A trial comparing standard treatment with newer treatments for people with chronic lymphocytic leukaemia (CLL4)

Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)




Phase 3

This trial compared chlorambucil alone with fludarabine alone and fludarabine with cyclophosphamide for chronic lymphocytic leukaemia (CLL).

Doctors usually treat CLL with chlorambucil. Results from earlier clinical trials showed that a newer drug called fludarabine might be useful for treating CLL. Doctors also wanted to see if fludarabine in combination with cyclophosphamide is a helpful treatment or not.

The aims of the trial were to find out

  • Which of the 3 treatments works best for people who have not had treatment for their CLL before
  • More about the side effects and quality of life

Summary of results

The researchers found that fludarabine and cyclophosphamide together is a more useful treatment combination for CLL than chlorambucil alone or fludarabine alone.

777 people with CLL took part in the trial. About

  • Half had clorambucil alone
  • A quarter had fludarabine alone
  • A quarter had fludarabine and cyclophosphamide

The researchers analysed the results in 2007. They looked at how well people responded to treatment. They found that more people in the fludarabine and cyclophosphamide group had CLL that had either stayed the same or improved.

They also looked at the number of people who were alive 5 years after treatment. There was a small difference between the groups, but not enough to be significant in statistical terms Open a glossary item.

People in the cyclophosphamide and fludarabine group had more problems with a drop in white blood cells (neutropeania) and spent more days in hospital as a result. The trial team say they have not yet finished analysing the quality of life questionnaires completed by the patients who took part in the trial.

The researchers compared the results of this trial with the results of other, similar trials (a meta-analysis). They concluded from this detailed analysis that fludarabine and cyclophosphamide together, should become the new standard treatment in the future for people with CLL.

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 D Catovsky

Supported by

Leukaemia and Lymphoma Research
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
Schering AG
Schering Healthcare Ltd

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 55

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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