Purpose of trial
The aim of the trial is to test the safety and effectiveness of a new treatment regimen for people with: DLBCL or grade 3b follicular lymphoma that has come back (relapsed) or didn’t respond (refractory) to at least 2 previous lines of treatment, or DLBCL or grade 3b follicular lymphoma who need further treatment and can’t have a stem cell transplant.
Brentuximab vedotin is an antibody joined to a strong chemotherapy drug – an antibody-drug conjugate. It is already used to treat some types of lymphoma.
Everyone in this study has bendamustine and rituximab. Participants are randomised to decide whether they also have brentuximab vedotin. 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.
All 3 drugs are given intravenously (through drips into a vein). Treatment is given in 21 day cycles for 6 cycles.
Everyone in the trial has:
- rituximab on either day 1 or day 2
- bendamustine on day 1 and day 2.
If you are in the brentuximab vedotin group, you have it on day 1 of each cycle.
If you are in the brentuximab vedotin group and respond to treatment, you can have up to 10 more cycles of brentuximab vedotin alone.
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 DLBCL or grade 3b follicular lymphoma.
- Your lymphoma is CD30 positive – your doctor can advise if this applies to you.
- Your lymphoma has relapsed or was refractory to at least 2 lines of treatment, or just 1 line of treatment if you can’t have a stem cell transplant.
- Your lymphoma is measurable on a PET scan.
- You are well enough to look after yourself and are up and about at least 50% of the day even if you are unable to work.
- Your blood and other health test results are satisfactory.
- You are willing to use reliable contraception during the trial and for at least 6 months after your last dose or brentuximab vedotin and 12 months after your last dose of rituximab.
- You are 18 or over.
You will not be able to enter if:
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You’ve had another cancer that hasn’t been in remission (no evidence of lymphoma) for at least 1 year unless it was a localised cancer and has been successfully treated.
- You’ve ever had progressive multifocal leukoencephalopathy (PML; a viral brain infection).
- You’ve had any infection in the last 2 weeks.
- You’ve had another anti-cancer treatment in the last 4 weeks.
- You’ve had an allogeneic stem cell transplant.
- You have hepatitis B or HIV or you have active hepatitis C or have been treated for hepatitis C in the last 6 months.
- You are not suitable for the study drugs, eg because of an allergy.
- You are taking part in a clinical trial of another experimental drug.
- You’ve been treated with brentuximab vedotin or bendamustine before.
- You’ve had a bad reaction to previous rituximab treatment.
- You have lung disease that isn’t related to your lymphoma.
- You have had a stroke or significant heart problems.
- You have significant peripheral neuropathy (nerve damage).
- You are pregnant or breastfeeding.
More information about this trial is available at clinicaltrials.gov.