A trial of GP2013 alongside chemotherapy for follicular lymphoma

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Low grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 3

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.

Who can enter

You may be able to join this trial if all of the following apply

You have follicular lymphoma in lymph nodes on both sides of your diaphragm or that has spread to another part of your body (stage 3 or 4)
Your lymphoma has the CD20 protein (you can ask your doctor about this)
You have at least 1 area of lymphoma that can be measured on a scan and is bigger than 10mm
You have satisfactory blood test results
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Your heart works well enough (your doctor will test for this)
You are willing to use reliable contraception during treatment and for a year afterwards if there is any chance you or your partner could become pregnant
You are at least 18 years old

You cannot join this trial if any of these apply

You have follicular lymphoma that is fast growing (high grade )
Your lymphoma has transformed from a low grade to a high grade or into diffuse B cell lymphoma
You have lymphoma in your brain or spinal cord
Your lymphoma is pressing against your spinal cord causing spinal cord compression
You have already had treatment for your follicular lymphoma
You have an infection
You have had high dose steroids or are taking steroids long term (your doctor can advise about this)
You have had another cancer in the past 5 years apart from in situ carcinoma of the cervix and non melanoma skin cancer
You have had major surgery in the past month or may need surgery during the trial
You have certain heart conditions (the trial team can advise about this)
You have tested positive for HIV
You have any other serious medical condition or mental health problem that the team think could affect you taking part in this trial
You have had an experimental drug in the past month
You plan to have a live vaccine during the trial or have had a live vaccine in the past month
You are allergic to the drugs used in this trial, or their ingredients
You are pregnant or breastfeeding

Trial design

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.

People in group1 have GP2013 alongside cyclophosphamide, vincristine and prednisolone (CVP)
People in group 2 have rituximab alongside CVP

12289 Trial Diagram

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.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

A physical examination
Blood tests
Urine test
Heart trace (ECG )
Heart scan (ECHO or MUGA )
CT scan or MRI scan
Bone marrow test (if needed)

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