A trial looking at ofatumumab for chronic lymphocytic leukaemia

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Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Leukaemia

Status:

Results

Phase:

Phase 3

This trial compared a drug called ofatumumab with other standard treatments for chronic lymphocytic leukaemia.

It was for people who had:

  • leukaemia that had got worse or come back despite having fludarabine
  • swollen lymph nodes  Open a glossary item

More about this trial

Doctors can treat chronic lymphocytic leukaemia (CLL) with chemotherapy. One of the drugs they use is fludarabine. But sometimes the leukaemia gets worse or comes back after treatment.

Doctors are looking for ways to improve treatment for this group of people. In this trial, they looked at a drug called ofatumumab.

Ofatumumab is a type of targeted drug called a monoclonal antibody. It targets a particular protein on the surface of CLL cells. The ofatumumab sticks to the protein and helps the immune system Open a glossary item to recognise these cells and destroy them.

This trial compared ofatumumab with other standard treatments Open a glossary item a doctor could offer. They decided on the most suitable option for each person. For example, people might have had 1 of the following standard treatments:

  • chemotherapy
  • a targeted drug called alemtuzumab and a steroid Open a glossary itemdrug
  • a targeted drug called rituximab

The aims of the trial were to:

  • find out how well ofatumumab worked compared to standard treatments
  • find out how well long term ofatumumab worked
  • learn more about the side effects

Summary of results

The researchers found that ofatumumab didn’t work better than standard treatments for this group of people. But in those who went on to have long term ofatumumab, it did seem to help.

This was a phase 3 trial. The researchers published the results in 2016.

Treatment
122 people joined the trial. They were 2 times more likely to have ofatumumab than standard treatment.

Everyone was put into 1 of 2 groups at random, and:

  • 79 had ofatumumab (group 1)
  • 43 had standard treatments (group 2)

People who had standard treatment (group 2) could go on to have ofatumumab if their leukaemia got worse. A total of 22 people in this group went on to have ofatumumab.

In people who had ofatumumab (group 1), 37 people’s leukaemia hadn’t got worse when they finished treatment. They were then put into 1 of 2 groups at random, and:

  • 24 had ofatumumab for a further 6 months (long term treatment)
  • 13 didn’t have further ofatumumab

Results
The researchers compared ofatumumab with standard treatment. They looked at the average length of time people lived:

  • without their leukaemia getting worse
  • after treatment (overall survival)

They found no difference in either of these.

Long term ofatumumab
The researchers also looked at how well treatment worked in people who went on to have long term treatment with ofatumumab. This is the group who went on to have a further 6 months of treatment.

They looked at the average length of time people lived without their leukaemia getting worse. Not unsurprisingly, this was a bit better in patients who had more treatment. It was:

  • 5.6 months in people who had ofatumumab
  • 3.5 months in people who had no further treatment

However, there was no significant difference in the average length of time people lived after treatment. This is called overall survival and this was

  • 25.4 months in people who had ofatumumab
  • 17.8 months in people who had no further treatment

Side effects
The side effects in people who had ofatumumab compared with standard treatments were similar.

The most common included:

  • an increased risk of infection
  • pneumonia
  • tiredness and breathlessness (anaemia)
  • a serious complication of an infection (sepsis)

They didn’t find any extra side effects in those who had long term ofatumumab.

Conclusion
The trial team concluded that ofatumumab didn’t improve the length of time before the leukaemia got worse compared with standard treatment. When given long term, it did seem to lengthen the time it takes for the CLL to recur compared to people who didn’t have more treatment. However, ofatumumab did not change the overall survival.

So, the researchers suggest it might be worth looking at ofatumumab as a long term treatment (maintenance treatment) option for people who have had a lot of treatment for CLL in the past.

We have based this summary on information from the research team. 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 trial team who did the research. 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

Dr Anna Schuh

Supported by

Genmab
GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer

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Last review date

CRUK internal database number:

8234

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

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