"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at lenalidomide for diffuse large B cell lymphoma
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at lenalidomide (Revlimid) for diffuse large B cell lymphoma (DLBCL) that has continued to grow during treatment, or come back after treatment.
DLBCL is one of the most common types of high grade non Hodgkin lymphoma. The
We know from research that there are 2 distinct sub types of DLBCL. The type you have depends on the activity of genes in your lymphoma cells. As part of this trial, researchers will use a technique to look at the genes in each person’s lymphoma cells and see which type they have. They will then compare how well treatment works for people with each sub type.
The aims of this trial are to
- See if knowing the genetic sub type can help to show who is most likely to benefit from treatment
- Compare lenalidomide with the chemotherapy drugs already used
Who can enter
You may be able to enter this trial if
- You have diffuse large B cell lymphoma (DLBCL)
- Your doctor thinks your treatment can wait for you to have genetic sub typing – you can ask your doctor about this
- You have had treatment with rituximab, an anthracycline drug such as doxorubicin or epirubicin and one of the following ifosfamide, gemcitabine, etoposide or a
platinum drugsuch as carboplatin or cisplatin
- Your doctor feels you aren’t suitable for a stem cell transplant
- You have lymphoma that is at least 2cm across and can be measured on a scan
- You have satisfactory blood test results
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You are willing to use reliable contraception for a month before starting treatment and for a month afterwards if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Have lymphoma of the brain or spinal cord unless it has been treated and you’ve had no symptoms for 3 months
- Are able to have a stem cell transplant or combination chemotherapy
- Have had a donor stem cell transplant and needed to have
- Have already had lenalidomide
- Have had another cancer in the past 5 years apart from non melanoma skin cancer,
carcinoma in situof the cervix or breast or early stage prostate cancer (stage 1a or 1b)
- Have severe nerve damage
- Are at high risk of developing blood clots and are not willing to take medication to prevent them
- Have an infection and you are having antibiotics through a drip (
- Have diabetes that is poorly controlled (with unstable blood sugar levels)
- Have had a heart attack in the past 6 months, heart pain (angina), chronic congestive heart failure (CCF) or another serious heart condition
- Are known to be HIV, hepatitis B or hepatitis C positive
- Have any other medical condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
This is a phase 2/3 trial. It is a randomised trial. You will be put into groups. Neither you nor your doctor can choose which group you are in. There are 2 stages to this trial. The first stage will recruit 100 people. If this goes well the second stage will recruit another 148 people.
If you are in the first stage, the researchers will first test your lymphoma to find out the subtype.
Everyone taking part in the trial will be randomised to have lenalidomide or another drug chosen by their doctor. Your doctor can choose from gemcitabine, rituximab, etoposide or oxaliplatin.
Lenalidomide is a capsule. You have lenalidomide as long as the side effects are not too bad and your doctor feels the treatment is helping you.
You have etoposide as a capsule or a drip into a vein. You have gemcitabine, rituximab and oxaliplatin as a drip into a vein. You can have these for up to 6 months if the side effects are not too bad and your doctor feels the treatment is helping you.
If your doctor can see on a scan that your lymphoma is getting worse you may be able to switch to lenalidomide before the 6 months is up. Your doctor will discuss this with you if relevant.
If you agree to take part in the trial, the researchers will ask your permission to take a tissue sample and blood samples. If you don’t want to give samples for the trial you don’t have to. You can still take part.
In stage 2 the researchers will also ask you to fill out a questionnaire before you start treatment, at regular times during treatment and after 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 doctor and have some tests before taking part in this trial. These tests include
- A physical examination
- Heart trace (
- Sample of the fluid from around the brain and spinal cord (lumbar puncture)
- Blood tests
- CT scan and PET scan
- Bone marrow test
During treatment you see your doctor regularly for a physical examination and blood tests.
You have a CT scan every 8 weeks for 2 years and then every 6 months.
If you stop treatment because your lymphoma comes back or starts to grow again you see the doctor every 3 months. If you stop treatment for any other reasons you see the doctor every 2 months for 2 years and then every 6 months until your lymphoma comes back or starts to grow again.
For as long as you agree, the research team will telephone you to see how you are and find out if you have started any other treatment.
The most common side effects of lenalidomide are
- Feeling tired (fatigue)
- A drop in blood cells causing increased risk of infection, bruising, and bleeding problems
- Constipation or diarrhoea
- Feeling or being sick
- Loss of appetite or taste changes
- Pain in your back, joints, muscles, bones or tummy (abdomen)
- Rash or itchy skin
- Shaking (tremor)
- Loss of strength
- Swelling of your arms or legs
- Nerve changes (
- Blood clots in your lungs or blood vessels (deep vein thrombosis - DVT)
- Shortness of breath or difficulty catching your breath
- Cough or infection in your nose, throat or lung
- Blurred vision
- A drop in the amount of potassium in your blood
The most common side effects of gemcitabine, etoposide, oxaliplatin and rituximab can include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Shortness of breath
- Feeling or being sick
- Hair loss
- Flu like symptoms
- Mood changes
This is not a complete list of side effects and your doctor will talk to you about other possible side effects before you agree to take part in the trial.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof David Cunningham
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)