A trial looking at treatment for people with newly diagnosed chronic lymphocytic leukaemia (ADMIRE)

Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Leukaemia

Status:

Results

Phase:

Phase 2

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

ADMIRE trial diagram

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 standard treatment Open a glossary item 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 (peer reviewed Open a glossary item) 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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

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.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

4269

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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