
"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 new drug called GA101 for people who have diffuse large B cell lymphoma (DLBCL) who haven’t been treated previously.
Doctors often treat this type of lymphoma with a combination of drugs called R-CHOP. This includes the chemotherapy drugs cyclophosphamide, doxorubicin, vincristine, prednisolone and a biological therapy called rituximab. For many people, it gets rid of the lymphoma cells (gets it into ). Doctors are always looking for ways to improve the number of people whose lymphoma goes into remission.
GA101 is a monoclonal antibody. It works in a similar way to rituximab. People taking part in this trial have CHOP with GA101 (G-CHOP) or with rituximab (R-CHOP).
The researchers want to compare G-CHOP with R-CHOP to find out
You may be able to enter this trial if
You cannot enter this trial if you
This is an international phase 3 trial. It will recruit 1,400 people from different countries around the world. 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 will have cyclophosphamide, doxorubicin, vincristine, prednisolone and rituximab (R-CHOP).
People in group 2 will have cyclophosphamide, doxorubicin, vincristine, prednisolone and GA101 (G-CHOP).
You have cyclophosphamide, doxorubicin, vincristine, rituximab or GA101 as injections into a vein every 3 weeks. Each 3 week period is called a cycle of treatment. Prednisolone is a tablet. You take it for the first week of each cycle.
People having GA101 have 2 extra doses in the first cycle of treatment on day 8 and 15 of this cycle.
You have 6 to 8 cycles of treatment. Your doctor will tell you how many cycles you will have before you start treatment.
The trial team will ask you to fill out a questionnaire before you start treatment, during treatment and then every year after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor to have some tests before taking part in this trial. These tests include
During treatment you see the doctor regularly for a physical examination and blood tests. You have a CT scan at 15 weeks.
About 2 months after treatment you see the doctor for the same tests you had at the beginning, apart from the lumbar puncture.
You then see the doctor every 3 months for the first 2 years, every 6 months for the next 2 years and then once more a year after that.
As GA101 is a new drug, there may be some side effects we don’t know about yet. The most common known side effects are fever, chills and flu like symptoms when you have the first dose. Other, less common side effects include
There is a risk that you could have an allergic reaction to GA101. The trial team will monitor you closely during treatment. If necessary, they can stop the GA101 and treat any symptoms
We have information about the side effects of R-CHOP in our cancer drugs section.
Your doctor will talk to you about possible side effects before you agree to take part in this trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Martin Dyer
Experimental Cancer Medicine Centre (ECMC)
Genentech Ltd
Roche
If you have questions about the trial please contact our cancer information nurses
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.”