Purpose of trial
The aim of the trial is to compare treatment with the combination of rituximab and bendamustine chemotherapy against the combination of rituximab and bendamustine with added brentuximab. The trial is for people with:
- the most common type of high grade lymphoma, called diffuse large B cell lymphoma (DLBCL)
- a fast growing type of follicular lymphoma – grade 3b.
DLBCL is a fast growing lymphoma that is usually treated with chemotherapy and antibody therapy.
It often responds well to treatment and in many people the disease is brought under control (into remission). However, some cases of DLBCL do not respond so well to treatment, particularly when the lymphoma is advanced.
Most follicular lymphomas are slow growing. Grade 3b follicular lymphoma is usually treated like DLBCL as it is fast growing.
This is a randomised trial with 2 treatment groups. Participants are randomised to receive rituximab and bendamustine with or without brentuximab. You can’t choose which treatment you have and neither can your doctor. You are told which treatment you are having and given information about it.
Everyone in the trial has rituximab and bendamustine. You have these drugs intravenously (through a drip into a vein). You will have one on the first day and the other on the second day of every 3 week cycle of treatment. In a cycle of treatment, you have the drugs on some days followed by a rest period to allow your body to recover before the next cycle.
If you are in the group having brentuximab, you have the same treatment as above but have brentuximab intravenously before the other drugs on both days.
Both groups have up to 6 cycles of treatment. If you are in the brentuximab group and you do not have troublesome side effects, you may have up to 10 more cycles with brentuximab alone.
Bendamustine is a chemotherapy drug. Rituximab and brentuximab are both antibody treatments. They target proteins (antigens) called CD20 and CD30, respectively, which are found on DLCBL and follicular lymphoma cells. Once the antibody has found the antigen, it attaches (binds) to it, which kills the lymphoma cells.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
110 people are needed for this trial.
You may be able to enter if:
- You have diffuse large B cell lymphoma or follicular lymphoma that has tested positive for CD30.
- Your follicular lymphoma is grade 3b .
- You have previously had at least 2 courses of treatment and you have relapsed or your lymphoma has not responded OR you have had one course but are unable to have a stem cell transplant.
- Your lymphoma is measurable by the tests used in the trial.
- You are well enough to look after yourself and are up and about more than 50% of your waking hours, even if you are not well enough to work.
- You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant.
- Your blood and other health test results are satisfactory.
- You are over 18.
You will not be able to enter if:
- You have any type of infection in the 2 weeks before starting the trial treatment.
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord) unless this has been successfully treated.
- You’ve had any other cancer treatment in the last 4 weeks.
- You have had a donor (allogeneic) stem cell transplant.
- You have HIV, hepatitis C or hepatitis B.
- You have had another cancer that’s been in remission for less than a year, except certain localised cancers.
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
- You have any nerve problems, for example pins and needles or numbness in your fingers and toes.
- You are pregnant or breastfeeding.
- Any of the study drugs are not suitable for you.
- You have been treated with brentuximab vedotin or bendamustine before.
- You’ve had a bad reaction to rituximab in the past.
- You are currently having any other new drugs as part of another clinical trial.
More information about this trial is available at clinicaltrials.gov.