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

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

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

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.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Martin Dyer

Supported by

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

Last review date

CRUK internal database number:

Oracle 9357

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

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