A trial looking at ofatumumab for chronic lymphocytic leukaemia

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)




Phase 3

This trial is comparing a drug called ofatumumab to other treatments for chronic lymphocytic leukaemia that has got worse or come back despite having another drug called fludarabine.

Doctors can treat chronic lymphocytic leukaemia (CLL) with chemotherapy. One of the drugs they commonly use is fludarabine. But sometimes the leukaemia gets worse or comes back after treatment. Doctors call this fludarabine refractory CLL. This trial is for people with fludarabine refractory CLL who also have enlarged lymph nodes.

Ofatumumab (also called Arzerra) is a type of biological therapy called a monoclonal antibody.

The aim of this trial, is to see if ofatumumab helps people with CLL that has got worse despite having fludarabine.  The researchers will compare ofatumumab with other treatments doctors can offer.

Who can enter

You may be able to enter this trial if you

  • Have chronic lymphocytic leukaemia (CLL) and need treatment
  • Have at least 1 lymph node that measures more than 5cm
  • Have already had at least 2 other types of treatment for CLL
  • Have had at least 2 cycles of treatment that included the drug fludarabine and your leukaemia didn’t get any better, or if it did respond to treatment, the response lasted for less than 6 months
  • Have satisfactory blood test results
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Are at least 18 years old

You cannot enter this trial if you

  • Have prolymphocytic leukaemia or Richter’s syndrome
  • Have CLL cells in your brain or spinal cord
  • Have a condition called autoimmune haemolytic leukaemia Open a glossary item that needs treatment (unless this is the same treatment you have for your CLL)
  • Have ever had a stem cell transplant Open a glossary item using a donor’s cells, or in the last 6 months have had a transplant using your own cells
  • Have had another experimental drug in the last 4 weeks
  • Have an infection that needs treatment or another medical condition that the trial doctors think could affect you taking part
  • Have had another type of cancer apart from carcinoma in situ of the cervix or basal cell skin cancer, or any other type of cancer that was treated successfully at least 2 years ago
  • Take steroids Open a glossary item unless it is a low, stable dose
  • Are known to be very sensitive to ofatumumab
  • Are HIV positive
  • Are pregnant or breastfeeding

Trial design

The trial will recruit about 120 people. The trial is randomised. The people taking part are put into treatment groups at random. Neither you nor your doctors can decide which group you are in.

  • People in group A have ofatumumab
  • People in group B have another treatment chosen by their doctor

There will be twice as many people in the ofatumumab group as in the doctor’s choice group.

If you are in group A, you have ofatumumab though a drip into a vein once a week for 8 weeks and then once every 4 weeks for up to 6 months. If your leukaemia gets better, or at least stays the same (stable disease Open a glossary item), you can be randomised again. People in one group have another 6 months of ofatumumab. People in the other group have no further treatment. Once again, there will be twice as many people in the ofatumumab group as in the no further treatment group.

If you were in the doctor’s choice group (group B) and your leukaemia gets worse, you may then be able to have ofatumumab.

The trial team will ask you to fill out a questionnaire before you start treatment and then at every hospital visit. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

The researchers will also ask you to give an extra blood sample that they can use to study your genes. They hope to learn more about how genes affect the way different people respond to the trial drug and the side effects they have. This is called pharmacogenetics Open a glossary item. If you don’t want to give this sample for research, you don’t have to. You can still take part in the trial.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

If you are in the ofatumumab group, you go to hospital

  • Once a week for the first 8 weeks
  • Once every 4 weeks for up to 6 months
  • Once every 4 weeks for another 6 months if you are randomised to have a further 6 months of ofatumumab treatment

If you stop having ofatumumab after 6 months, you then see the trial team every 8 weeks for 6 months and every 3 months after that.

If you are in the doctor’s choice group, the number of hospital visits you have will depend on the treatment you have.

Everybody taking part will continue to see the trial team once every 3 months for up to 5 years after finishing treatment.

Side effects

The most common side effects of ofatumumab include

  • Rash
  • Chills or shivers (rigors)
  • Sore throat or cough
  • Difficulty breathing
  • High temperature (fever)
  • Itching
  • Flushing
  • Pain
  • Tiredness (fatigue)
  • Increased heart rate or change in heart rhythm
  • Diarrhoea
  • Changes to your blood pressure
  • Feeling sick

We have more information about other possible side effects of ofatumumab in our cancer drugs section.

If you are in the doctor’s choice group, the side effects will depend on the treatment you have.

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

Dr Anna Schuh

Supported by

GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 8234

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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