, the most common side effects have been
Other side effects have been
The most common side effects of R-CHOP include
The trial team will give you more information about all the possible side effects of the different drugs before you agree to take part in the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Peter Johnson
Experimental Cancer Medicine Centre (ECMC)
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.”