
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called lenalidomide alongside rituximab for low grade lymphoma that has got worse or come back despite having other treatment.
Certain types of non Hodgkin lymphoma are slow growing. They are called low grade or indolent lymphoma. This trial is for people who have types of low grade lymphoma called follicular lymphoma and marginal zone lymphoma.
Doctors can treat these low grade lymphomas with treatments such as a drug called rituximab, or a combination of chemotherapy and rituximab.
But low grade lymphoma can get worse during treatment, or come back afterwards. If that happens, there are various treatments that doctors can use. In this trial, researchers are looking at a drug called lenalidomide alongside rituximab.
Lenalidomide is called an immunomodulatory agent. It affects how your immune system works.
The aim of the trial is to see how well the combination of rituximab and lenalidomide works, and how safe it is compared to rituximab alone.
You may be able to join this trial if all of the following apply. You
As well as the above, if you’ve already had rituximab, your lymphoma must have responded to it and didn’t start getting worse for at least 6 months after the last dose you had.
You cannot join this trial if any of these apply. You
This is a phase 3 trial. The researchers need about 350 people to join.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
People in one group have rituximab and lenalidomide. People in the other group have rituximab and a dummy drug ().
You have treatment in 4 week periods called cycles of treatment.
In the 1st cycle of treatment, you have rituximab through a drip into a vein once a week. So you have it 4 times in the first treatment cycle. You then have it just once in each of the next 4 cycles of treatment.
You have lenalidomide (or the dummy drug) as tablets once a day for the first 3 weeks of each treatment cycle.
You only have rituximab in the first 5 cycles of treatment. But as long as you don’t have bad side effects, and your lymphoma doesn’t get worse, you can carry on taking lenalidomide (or dummy tablets) for up to a year.
The trial team will ask you to fill out a questionnaire before you start treatment, every 3 cycles during treatment and 6 months after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial team and have some tests before you start treatment. The tests include
You may also need to have a bone marrow test, a lumbar puncture and a lymph node biopsy.
If you have a type of marginal zone lymphoma called MALT lymphoma that started in your stomach, you will need to have an endoscopy (if you haven’t had one in the last 3 months). This is a test using a flexible tube with a camera attached. The doctor puts the tube down your throat and uses it to look at the inside of your stomach. During the test, the doctor can take samples of tissue ().
If your lymphoma responds well to the trial treatment, you will have more endoscopies, so that the trial team can get more samples of your lymphoma to study.
Everybody taking part sees the trial team and has blood tests at least every 4 weeks during treatment. You have a CT or MRI scan every 3 months for 3 years, every 4 months in the following year, every 6 months in the following year and once a year after that.
When you finish treatment, the trial team will continue to check how you are every 6 months for at least 5 years. Depending on your indiviudal situation, this may be at hospital visits, or by phone.
The most common side effects of lenalidomide include
The most common side effects of rituximab include
We have more information about
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor J Gribben
Celgene Corporation
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.