
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
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 GP2103 alongside chemotherapy to treat follicular lymphoma.
Doctors usually treat follicular lymphoma with chemotherapy and a monoclonal antibody. The chemotherapy they usually use is a combination of cyclophosphamide, vincristine and prednisolone (CVP). The monoclonal antibody they use is rituximab (Mabthera).
GP2013 is a monoclonal antibody that is similar, but not identical, to rituximab.
The researchers want to compare rituximab alongside CVP with GP2013 alongside CVP. The aim of the trial is to find out if GP2013 works as well rituximab to treat follicular lymphoma.
You may be able to join this trial if all of the following apply
You cannot join this trial if any of these apply
This is an international phase 3 trial. The researchers need 618 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. And neither of you will know which group you are in. This is called a double blind trial.
You have GP2013 or rituximab alongside cyclophosphamide and vincristine as injections into a vein. You have them every 3 weeks. Each 3 week period is called a cycle of treatment. Prednisolone is a tablet you take for the first 5 days of each cycle of treatment. You have 8 cycles of treatment.
After the 8 cycles, you continue having GP2013 or rituximab for 2 years as long as it is helping you and the side effects aren’t too bad.
If you agree to take part in this study, the researchers may ask for extra blood samples and bone marrow tests during treatment. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.
You see the doctor to have some tests before taking part in this trial. These tests include
During the first 8 cycles of treatment you see the doctor every 3 weeks for a physical examination and blood tests. For the next 2 years you see the doctor every 3 months for
After treatment you see the doctor every 3 months for up to 2 years.
GP2013 is similar to rituximab and the researchers expect the side effects to be the same. The most common side effects of rituximab are
Rituximab can also cause flu like symptoms, night sweats and a drop in blood pressure.
The most common side effects of CVP are
Your doctor will talk to you about the possible side effects of treatment before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Edward Kanfer
Hexal AG
Novartis
Sandoz
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.