Purpose of trial
The aim of the trial is to see if a chemo-immunotherapy (chemotherapy with antibody therapy) regimen (combination of drugs) that includes lenalidomide is as effective as a standard chemo-immunotherapy regimen for people with diffuse large B-cell lymphoma (DLBCL) that has relapsed (come back) or was refractory (didn’t respond) to previous treatment.
Lenalidomide is an immunomodulatory drug. It affects the activity of the immune system in several different ways, both in helping the immune system to attack the lymphoma cells and in preventing the lymphoma from growing.
Participants are randomised to decide which chemo-immunotherapy regimen they will have:
- R-GEM-P is often used for people with relapsed or refractory DLBCL. It includes the antibody treatment rituximab with the chemotherapy drugs gemcitabine and cisplatin and the steroid methylprednisolone.
- LR-GEM is the new combination being tested. It includes the test drug lenalidomide in combination with rituximab, gemcitabine and methylprednisolone (no cisplatin).
You can’t choose which treatment you have and neither can your doctor.
You have the chemotherapy drugs intravenously (through a drip into a vein). You take methylprednisolone and lenalidomide as tablets.
Treatment is given in cycles of 4 weeks. You have treatment on some days, followed by a rest period to allow your body to recover before the next cycle. You have 3 cycles of treatment with scans after cycle 1 and cycle 3 to see how your lymphoma is responding.
If you respond to treatment, your doctor might recommend you have a stem cell transplant.
Who can enter
Your consultant can give you advice on whether this trial might be suitable for you.
Around 92 people are needed for this trial.
You may be able to enter if:
- You have DLBCL that has CD20 protein on its surface. A biopsy must be available.
- Your lymphoma has relapsed after or was refractory to a previous treatment that contained rituximab and a chemotherapy drug grouped as an anthracycline, eg doxorubicin.
- Your lymphoma is measurable by the tests used in the trial.
- 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.
- You and your partner are willing to use reliable contraception for at least a month before treatment starts, during treatment and for at least a year after treatment has finished if there is any chance of you or your partner becoming pregnant.
- Your blood test results are satisfactory.
- You are 18 or over.
You will not be able to enter if:
- Your lymphoma is in your central nervous system (brain and spinal cord).
- You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
- You’ve had another cancer in the last 5 years, unless it was one from a group of certain localised cancers.
- You have been treated with certain other drugs or as part of another clinical trial within the 21 days before you start trial treatment.
- You have hearing problems that might worsen if you are given cisplatin.
- You have been treated with lenalidomide before.
- You are not able to have any of the study drugs due to your health or a bad reaction to one of the study drugs in the past.
- You have had a stem cell or organ transplant.
- You are HIV positive or have active hepatitis C or active hepatitis B.
- You are pregnant, breastfeeding or intending to have a child within a year of completing trial treatment.
More information about this trial is available at clinicaltrials.gov.