
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
This trial looked at standard chemotherapy and rituximab with or without mitoxantrone for people with newly diagnosed chronic lymphocytic leukaemia (CLL).
Cancer Research UK supported this trial.
Doctors usually treat CLL with 2 chemotherapy drugs called fludarabine and cyclophosphamide in combination with a targeted cancer drug (a biological therapy) called rituximab. Doctors call this combination FCR.
Earlier trials suggested that adding a chemotherapy drug called mitoxantrone to FCR might be a useful treatment for CLL. Doctors call this combination FCM-R.
The doctors in this trial thought that this combination would help to lower the number of leukaemia cells that can be left behind after treatment. Remaining cancer cells are called ‘minimum residual disease’ or MRD. An undetectable MRD level means the leukaemia is less likely to come back.
The aims of this trial were to find:
The team found that FCM-R wasn’t better than FCR for people with newly diagnosed CLL.
This was a phase 2 trial. It was a randomised trial. The 215 people who took part were put into 1 of 2 treatment groups by a computer. Neither they or their doctor chose which group they were in:
After treatment the team looked at how many people in each group had no sign of their leukaemia (a complete response). They found that:
3 months after finishing treatment everyone had a bone marrow test. This was to assess the minimum residual disease (MRD) in each group. They found that there was a very small amount or no MRD in:
After an average follow up of 5 years the researchers found no significant difference between the 2 groups when they looked at:
The side effects of FCR and FCM-R were similar. The worst side effects people had were infections.
Some people in both groups didn’t complete their treatment because side effects were too bad. The number who competed their treatment was:
The trial team concluded that adding mitoxantrone to FCR (FCM-R) didn’t improve the response rate of chronic lymphocytic leukaemia in newly diagnosed people. FCR remains the for these people.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists () and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Peter Hilmen
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Roche
The Leeds Teaching Hospitals NHS Trust
University of Leeds
This is Cancer Research UK trial number CRUKE/09/016.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.