A trial looking at rituximab and high dose chemotherapy for follicular lymphoma that has come back or is proving hard to treat

Cancer type:

Blood cancers
Low grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 3

This trial looked at rituximab (Mabthera) before and after high dose chemotherapy Open a glossary item for follicular lymphoma.

Follicular NHL is a type of low grade non Hodgkin lymphoma. It is usually possible to control this type of lymphoma for a number of years, but it is difficult to cure. It is usually treated with chemotherapy to get it into remission Open a glossary item. This means there is no sign of the disease, but it is still there and is likely to come back at some time in the future. Some follicular lymphomas do not go into a full remission, but may have what doctors call a 'very good partial remission'.

Doctors have been trying to improve the outlook for people with follicular lymphoma by using high dose chemotherapy. But there is still a risk that the disease will come back because there may still be lymphoma cells left in the body when the disease is in remission.

The aim of this trial was to see if treatment with rituximab before and after high dose therapy improved the outlook for follicular lymphoma by ridding the body of more lymphoma cells and keeping the disease in remission for longer.

Summary of results

The trial team found that having rituximab after high dose chemotherapy is safe and significantly increased the amount of time it took before follicular lymphoma started to come back.   

This was a phase 3 trial. It recruited 280 people. It was a randomised trial. The people taking part were put into 1 of 4 treatment groups by a computer

  • 69 people had rituximab before and after high dose therapy
  • 72 people had rituximab before high dose therapy only
  • 69 people had rituximab after high dose therapy only
  • 70 people had high dose therapy only

Of the 280 recruited, the trial team were able to look at the results of 200 people.

After an average follow up of just under 8½ years, the researchers looked at how many people were alive and free of cancer. Of those free of cancer, they found that

  • 48 out of every 100 people (48%) had rituximab before high dose therapy
  • 42 out of every 100 people (42%) didn’t have rituximab before high dose therapy
  • 54 out of every 100 people (54%) had rituximab after high dose therapy
  • 37 out of every 100 people (37%) didn’t have rituximab after high dose therapy

They also found that having rituximab didn’t make a difference to the total number of people who were still alive.  

The most common side effects reported were

The trial team concluded that having rituximab after high dose therapy was safe and did significantly increase the amount of time it took for follicular lymphoma to come back.  

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 trial 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

Dr Ruth Pettengell
Professor A.H. Goldstone

Supported by

European Foundation for Blood and Marrow Transplantation (EBMT)
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 95

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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