A trial looking at treatment for high risk chronic lymphocytic leukaemia (CLL 210)

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 2

This trial is looking at a new combination of treatment for high risk chronic lymphocytic leukaemia (CLL). High risk CLL is more difficult to treat and more likely to come back after treatment. This trial is supported by Cancer Research UK.

Doctors often treat chronic lymphocytic leukaemia (CLL) with chemotherapy or biological therapy. This can work well and there is no sign of the leukaemia (it goes into remission Open a glossary item). But sometimes it doesn’t work very well and doctors are keen to improve treatment so that more people go into remission.

Some leukaemia cells have a faulty (mutated) or missing gene called p53 Open a glossary item. If the cells have this fault, the leukaemia is classed as high risk.

The trial is looking at a new combination of 3 drugs known as ROD (Revlimid, ofatumumab, dexamethasone). This is called induction therapy and the aim is for the leukaemia to go into remission. The drugs are

Please note people who agreed to take part in this trial before 11th September 2012 had the following combination of drugs - alemtuzumab, dexamethasone and lenalidomide (CamDexRev).

The trial also looked at the longer term use of lenalidomide. This is called maintenance therapy and the aim is for the leukaemia to stay in remission for as long as possible. This part of the trial is now closed.

The aims of this trial are to find out

  • How well ROD works as induction therapy for high risk chronic lymphocytic leukaemia
  • More about the side effects
  • How these treatments affect quality of life

Who can enter

You may be able to take part in this trial if you have chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) that is classed as high risk. SLL is almost the same as CLL. High risk means either

  • You have CLL or SLL that didn’t go into remission with treatment containing fludarabine, or
  • You have CLL or SLL that has come back within a year of having treatment containing fludarabine, or
  • At least 1 in 5 (20%) of your leukaemia cells have a faulty or missing p53 gene

As well as that, you must

  • Have satisfactory blood test results
  • Be well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Be prepared to use reliable contraception

You cannot enter this trial if you

  • Have leukaemia or lymphoma in your brain or spinal cord
  • Have had ofatumumab or lenalidomide before
  • Have had steroids for your CLL before and they didn’t work
  • Have had surgery in the last 4 weeks
  • Have taken part in another clinical trial in the last 4 weeks
  • Have an infection
  • Have inflammation of the stomach or a stomach ulcer
  • Have diabetes or high blood pressure
  • Have had blood clots in the past
  • Have got Hepatitis B, Hepatitis C or HIV
  • Have CLL that has changed into a fast growing diffuse B cell lymphoma (this is called Richter’s transformation)
  • Have had any other cancer in the last 5 years, apart from non melanoma skin cancer that was successfully treated
  • Have any other serious medical condition
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial that will now recruit 66 people with high risk CLL or SLL.

People recruited before 11th September 2012 had the monoclonal antibody alemtuzumab instead of ofatumumab. The researchers decided to change to ofatumumab because it became difficult to get alemtuzumab from the manufacturers. They expect the combination of lenalidomide, ofatumumab and dexamethasone (ROD) to work just as well as alemtuzumab, dexamethasone and lenalidomide (CamDexRev). They also expect it to have fewer side effects.

When the combination was changed 16 people had been recruited to have CamDexRev. The trial will recruit another 50 people to have ROD. This will make a total of 66 people recruited into this trial.

Everyone taking part has ROD induction therapy for 6 months. During that time you

  • Take dexamethasone tablets for a few days each week for 4 months
  • Take lenalidomide capsules every day for 5 months
  • Have ofatumumab as an injection into the vein once a week for 8 weeks then once a fortnight for 8 weeks

After this the doctors will look to see how well the treatment has worked.

If the treatment has not worked very well you will stop being part of the trial and continue to see your own doctor for treatment.

If the treatment has worked well and you are suitable, you will be offered a bone marrow or stem cell transplant.

If the treatment has worked well but you aren't suitable for a bone marrow or stem cell transplant, you see the trial team every 2 months to see how you are getting on.

The research team may also ask you if you'd like to take part in a study called the 100,000 Genome Project. If you agree to take part in this study, the research team will send a sample of your cancer cells to the team running the project, so that they can look at the genetic material (DNA) in the cells. They plan to collect information from 100,000 people so that they can learn more about different medical conditions, including cancer. The research team will explain the project to you in more detail. If you don’t want to agree to take part in this project, you don’t have to. You can still take part in the CLL 210 trial.

Hospital visits

You see the doctors and have some tests before you can take part in this trial. These tests include

The treatments in this trial are either tablets or injections you have into the skin. So you should be able to have treatment as an out patient or at home.

You have blood tests regularly during the trial. You have a CT scan and bone marrow test about 6 months and 2½ years after joining the trial.

 After your treatment has finished, you will see the trial doctors every 2 months.

You fill out a questionnaire before you start treatment and then 6 times during the trial. It will ask about side effects and how you’ve been feeling. This is called a quality of life questionnaire.

Side effects

As with all treatments, those used in this trial have some side effects. The most common side effects of dexamethasone are

  • Indigestion or heartburn
  • Water retention causing swollen hands or feet
  • Increase in blood sugar levels
  • Changes in mood or behaviour
  • Increased blood pressure
  • Increased risk of infection

The most common side effects of ofatumumab are

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Pain, swelling or redness at the injection site
  • Infection
  • A short term increase in proteins (enzymes) produced by the liver

Another side effect of ofatumumab is something called an infusion reaction. This is more likely to happen with the first dose and is usually mild, but can be more serious. Signs of an infusion reaction include a rash, chills or fever, a cough or sore throat, shortness of breath, itching and a change in blood pressure or pulse rate. If you do have a reaction, it will be less of a problem with other doses.

The most common side effects of lenalidomide include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Tiredness (fatigue) or feeling weak
  • Muscle cramps and pain
  • Dizziness
  • Rash, dry skin or itching

Lenalidomide can cause birth defects in children. So you must not become pregnant or father a child while taking it.

 

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Prof A Pettitt

Supported by

Baxter Ltd
Cancer Research UK
Cancer Research UK Liverpool Cancer Trials Unit (LCTU)
Celgene Ltd
Chugai Pharmaceutical Co Ltd
GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer
Royal Liverpool and Broadgreen University Hospital NHS Trust
University of Liverpool

Other information

This is Cancer Research UK trial number CRUKE/09/035.

Contact our cancer information nurses for other questions about cancer by:

Phone - 0808 800 4040

Last review date

CRUK internal database number:

Oracle 3492

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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