A trial looking at chemotherapy for Waldenstrom's macroglobulinaemia or lymphoma of the spleen (WM1)

Cancer type:

Blood cancers
Low grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 3

This trial compared chlorambucil with fludarabine chemotherapy for Waldenstrom's macroglobulinaemia or lymphoma of the spleen.

Doctors treat Waldenstrom’s macroglobulinaemia or lymphoma of the spleen with chemotherapy. Fludarabine and chlorambucil are drugs that are commonly used. Doctors knew that both drugs worked but wanted to find out which drug worked the best.

This trial compared them to find out which was better and more about their side effects.

Summary of results

The trial team found that fludarabine was better than chlorambucil to treat Waldenstrom’s macroglobulinaemia or lymphoma of the spleen.

This was a phase 3 trial. It recruited 414 people. It was a randomised trial. Half the people had fludarabine and the other half had chlorambucil.

When the researchers looked at the number of people whose lymphoma responded to treatment they found that

  • 53 out of every 100 people (53%) had fludarabine
  • 43 out of every 100 people (43%) had chlorambucil

The average time people were free of their lymphoma was

  • 3 years for those who had fludarabine
  • Just over 2 years for those who had chlorambucil

5 years after treatment, the team looked at how many people were alive. They found that

  • 62 out of every 100 (62%) had chlorambucil
  • 70 out of every 100 (70%) had fludarabine

The worst side effect for both fludarabine and chlorambucil was a drop in blood cells.

The trial team concluded that fludarabine was better than chlorambucil to treat Waldenstrom’s macroglobulinaemia or lymphoma of the spleen.

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 Roger G Owen

Supported by

NIHR Clinical Research Network: Cancer
Taunton and Somerset NHS Trust

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 561

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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