“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial of chemotherapy with or without rituximab for chronic lymphocytic leukaemia
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This trial was to see if adding rituximab (Mabthera) to fludarabine, cyclophosphamide and mitoxantrone chemotherapy helped to improve treatment outcome for chronic lymphocytic leukaemia.
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
This phase 2 trial recruited 52 people. They were put into 2 groups by a computer. This is called
- 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 (
How to join a clinical trial
Professor Peter Hillmen
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
The Leeds Teaching Hospitals NHS Trust
This is Cancer Research UK trial number CRUKE/04/018.