A trial looking at CVP with or without rituximab for advanced follicular lymphoma

Cancer type:

Blood cancers
Low grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 3

This trial compared rituximab and a combination of chemotherapy called CVP with CVP alone for advanced follicular lymphoma. It recruited people who had not had treatment for advanced lymphoma before.

Follicular lymphoma is the most common type of non Hodgkin lymphoma (NHL). Doctors often treat advanced follicular lymphoma with CVP.  CVP is cyclophosphamide, vincristine and the steroid prednisolone.

Rituximab (Mabthera) is a type of biological therapy called a monoclonal antibody. Before this trial was done, earlier studies showed that it may be a useful treatment for follicular lymphoma. In this trial, doctors wanted to see how well CVP and rituximab worked together in treating advanced follicular lymphoma.

The aims of the trial were to find out

  • If rituximab and CVP is better than CVP alone for advanced follicular lymphoma
  • More about the side effects

Summary of results

The trial team found that rituximab and CVP together is a useful treatment for people with advanced follicular lymphoma.

The trial recruited 322 people

  • Half had CVP alone
  • Half had CVP and rituximab

The researchers analysed the early results in 2004. They looked at how well people responded to treatment about 6 weeks after it finished. They found that around 8 in 10 people (81%) who had CVP with rituximab had lymphoma that either improved or disappeared. This compared to around 6 in 10 people (57%) who had CVP alone.

About 2 ½ years after treatment finished, the researchers looked at people whose lymphoma had continued to grow. On average, CVP and rituximab controlled the lymphoma for about 2 ½ years. This compared with 1 ½ years for CVP alone.

Side effects were quite similar in both treatment groups. But more people who had CVP and rituximab had problems with a drop in white blood cells. And a few had a mild or moderate allergic reaction to rituximab.

The researchers continued to follow up the people who took part in the trial to study differences in long term survival between the 2 groups. They analysed these results in 2008. They found the number of people alive 4 years after treatment was higher in the group who had CVP and rituximab (83%) compared to those who had CVP alone (77%).

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 R Marcus

Supported by

Roche

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 174

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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