Purpose of trial
The aim of this trial is to see if avelumab is safe and effective in treating people whose T-cell lymphoma has relapsed (come back) or was refractory (didn’t respond) to previous treatment.
The trial also aims to find out more about how T-cell lymphoma behaves.
Avelumab is an immune checkpoint inhibitor – it works by helping the immune system recognise and attack the lymphoma.
Everyone in this trial is treated with avelumab.
A cycle of treatment is 28 days and you have avelumab once every 2 weeks. You can have up to 8 cycles, but it may be possible to continue treatment for longer if you are responding well and not having any serious side effects.
Avelumab is given intravenously (into a vein).
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 36 people are needed for this trial.
You may be able to enter if:
- You have relapsed or refractory PTCL, including: PTCL not otherwise specified (PTCL-NOS), angioimmunoblastic T cell lymphoma (AITL), enteropathy associated T-cell lymphoma (EATL), extranodal NK/T- cell lymphoma, mycosis fungoides (a type of cutaneous [skin] lymphoma) that has transformed (changed) into a faster-growing type of lymphoma.
- Your relapse has been confirmed by biopsy or, for refractory lymphoma, you have had a biopsy in the last 3 months.
- You have had at least one previous course of treatment for PTCL.
- You are well enough to look after yourself and up and about more than 50% of your waking hours, even if you are not well enough to work.
- Your blood test results are satisfactory.
- Your lymphoma is measurable with the tests used in the trial.
- You and your partner are willing to use highly effective contraception during the trial and for at least 60 days after your last treatment with avelumab.
- You are aged 16 or over.
You will not be able to enter if:
- Your lymphoma is affecting your central nervous system (CNS; brain and spinal cord).
- You have had an organ transplant or an allogeneic stem cell transplant.
- You have a significant infection including HIV, hepatitis B or hepatitis C.
- You are taking immunosuppressive medication (medication to dampen down your immune system), except low doses of steroids.
- You have an autoimmune disorder (a problem where your immune system attacks your body) that might flare up if you are treated with a drug that works on your immune system.
- You have previously had a bad reaction to any of the ingredients in the trial treatment.
- You still have troublesome side effects from your previous treatment.
- You have serious heart problems.
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
- You have been vaccinated by a live vaccine in the last 4 weeks.
- You have an active infection that needs treatment.
- You have had major surgery in the last 4 weeks.
- You are pregnant or breastfeeding.
More information about this trial is available at clinicaltrials.gov.