“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial looking at GA101 with chemotherapy for low grade non Hodgkin lymphoma
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Doctors often use chemotherapy and a drug called rituximab. This treatment works well for many people, but the lymphoma often comes back and you need to have more treatment. Researchers are looking for ways to improve the first treatment and in this trial they are looking at a new drug called GA101.
GA101 is a monoclonal antibody. It works in a similar way to rituximab. People taking part in this trial have chemotherapy and either GA101 or rituximab. If there is then no sign of their lymphoma (they are in remission), they can carry on having GA101 or rituximab for 2 years. This is called maintenance treatment and aims to stop the lymphoma coming back.
The aims of the study are to
- Find out if GA101 is better at getting low grade NHL into remission than rituximab and if so, whether the remission lasts longer
- Compare the side effects of the 2 drugs
Who can enter
You may be able to enter this trial if you
- Have low grade non Hodgkin lymphoma affecting your B cells and you need to have treatment
- Have a protein called CD20 on the surface of your lymphoma cells
- Have satisfactory blood test results
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are willing to use reliable contraception during the trial for at least 3 months after finishing treatment if there is any chance you or your partner could become pregnant – the trial doctors will give you more information about this
- Are at least 18 years old
You cannot enter this trial if you
- Have had a bad reaction to a monoclonal antibody in the past or are known to be very sensitive to a drug called mannitol or any of the drugs in this trial
- Have lymphoma that has spread to your brain or spinal cord (your central nervous system)
- Have diffuse large B cell lymphoma or lymphoma that started in the covering of the brain and spinal cord (leptomeningeal lymphoma)
- Have lymphoma that has changed (transformed) into a high grade lymphoma
- Have very early stage lymphoma (stage 1)
- Have follicular lymphoma that is grade 3B
- Have had chemotherapy, radiotherapy or
immunotherapyfor follicular lymphoma (if you have another type of lymphoma, you may be able to take part if you’ve had radiotherapy)
- Have had steroids in the last 4 weeks unless you take them for something other than treating your lymphoma and the dose is low
- Have had another type of cancer apart from carcinoma in situ of the cervix or non melanoma skin cancer that has been successfully treated or any other cancer that was successfully treated with surgery at least 5 years ago and has not needed any further treatment
- Have had a serious infection in the last 4 weeks
- Have had a heart attack in the last 6 months or have any other medical condition that the trial doctors think could affect you taking part in this trial
- Have had a
live vaccinein the last 4 weeks
- Have had major surgery in the last 4 weeks (apart from surgery to diagnose your lymphoma)
- Have had an experimental drug as part of another clinical trial in the last 4 weeks
- Are known to be hepatitis B, hepatitis C, HIV or HTLV 1 positive
- Are pregnant or breastfeeding
This is a phase 3 trial. It will recruit about 1,400 people in different countries around the world.
Everybody taking part has chemotherapy to try to get their lymphoma into remission. This is called induction treatment. The type of chemotherapy will vary depending on where you have your treatment. You may have either
- Cyclophosphamide, vincristine and prednisolone (CVP)
- Cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP)
During induction treatment, you also have GA101 or rituximab. The trial is randomised so the monoclonal antibody you have is decided by computer. Neither you nor your doctor will be able to decide which group you are in.
You have either GA101 or rituximab through a drip into a vein at the beginning of each cycle of chemotherapy. People having GA101 have 2 extra doses in the first cycle of treatment.
Induction chemotherapy takes about 6 months all together. The trial doctors will give you more information about exactly how and when you have the drugs.
The trial team will ask you to fill out a questionnaire before you start treatment, half way through and at the end of your induction treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
A few weeks after you finish your induction treatment, you have tests and scans to see if all signs of your lymphoma have disappeared.
If there is no sign of your lymphoma (remission), you then have maintenance treatment. If you are in the rituximab group, you have rituximab once every 2 months for up to 2 years. If you are in the GA101 group, you have GA101 once every 2 months for up to 2 years.
If there are still signs of your lymphoma, but it has not got worse, the trial doctors will continue to monitor you. They call this observation.
If your lymphoma has got worse or if it gets worse during maintenance or observation, you leave the study and the trial doctors will talk to you about having other treatment.
You see the trial doctors and have some tests before you start treatment. The tests include
You may also have a PET scan.
The trial team will get a sample of your lymphoma that was taken when you had a biopsy to diagnose your disease.
The number of hospital visits you have during induction treatment will depend on the drugs you have. You should be able to have your treatment as an outpatient. You have regular blood tests and a CT scan half way through. You may need to have another biopsy.
About 6 to 8 weeks after you finish the induction treatment, you have blood tests and a CT scan. If you had a PET scan before your treatment, you may have another one at this point. You may also need to have a bone marrow test. If you don’t need a bone marrow test, the trial team will ask you to have one to donate some bone marrow for research. But this is optional. You don’t have to give this sample of bone marrow if you don’t want to.
If you have maintenance treatment, you go to hospital to see the doctors and have treatment once every 2 months for up to 2 years. You also have to go for blood tests a couple of days before each treatment.
If you have observation, you see the doctors and have blood tests every 2 months.
If your lymphoma stays in remission or doesn’t get any worse, the trial team will continue to monitor you after the 2 years of maintenance or observation. You will see them every 3 months for the next 3 years and then every 6 months for 2 years after that. You have a CT scan every 6 months for the first 3 years and then once a year for the next 2 years.
If your lymphoma comes back or gets worse during this time, you will leave the study and have other treatment. The trial team will contact you twice a year to see how you are.
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 white blood cells causing an increased risk of infection
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
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.
Dr Robert Marcus
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)