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.

Cancer type:

High grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 3

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 remission Open a glossary item ). 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

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 vaccine in 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

Trial design

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).

GOYA trial diagram

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.

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
Lymph node biopsy - if needed
Bone marrow test
CT scan
PET scan – if this available at your hospital
Heart trace (ECG )
Heart scan (ECHO or MUGA )
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.

Side effects

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
Headache
Sore throat, cough or shortness of breath
Runny nose
Irregular heart rate
Pain in your lymph nodes
Feeling or being sick
Diarrhoea
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

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.