A trial comparing ibrutinib with ofatumumab for chronic lymphocytic leukaemia or small lymphocytic lymphoma

Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Leukaemia
Low grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 3

This trial compared 2 drugs called ofatumumab and ibrutinib for chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). It was for people whose CLL or SLL had come back or stopped responding to treatment.

If you have chronic lymphocytic leukaemia (CLL), white blood cells called lymphocytes Open a glossary item are cancerous. If the cancerous lymphocytes are in your lymph nodes Open a glossary item rather than in your blood, your doctors may call it small lymphocytic lymphoma. The treatments for CLL and SLL are the same.

Doctors can treat CLL with chemotherapy. They may also use drugs called monoclonal antibodies such as rituximab or alemtuzumab. But CLL may stop responding to these drugs or come back after treatment.

Ofatumumab (pronounced oh-fat-oo-moo-mab) is another monoclonal antibody that doctors can use to treat CLL, when rituximab and alemtuzumab are no longer working. Ibrutinib (pronounced ib-root-in-ib) is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

This trial compared ibrutinib with ofatumumab to find out

  • Which works best for CLL or SLL that has come back or is no longer responding to treatment
  • More about the side effects

Summary of results

The trial team found that ibrutinib worked better than ofatumumab for people with CLL or SLL. Ibrutinib helped people to stay free of CLL or SLL for longer and increased the average time people lived.

391 people took part. Of those,

  • 195 had ibrutinib tablets
  • 196 had ofatumumab through a drip into a vein

An independent team, rather than the trial team, assessed the patients to see how well treatment worked. They were able to get results for 190 of the people in the ibrutinib group, and found that the CLL or SLL

  • Got a bit better in 122 people (just over 64%)
  • Stayed the same in 63 people (just over 33%)
  • Got worse in 5 people (just under 3%)

They were able to get results for 181 people in the ofatumumab group, and found that the CLL or SLL

  • Got a bit better in 8 people (just over 4%)
  • Stayed the same in 153 people (just under 85%)
  • Got worse 20 people (just over 11%)

Based on the above results, the doctors and the trial committee decided that people who had ofatumumab could start taking ibrutinib if their cancer got worse.

The researchers followed up the people taking part to see how many were living a year after treatment. They found that this was

  • 9 out of 10 people (90%) who had ibrutinib
  • About 8 out of 10 people (81%) who had ofatumumab

This analysis was done when 57 people who had been having ofatumumab changed treatment and were now taking ibrutinib.

The most common side effects of ibrutinib were diarrhoea, tiredness (fatigue), fever and feeling sick. And the most common side effects of ofatumumab were tiredness, a cough and a reaction to the drug causing fever, chills and flushing.

The researchers concluded that ibrutinib worked much better than ofatumumab for people with CLL or SLL, and it increased the average length of time that people lived.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the research team. We have not analysed the data ourselves.

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

Professor Peter Hilmen

Supported by

NIHR Clinical Research Network: Cancer
Pharmacyclics

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9943

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:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think