"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at GA101 for diffuse large B cell lymphoma (GOYA)
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
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
- If diffuse large B cell lymphoma is more likely to go into remission with GA101 than with rituximab
- If remission lasts longer using GA101 than rituximab
- What the side effects of GA101 are like compared to rituximab
Who can enter
You may be able to enter this trial if
- You have diffuse large B cell lymphoma with cells that carry a protein called CD20
- Your lymphoma hasn’t been treated
- You have at least 1 area of lymphoma that is bigger than 1½ cm and can be seen on a CT scan
- Your heart works well enough – your doctor will test for this
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You have satisfactory blood test results
- 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 enter this trial if you
- Have already had treatment for lymphoma, apart from surgery to remove a lymph node or radiotherapy to an area of lymphoma
- Have lymphoma that has changed from a slow growing lymphoma to diffuse large B cell lymphoma
- Have follicular lymphoma that is fast growing (grade 3B)
- Have lymphoma in your brain or spinal cord
- Have been vaccinated with a
live vaccinein the last month
- Have had treatment as part of a clinical trial in the last month
- Have had another cancer apart from successfully treated non melanoma skin cancer or in situ carcinoma of the cervix or any other cancer that was removed with surgery to try and cure it and there hasn’t been any sign of it for the last 5 years
- Are taking 30mg, or more, of prednisone a day – you may be able to take part if you are taking it for symptom control of your lymphoma and the dose has been the same for the last month
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
- A physical examination
- Blood tests
- Urine test
- Lymph node biopsy - if needed
- Bone marrow test
- CT scan
- PET scan – if this available at your hospital
- Heart trace (
- Heart scan (
- Lumbar puncture
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
- Skin rash, blisters or itching
- A feeling of swelling in your mouth or throat
- Changes in your blood pressure
- Hot flushes
- Sore throat, cough or shortness of breath
- Runny nose
- Irregular heart rate
- Pain in your lymph nodes
- Feeling or being sick
- A drop in blood cells causing an increased risk of infection, bruising or bleeding
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
Your doctor will talk to you about possible side effects before you agree to take part in this trial.
How to join a clinical 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)