A trial comparing rituximab with `watch and wait' for advanced follicular lymphoma

Cancer type:

Blood cancers

Low grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 3

This trial was comparing rituximab (Mabthera) with 'watch and wait' for people with follicular lymphoma who didn't have symptoms. This trial was supported by Cancer Research UK.

More about this trial

Follicular lymphoma is a common type of non Hodgkin lymphoma (NHL) and is generally classed as a low grade lymphoma. This means that the lymphoma usually grows quite slowly, over a number of years.

If you have low grade follicular lymphoma, you may not have treatment as soon as you are diagnosed. Your doctor may keep an eye on you. This is sometimes called ‘watchful waiting’ or ‘watch and wait’. You doctor may recommend you start chemotherapy if your lymphoma starts to grow more quickly, or if you feel less well.

Rituximab is a type of biological therapy called a monoclonal antibody. It is already used to treat some people with low grade lymphoma, alongside chemotherapy.

This trial was trying to find out if having immediate treatment with rituximab on its own could delay the time until you need to start other chemotherapy.

Summary of results

The trial recruited 463 people who had been diagnosed with follicular lymphoma but did not have any symptoms. It was a randomised trial, so the people taking part were put into 1 of 3 treatment groups by computer. Neither they, nor their doctors could choose which group they were in:

people in group A had no treatment (watch and wait)
people in group B had rituximab once a week for 4 weeks
people in group C had rituximab once a week for 4 weeks, then once every 2 months for 2 years

When the trial had been running for 3 years, it stopped recruiting people into group B because other studies had shown that having rituximab for longer helped people more.

The trial team looked at how many people had still not started other treatment 3 years after joining the trial. They found this was:

just under half (48%) of the people in group A
8 out of 10 people (80%) in group B
more than 9 out of 10 people (91%) in group C

The side effects of rituximab included a drop in the number of white blood cells, sometimes leading to infections, and 5 people had an allergic reaction to the drug.

The researchers presented these results at a conference in December 2010. At this time, the results did not show that rituximab helped the people in this trial to live longer, but it did delay the time until they needed to start other treatment. So the researchers suggest rituximab could become a treatment for people when they are first diagnosed with follicular lymphoma, even if they don’t have symptoms.

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 ) but may not have been published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.