Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial looking at brentuximab for people with Hodgkin lymphoma who are unable to have chemotherapy (BREVITY)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called brentuximab for people with Hodgkin lymphoma who are too unwell to have chemotherapy. Brentuximab is also known as Adcetris or SGN-35.
Doctors usually use chemotherapy to treat Hodgkin lymphoma (HL). But some people are too unwell to have this type of treatment, or have another medical condition which means they cannot have chemotherapy.
Brentuximab is a type of biological therapy called a monoclonal antibody. These can seek out cancer cells by looking for particular proteins. Brentuximab sticks to a protein called CD30 found on the surface of certain lymphoma cells. Brentuximab then delivers a drug to the cell, killing that cell.
Researchers know that Brentuximab has been helpful for people whose HL has come back after chemotherapy treatment. So they think this drug may help people who can’t have chemotherapy. They also think it may have fewer side effects.
The aims of this trial are to find out
- Whether Brentuimab works as a first treatment for HL
- More about the side effects
Who can enter
You may be able to join this trial if you have 1 of the following
- Hodgkin lymphoma in 2 or more groups of lymph nodes, or a body organ and 1 or more groups of lymph nodes, if all are on the same side of your
diaphragm. This is stage 2 Hodgkin lymphoma
- Hodgkin lymphoma that is on both sides of your diaphragm (stage 3)
- Hodgkin lymphoma that is in many groups of lymph nodes, and has spread to body organs such as the liver, bones or lungs (Stage 4)
If you have stage 2 lymphoma, you must have all of the following
- Symptoms such as sweating at night, a high temperature that comes and goes, or unexplained weight loss (B symptoms)
- Lymphoma outside your lymphatic system
- A lymph node that is bigger than 10cm, or lymphoma in the centre of your chest
- More than 3 lymph nodes affected, or if fewer than 3 lymph nodes are affected, you can’t have radiotherapy
As well as meeting the conditions for the stage of lymphoma, all of the following must apply. You
- Have classical type Hodgkin lymphoma that has tested positive to a protein called CD30 (the trial team will test for this)
- Haven’t had any treatment for your Hodgkin lymphoma so far
- Are unable to have chemotherapy for medical reasons
- Have lymphoma that can be seen on a PET scan and at least one area of cancer measures at least 1½ cm across
- Have satisfactory blood test results
- Are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance that you or your partner could become pregnant
- Are at least 16 years old. If you are over 60, you must be well enough to be up and about for at least some of each day, even if you need help looking after yourself (performance status 0, 1, 2 or 3)
You cannot join this trial if any of these apply. You
- Have a type of lymphoma called nodular lymphocyte predominant Hodgkin lymphoma
- Have lymphoma that has spread to your brain
- Have had any other cancer in the last 2 years, unless it was a very early stage and has been successfully treated (the trial team can advise you about this)
- Have had treatment in a trial in the last 6 weeks
- Are known to be HIV, hepatitis B or hepatitis C positive
- Are allergic to the drug used in this trial, anything it contains, or to similar drugs
- Have any other medical condition that the trial doctor thinks could affect your taking part
This is a phase 2 trial. The researchers need between 20 to 30 people to join the trial.
You have brentuximab through a drip into a vein. This takes about 30 minutes and you have it every 3 weeks.
If a scan after 3 months shows that your lymphoma has responded to treatment, you can continue treatment for another 9 months.
If the treatment is not working after 3 months, or your lymphoma comes back at any time you will stop treatment on this trial. You doctor will discuss other treatment options with you.
You will see the doctors and have some tests before you start treatment. The tests include
If you have chest problems or difficulty breathing you may have tests to find out how well your lungs are working (
If you have had some of these tests quite recently when you were diagnosed with HL, you may not need to have them again before you start treatment in this trial.
The trial team will ask your doctor for a sample of your cancer that was removed when you were diagnosed with HL. They use this sample to test your cancer to see if it has a protein called CD30.
You go to hospital every 3 weeks for treatment. You have an extra visit to hospital 2 weeks after your first treatment. You see a doctor who will examine you, ask about any side effects you are having and take blood for tests.
You have a PET scan after 6 weeks, then a PET scan and a CT scan after 3 months. You may also have a bone marrow test after 3 months if you had HL in your bone marrow when you were diagnosed.
If you continue with the treatment for longer than 3 months, you have a CT scan every 3 months.
After you finish treatment you visit hospital to have blood tests and a CT scan. You may have another bone marrow test. As long as there is no sign of your lymphoma, you go to hospital every 3 months for 2 years.
If the treatment did not work, or your lymphoma comes back at any time you do not need to have extra visits as part of this trial. The trial team will collect information about your health during your normal visits to see your doctor.
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 John Radford
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham