A trial looking at lenalidomide for B cell chronic lymphocytic leukaemia in elderly people (The ORIGIN Trial)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers

Chronic leukaemia

Chronic lymphocytic leukaemia (CLL)

Leukaemia

Status:

Closed

Phase:

Phase 3

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.

Who can enter

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

Very enlarged lymph nodes or very enlarged spleen
High number of white blood cells
A low number of red blood cells (anaemia) or platelets (thrombocytopenia )
A fever for the past 2 weeks, or night sweats for the past month, with no signs of infection
Unintentional weight loss in the past 6 months

And

Your other blood test results are satisfactory
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You and your partner are willing to use reliable contraception for 28 days before starting treatment and 28 days after if there is any chance your partner could become pregnant
You are at least 65 years old

You cannot enter this trial if

You have B cell CLL that is in your brain or spinal cord
You have B cell CLL that has changed to Richter’s Syndrome or prolymphocytic leukaemia
You have already had treatment for B cell CLL
You have already had lenalidomide or chlorambucil
You had an infection in past 2 months or are taking antibiotics for an infection
You have had kidney dialysis
You have had a blood clot in the past year
You have moderate to severe nerve pain
You have had another cancer unless there has been no sign of it for at least 5 years apart from non melanoma skin cancer, in situ carcinoma of the cervix, breast or bladder, or early stage prostate cancer (stage T1)
You are HIV, hepatitis B or hepatitis C positive
You are allergic to allopurinol
Your doctor thinks your use of alcohol or drugs is a cause for concern
You have any other medical condition that could affect you taking part in this trial

Trial design

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 tumour flare Open a glossary item . 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.

Hospital visits

You see the doctor and have some tests before taking part in this trial. These tests include

A physical examination
Blood tests
CT scan
Heart trace (ECG )
Bone marrow test

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

A physical examination
Blood tests
Heart trace

After treatment the trial team will contact you every 4 months to see how you are.

Side effects

The most common side effects of lenalidomide are

Feeling tired (fatigue)
A drop in blood cells causing an increased risk of infection, bruising and bleeding
Constipation
Diarrhoea
Feeling sick (nausea)
Loss of appetite
Back and joint pain
Muscle pain and cramps
Shortness of breath
Chest infections
Difficulty sleeping
Fever
Swollen arms or legs
Rash or itchy skin
Dizziness
Headache
Weakness or loss of strength
Cough
Nose bleeds
Blood clots

Lenalidomide can also cause a temporary increase in symptoms (tumour flare Open a glossary item ).

The most common side effects of chlorambucil are

A drop in blood cells causing an increased risk of infection, bruising and bleeding
Feeling or being sick (nausea)
Diarrhoea
Muscle twitching
Loss of strength
Rash or itchy skin
Pain and numbness in hands and feet (peripheral neuropathy)

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.