A trial of chemotherapy with or without rituximab for chronic lymphocytic leukaemia

Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Leukaemia

Status:

Results

Phase:

Phase 2

This trial was to see if adding rituximab (Mabthera) to fludarabine, cyclophosphamide and mitoxantrone chemotherapy helped to improve treatment outcome for chronic lymphocytic leukaemia.

Doctors often treat chronic lymphocytic leukaemia (CLL) with chemotherapy. But unfortunately it doesn't always work very well, and the CLL begins to grow again.

Fludarabine, cyclophosphamide and mitoxantrone are chemotherapy drugs used to treat CLL that has come back. Doctors thought that giving a monoclonal antibody called rituximab (Mabthera) as well as chemotherapy may be useful. But they didn’t know how well this combination of treatment would work for CLL.

This trial looked at fludarabine, cyclophosphamide, and mitoxantrone with or without rituximab. The aim of the trial was to see which combination of treatment was better for CLL that had either not responded to treatment, or had come back after treatment.

Summary of results

The trial team found that adding rituximab to fludarabine, cyclophosphamide and mitoxantrone increased the number of people who had a complete response to treatment.

This phase 2 trial recruited 52 people. They were put into 2 groups by a computer. This is called randomisation.

  • 26 people had fludarabine, cyclophosphamide and mitoxantrone (FCM)
  • 26 had the same chemotherapy, with the addition of rituximab (FCM-R)

When the researchers looked at the number of people whose CLL had gone away (complete response), they found it was

  • 4 people in the FCM group
  • 11 people in the FCM-R group

Even when leukaemia responds to treatment, very small numbers of leukaemia cells can be left behind. Doctors call this minimal residual disease (MRD). The researchers looked at the number of people who did not have any minimal residual disease 2 months after treatment. They found this was

  • 3 people in the FCM group
  • 5 people in the FCM-R group

The trial team concluded that adding rituximab to fludarabine, cyclophosphamide and mitoxantrone improved the response rate without causing any extra side effects. They suggest this should be looked at in larger trials.

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) 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 Hillmen

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Roche
The Leeds Teaching Hospitals NHS Trust

Other information

This is Cancer Research UK trial number CRUKE/04/018.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 545

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

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

Last reviewed:

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