A trial looking at treatment for people with newly diagnosed chronic lymphocytic leukaemia (ADMIRE)
Cancer type:
Status:
Phase:
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.
More about 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:
- if FCM-R was better than FCR for people with newly diagnosed CLL
- more about the side effects
Summary of results
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:
- 107 people were in the FCR group
- 108 people were in the FCM-R group
After treatment the team looked at how many people in each group had no sign of their leukaemia (a complete response). They found that:
- 60 out of the 107 people who had FCR had a complete response
- 65 out of the 108 people who had FCM-R had a complete response
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:
- 54 people who had FCR
- 47 people who had FCM-R
After an average follow up of 5 years the researchers found no significant difference between the 2 groups when they looked at:
- the number of people who were alive and had no sign of leukaemia
- the total number of people who were alive
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:
- 82 people (76.6%) in the FCR group
- 72 people (66.7%) in the FCM-R group
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.
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.
Chief Investigator
Professor Peter Hilmen
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Roche
The Leeds Teaching Hospitals NHS Trust
University of Leeds
Other information
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
