A trial looking at lenalidomide (Revlimid) for B cell chronic lymphocytic leukaemia that has responded to second line chemotherapy (The CONTINUUM Trial)

Who can enter

You can enter this trial if you

• Have B cell CLL
• Have already had two different types of chemotherapy to treat your CLL (in other words, have had first and second line chemotherapy)
• Have had a chemotherapy drug called fludarabine, bendamustine or alemtuzumab (your doctor can advise about this)
• Responded to the second line chemotherapy (your doctor can advise about this)
• Finished chemotherapy between 8 and 20 weeks ago
• Are well enough to take part (performance status 0,1,2)
• Are willing to use reliable contraception from 4 weeks before the trial until 4 weeks after if there is any chance that you or your partner could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have CLL that has changed to Richter’s syndrome or polymorphocytic leukaemia
• Have leukaemia that has spread to your brain or spinal cord (central nervous system)
• Have an infection that is being treated with antibiotics and has not cleared up 2 months before starting lenalidomide
• Have had a bone marrow transplant as a part of second line therapy
• Are pregnant or breastfeeding
• Have had another drug as part of a clinical trial in the last 4 weeks, unless it was another CLL trial
• Have another serious medical condition that could affect you taking part in this trial
• Have had another cancer, unless it has been in complete remission for at least 5 years, apart from non melanoma skin cancer, carcinoma in situ of the cervix or breast, or prostate cancer that is stage 1
• Have had kidney dialysis
• Are known to be HIV, hepatitis B or hepatitis C positive
• Have had lenalidomide before
• Had a bad rash after taking thalidomide
• Are allergic to allopurinol
• Have a thyroid problem (your doctor can advise about this)
• Had a blood clot in the last year
• Have had damage to your nerves (neuropathy) from previous chemotherapy

Trial design

This is a phase 3 international trial. It will recruit about 400 people from different countries around the world. It is a randomised trial. The people taking part are put into one of two treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are put in or be told which group you are in. This is common in clinical trials and is called a double blind trial.

Half the people will have lenalidomide. The other half will have a dummy drug (placebo).

You take lenalidomide or a placebo tablet every day. You start with a low dose. After 4 weeks, if you are well, your doctor may increase the dose. You may have another dose increase 5 months after that.

Exactly how long you have the treatment will depend on how well you are, and on whether your leukaemia comes back.

When you start lenalidomide, you may experience an increase in symptoms. This is called tumour flare. This is a reaction to starting treatment and does not mean your cancer is coming back. Your doctor may give you medication to control this.

When you start lenalidomide, you may still have some leukaemia cells around. When cancer cells die, chemicals in the cells are suddenly released into your blood. This changes the normal balance of chemicals circulating in your body. This is called tumour lysis syndrome. Your doctor will give you medication to control this.

You will be asked to fill in 2 questionnaires before you start your treatment and then every 8 weeks till you finish treatment. They will ask about any symptoms you have had and how you are feeling. This is called a quality of life study.

Hospital visits

You will see the doctor and have some tests before you start treatment. These tests include

• Physical examination
• Blood tests
• Heart trace (ECG)
• Pregnancy test (if appropriate)
• Bone marrow test
• CT scan

During treatment, every 4 weeks you will have a

• Physical examination
• Blood test
• Pregnancy test (if appropriate)

Every 4 months during treatment you will have a heart trace (ECG) and blood tests. When treatment stops you will have a

• Physical examination
• Blood test
• Heart Trace (ECG)

During and after treatment your doctor will talk to you about how often they need to see you. If they think you need to have any other tests or scans, they will discuss this with you.

Side effects

All treatments have side effects. The most common side effects of lenalidomide are

• Fatigue
• A drop in blood cells causing an increased risk of infection, bruising, bleeding problems and shortness of breath
• Constipation
• Diarrhoea
• Feeling sick
• Loss of appetite
• Back or joint pain
• Muscle cramps
• Difficulty sleeping
• Fever
• Swollen arm or legs
• Rash or itchy skin
• Dizziness
• Headache
• Lack or loss of strength
• Cough or infection in your upper airways

Lenalidomide can also cause a temporary increase in symptoms (tumour flare). Your doctor will discuss all the possible side effects before you agree to take part in the trial.