Purpose of trial
The aim of this trial is to find out if adding atezolizumab to a standard treatment regimen (combination of drugs) can improve outcomes for people with DLBCL.
The R-GemOx chemotherapy regimen is often used for people who have DLBCL that has come back (relapsed) or didn’t respond to previous treatment (refractory), if they are not fit enough for stronger treatment.This trial aims to find out more about the combination of atezolizumab and R-GemOx, including:
- if adding atezolizumab to the regimen can increase the time people live without their DLBCL coming back
- what side effects this combination has.
Atezolizumab is a checkpoint inhibitor, which allows your immune system to recognise and kill the lymphoma cells. It is a targeted drug that is already used for some other types of cancer and is being tested for people with lymphoma in clinical trials.
R-GemOx is a combination of:
- the antibody treatment rituximab (R)
- two chemotherapy drugs: gemcitabine (Gem) and oxaliplatin (Ox).
This is a randomised trial. Half of the people who take part have standard treatment, R-GemOx alone, and the other half have R-GemOx with atezolizumab. You can’t choose which treatment you have and neither can your doctor – the treatment is chosen at random by a computer. You are told which treatment you are having and given information about it.
Everyone in this trial has the three drugs that make up R-GemOx once every 14 days – this is a cycle of treatment. You can have up to 6 cycles of treatment.
If you are also having atezolizumab, you have R-GemOx alone for the first cycle, then atezolizumab is added to R-GemOx for the next five cycles. If you are in this group, you can also have maintenance treatment with atezolizumab. Maintenance treatment aims to ‘mop up’ any remaining lymphoma cells and reduce the risk of the lymphoma coming back. For maintenance treatment, you have atezolizumab on its own once every 21 days for up to 8 more cycles.
All of the drugs are given intravenously (into a vein).
Who can enter
Your consultant can give you advice on whether you might be suitable for this trial.
Approximately 112 people are needed for this trial.
You may be able to enter if:
- You have DLBCL.
- A sample of your biopsy is available for tests.
- You have previously had at least one course of treatment for your lymphoma that included rituximab and standard chemotherapy.
- You can’t have high-dose chemotherapy or a stem cell transplant.
- Your lymphoma is measurable by the tests used in the trial.
- You are well enough to take part in the trial.
- Your blood and other health test results are satisfactory.
- You and your partner are willing to use at least two forms of reliable contraception throughout the trial and for at least 12 months after finishing trial treatment if there is any chance of you or your partner becoming pregnant.
- You are 16 or over.
You won’t be able to enter if:
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment, for example heart problems or autoimmune conditions (where your body attacks itself).
- You still have significant side effects from your previous treatment.
- You’ve had gemcitabine in the last 3 months and your DLBCL has since relapsed.
- You’ve had gemcitabine before and didn’t respond to it (you can take part if you’ve had gemcitabine and did respond to it, as long as you didn’t relapse within the next 3 months).
- You’ve had other anti-cancer drugs or radiotherapy (unless only to a certain area to control symptoms that needed urgent treatment) in the last 2 weeks.
- You’ve had major surgery in the last 4 weeks.
- You’ve ever had a donor (allogeneic) stem cell transplant.
- You’ve had a live vaccine in the last 28 days or your doctor thinks you might need a live vaccine during the trial within 5 months after your last dose of atezolizumab.
- You’ve had another experimental treatment in the last 4 weeks.
- You’ve had a stroke or bleeding in your brain in the last 6 months.
- You have peripheral neuropathy (nerve damage) that is causing significant problems.
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You have serious problems with your lungs.
- You have or have had an infection that needed intravenous antibiotics or treatment in hospital in the last 2 weeks.
- You have HIV, hepatitis C or hepatitis B.
- You have had another cancer in the last 2 years, except certain localised cancers.
- You are pregnant or breastfeeding.
- You’ve had a bad reaction to the trial treatments or any of their ingredients in the past.
More information about this trial is available at clinicaltrials.gov/ct2/show/NCT03422523.