“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial of rituximab as an injection under the skin for diffuse large B cell lymphoma (MABEASE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing different ways of having a drug called rituximab alongside chemotherapy as the first treatment for diffuse large B cell lymphoma.
Rituximab is a type of biological therapy called a monoclonal antibody. It targets a protein called CD20 on lymphoma cells. The antibody sticks to the CD20 protein. Then the cells of the immune system pick out the marked cells and kill them.
You usually have rituximab through a drip into a vein. In this trial, researchers are looking at giving rituximab as an injection just under the skin (subcutaneous injection).
The aim of the trial is to compare standard rituximab through a drip into a vein with subcutaneous rituximab, alongside CHOP chemotherapy for diffuse large B cell lymphoma.
Who can enter
You may be able to enter this trial if you
- Are between 18 and 80 years of age
- Have diffuse large B cell lymphoma and your lymphoma cells make the CD20 protein (they are CD20 positive)
- Have at least 1 area of lymphoma that can be seen on a scan and measures at least 1.5cm across
- 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 and for a year afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have lymphoma that has spread to your brain or spinal cord
- Have lymphoma that has changed (transformed) into Burkitt’s lymphoma
- Have lymphoma that started in the centre of your chest (the mediastinum), your skin, your testicles, or in body cavities such as the area around your heart (pericardium) or between the 2 sheets that cover your lungs (the pleura)
- Have lymphoma that has changed from low grade to high grade or follicular lymphoma that is grade 3B
- Have had any other treatment for lymphoma apart from radiotherapy to a small area of your body or a lymph node biopsy
- Have already had chemotherapy or rituximab for another medical condition
- Have ever had a monoclonal antibody that targets CD20
- Have had major surgery in the last 4 weeks
- Have had a bad reaction to similar drug to rituximab (a monoclonal antibody) or are known to be very sensitive to anything made in a similar way
- Have already had an
anthracycline drugor can’t have any of the drugs in CHOP chemotherapy
- Have had another type of monoclonal antibody in the last 3 months
steroidsunless is a low dose and the dose hasn’t changed in the last 4 weeks – the trial team can advise you about this
- Have had another experimental drug in the last 4 weeks
- Have had another type of cancer in the last 5 years apart from skin cancer or carcinoma in situ of the cervix that was successfully treated
- Have problems with your liver or kidneys
- Are known to be HIV positive
- Have had a serious infection that needed hospital treatment in the last 4 weeks
- Have an active hepatitis B or hepatitis C infection (you may be able to take part if you carry the hepatitis B or C virus but don’t have an active infection)
- Have any other medical condition that the trial team think could affect you taking part
- Are pregnant or breastfeeding
This phase 3 trial will recruit about 600 people. 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.
Everybody taking part has CHOP chemotherapy and rituximab. You can have CHOP in 2 or 3 week cycles. The trial team will explain how often you will have treatment and how many cycles they plan for you to have.
As long as you don’t have bad side effects and your lymphoma doesn’t get worse, you have rituximab 8 times. Everybody has the first dose of rituximab through a drip into a vein. From then on, 2 out of every 3 people taking part have rituximab as an injection under the skin (a subcutaneous injection) and the remaining 1 in 3 carry on having rituximab through a drip into a vein.
The trial team will ask you to fill out questionnaires when you have your 3rd and 7th doses of rituximab. The questionnaires will ask what you think about your rituximab treatment.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- CT scan or PET-CT scan
- Heart trace (
- Bone marrow test (if you haven’t already had one)
You go to hospital every 2 or 3 weeks depending on your treatment plan. You have regular blood tests.
After the 4th cycle of treatment, you have another CT or PET-CT scan. If the scan shows that your lymphoma hasn’t got any better, or has got worse, you will stop the trial treatment. Your doctor will talk to you about other treatment options.
If the scan shows that your lymphoma has completely gone and you were due to have 4 more cycles of treatment, this may be changed to just 2 more cycles of R-CHOP, followed by 2 doses of rituximab on its own.
When you finish treatment, you see the trial team again within a month. You have a physical examination, blood tests and a CT or PET-CT scan. If these tests show that your lymphoma has completely gone, you may need to have another bone marrow test to check this.
You see the trial team every 3 months for 2 years and then every 6 months until the trial has completely finished. You have blood tests each time. You may have scans each time until your lymphoma starts to get worse.
If you didn’t have all 8 doses of rituximab for any reason, you see the trial team just once more, within a month of stopping treatment. The trial team will continue to check how you are and see if you’re having any other treatment until the trial has completely finished. But they can do this by phone.
Some people have a reaction to rituximab when they have it through a drip into a vein. This can cause problems such as
- High temperature (fever) and chills
- Feeling or being sick
- Tiredness (fatigue)
- Skin rash or redness
- Wheezing or tightness in the chest
- Shortness of breath or difficulty breathing
- Swelling of the throat or tongue
- Runny nose
- A drop in blood pressure
- Fast heart rate
- Chest pain
If you have subcutaneous rituximab, you may be less likely to have these side effects.
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 Andrew Hodson
National Institute for Health Research Cancer Research Network (NCRN)