A trial looking at chlorambucil alone, rituximab alone, or chlorambucil and rituximab together for MALT lymphoma (IELSG 19)

Cancer type:

Blood cancers
Low grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 3

This trial looked at chlorambucil and rituximab as treatment for MALT lymphoma. You may have either drug on its own, or both drugs together.

MALT stands for mucosa associated lymphoid tissue. MALT lymphoma is a low grade, B cell, non Hodgkin lymphoma (NHL). Doctors usually use a chemotherapy drug called chlorambucil to treat MALT lymphoma. This shrinks the lymphoma in most cases, but it doesn’t usually go away completely.

Doctors thought that a monoclonal antibody called rituximab may have been useful. Trials in some other types of lymphoma have shown that rituximab and chemotherapy work well together. But doctors were not sure how well rituximab would work for MALT lymphoma, either on its own, or with chemotherapy.

In this trial, some people had chlorambucil, some people had rituximab and some had both drugs. The aim of the trial was to find out which of these 3 treatments worked best.

Summary of results

In this trial the team wanted to compare 3 treatment groups to find out which was the best treatment for MALT lymphoma. The 3 groups were

  • Chlorambucil only
  • Chlorambucil and rituximab
  • Rituximab only

The team finished recruiting to the first 2 groups before they started recruiting to the rituximab only group. This summary covers the early results of this trial, comparing

  • Chlorambucil only
  • Chlorambucil and rituximab

The trial team found that adding rituximab to chlorambucil worked better than having chlorambucil on its own.

This was a phase 3 trial.  It was a randomised trial. The people taking part were put into treatment groups by a computer. Of the 252 people recruited, 227 had treatment as part of the trial

  • 113 people had chlorambucil only
  • 114 people had chlorambucil and rituximab

After treatment the team looked at the number of people whose lymphoma had responded to treatment. Of the 113 who had chlorambucil, they were able to look at 112 people. They found that for

  • 73 people there was no sign of their lymphoma – a complete response Open a glossary item
  • 25 people the lymphoma had shrunk – a partial response Open a glossary item
  • 8 people the lymphoma stayed the same – stable disease Open a glossary item
  • 6 people the lymphoma had got worse

Of the 114 who had chlorambucil and rituximab they were able to look at 111 people. They found that for

  • 89 people there was no sign of their lymphoma
  • 18 people the lymphoma had shrunk
  • 4 people the lymphoma got worse

After an average follow up of 5 years the team looked at the number of people who were alive and free of lymphoma

  • 62 out of every 100 people (62%) had chlorambucil only
  • 71 out of every 100 people (71%) had chlorambucil and rituximab

The trial team concluded that having chlorambucil and rituximab was better than chlorambucil only for MALT lymphoma.

When more results become available we will update this summary.

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

Professor Peter Johnson

Supported by

Experimental Cancer Medicine Centre (ECMC)
National Cancer Research Institute (NCRI)
National Institute for Health Research Cancer Research Network (NCRN)
University Hospital Southampton NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 373

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.”

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