
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 lenalidomide (Revlimid) as treatment for B cell chronic lymphocytic leukaemia (B cell CLL) in elderly people. This trial is open to people with B cell CLL aged 65 years or older.
Doctors often treat B cell CLL with chlorambucil, which is a chemotherapy drug. This trial is looking at comparing chlorambucil with lenalidomide.
Lenalidomide is a biological therapy. It mainly works by helping the body’s immune system target cancer cells.
The aims of this trial are to compare lenalidomide with chlorambucil to treat elderly people with B cell CLL.
You may be able to enter this trial if you have B cell lymphocytic leukaemia (B cell CLL) and have at least one of the following situations
And
You cannot enter this trial if
This is a phase 3 international trial. It will recruit 428 people from different countries around the world. It is a randomised trial. You are put into 1 of 2 treatment groups. Neither you nor your doctor can choose which group you are in. You will have either lenalidomide or chlorambucil.
Lenalidomide is a tablet. You take it daily with a glass of water. You continue taking it as long as it is helping you and the side effects aren’t too bad.
Chlorambucil is a tablet. You take it every 2 weeks with a glass of water. You continue taking it for a year as long as it is helping and the side effects aren’t too bad.
When you start lenalidomide, you may have an increase in symptoms. This is called . This is a reaction to starting treatment and does not mean your cancer is getting worse. Your doctor may give you medication to control this.
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 and is called tumour lysis syndrome. Your doctor will give you medication to control this.
The trial team will ask you to fill out a questionnaire before you start treatment and then every 2 months during your treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
The trial team will also ask for some extra blood samples during the trial. They will use these samples to look for substances they can measure that tell them more about B cell CLL and how the treatment is working – these are called biomarkers. Samples will be stored safely and may be used in the future, but only for research purposes. You do not have to take part in the biomarker study if you don’t want to, you can still take part in the main trial.
You see the doctor and have some tests before taking part in this trial. These tests include
During treatment you see the doctor regularly for a physical examination and blood tests. You have a heart trace every 4 months.
When you stop treatment you see the doctor and have
After treatment the trial team will contact you every 4 months to see how you are.
The most common side effects of lenalidomide are
Lenalidomide can also cause a temporary increase in symptoms ().
The most common side effects of chlorambucil are
Your doctor will discuss all the possible side effects before you agree to take part in the trial.
We have more information on lenalidomide and chlorambucil in our cancer drugs section.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr David Oscier
Celgene Corporation
Experimental Cancer Medicine Centre (ECMC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.