A trial looking at lenalidomide for B cell chronic lymphocytic leukaemia

Who can enter

You can enter this trial if you

• Have B cell chronic lymphocytic leukaemia (B cell CLL) that has come back after treatment or has not responded to treatment
• Have had at least 1 type of chemotherapy like fludarabine, pentotstatin, cladribine or bendamustine for your B cell CLL
• Have satisfactory blood test results
• Are well enough to be up and about for half the day (performance status 0, 1 or 2)
• Are willing to use reliable contraception from 4 weeks before the start of the trial until 4 weeks after the trial has finished if there is a chance that you or your partner could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have leukaemia that has spread to your brain or spinal cord (central nervous system)
• Have CLL that has changed to Richter’s syndrome or prolymphocytic leukaemia
• Have had lenalidomide before
• Have an infection that is being treated with antibiotics
• Are to have a bone marrow transplant as a part of your treatment
• Have had alemtuzumab (Campath) in the 8 weeks before starting lenalidomide
• Have had treatment for your B cell CLL within 4 weeks of starting lenalidomide
• Have had another drug as a part of a clinical trial in the 4 weeks before starting lenalidomide
• Had a bad rash after taking thalidomide
• Have had another cancer, unless it was successfully treated and there has been no sign of it (complete remission) for at least 2 years (you may join the trial if you have non melanoma skin cancer, carcinoma in situ of the cervix,breast, bladder or prostate cancer that is stage 1)
• Have had kidney dialysis
• Have a thyroid problem (your doctor can advise about this)
• Have damage to your nerves
• Have had a blood clot in the last year
• Are known to be HIV, hepatitis B or hepatitis C positive
• Have another serious medical condition that could affect you taking part in this trial

Trial design

This is a phase 2 international trial. It will recruit about 90 people. It is a randomised trial. The people taking part are put into one of 3 treatment groups by a computer. Neither you nor your doctor will be able to choose which group you are in, or be told which group you are in. This is common in clinical trials and is called a double blind trial.

Everyone taking part will have lenalidomide. You take lenalidomide once a day, every day for 4 weeks. This is called a cycle of treatment.

You start at a low dose. After 4 weeks, if you are well, your doctor will increase the dose. As long as you are well enough, your dose will increase every 4 weeks, until you are having the maximum dose.

Exactly how long you have treatment will depend on how well you are, and if it is still helping.

When you start lenalidomide, you may have an increase in symptoms. This is called tumour flare. It is a reaction to starting treatment and does not mean your leukaemia is getting worse. 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 tell you to drink more water and give you medication to prevent it.

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.

The researchers may ask you to take part in up to 2 extra studies. You can choose whether you want to join any or all of them. Your choice will not affect you taking part in the main trial.

The first is looking at what happens to lenalidomide when it is in the body. This is called a pharmacokinetic study. If you take part in this study, you cannot eat after your last meal the night before having the first dose of lenalidomide, and for 3 hours after taking the lenalidomide. You go to the hospital to have the first dose of lenalidomide and have several blood samples taken at regular times up to 8 hours after. You have other blood samples taken

• At the 2nd cycle of treatment
• Each time your lenalidomide is increased

In the second study the researchers want to find out how lenalidomide affects the tissues, cells and biomarkers in your lymph glands. The doctor will use a needle to take a small piece of tissue (biopsy), or fluid (fine needle aspirate - FNA) from your lymph gland. You have one biopsy, or fine needle aspirate, taken before you start taking lenalidomide. If you have an increase in symptoms while taking the lenalidomide (tumour flare) you will have another biopsy, or fine needle aspirate, taken.  If you are having the fine needle aspirate, you will have these at different times up to a total of 4.    

Hospital visits

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

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

During treatment you will see the doctors regularly. To begin with this will be at least once a week, then once a month.

When you first start treatment, and when your dose is increased, you will have 2 extra visits.

Every 3 months you will have a 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

• Feeling tired (fatigue)
• A drop in blood cells that can cause an increased risk of infection, bruising, and bleeding problems
• Constipation
• Diarrhoea
• Feeling sick
• Loss of appetite or taste changes
• Pain in your back, joints, muscles, bones or tummy (abdomen)
• Fever
• Rash or itchy skin
• Dizziness
• Shaking (tremor)
• Headache
• Lack or loss of strength
• Swelling of your arms or legs
• Nerve changes (peripheral neuropathy)
• 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 airways
• Nosebleed
• Blurred vision
• A drop in the amount of potassium in your blood

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.