A trial of alemtuzumab after chemotherapy for chronic lymphocytic leukaemia - CLL207 MRD Eradication Study

Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Leukaemia

Status:

Results

Phase:

Phase 2

This trial used alemtuzumab (Mabcampath) to reduce the small number of leukaemia cells left in the blood after treatment for chronic lymphocytic leukaemia.

More about this trial

Chemotherapy is often used to treat chronic lymphocytic leukaemia (CLL). But unfortunately there are sometimes a small number of leukaemia cells still in the blood after the treatment has finished. This is minimal residual disease (MRD). Your leukaemia will come back (recur) if these cells start to grow again.

Alemtuzumab is a type of targeted cancer drug (a biological therapy) called a monoclonal antibody. Some people with CLL who have not responded to treatment with chemotherapy have this drug.

In this trial people who still had a small number of leukaemia cells left after chemotherapy (MRD positive) had alemtuzumab. And people also had alemtuzumab if they became MRD positive again later on. The people who remained MRD positive were monitored as part of the study. 

The main aim of this trial was to find how well alemtuzumab worked for people who are MRD positive. 

Summary of results

The trial team concluded that alemtuzumab worked for people who were MRD positive but it had significant side effects.

This was a phase 2 trial.

This main trial was open to people who had chemotherapy for their CLL and a blood test showed there were some leukaemia cells left (MRD positive).

In total, 47 people in took part in the main trial. Everyone started treatment with alemtuzumab. With 41 people receiving the full 6 weeks of treatment.

After treatment they had a bone marrow test and another blood test. The team looked at the results to see if there was any leukaemia cells left in the bone marrow or the blood. They found that:

  • 39 people had no leukaemia cells - they were MRD negative
  • 7 people had leukaemia cells – they were MRD positive

One person was too ill to have the bone marrow test or blood test.

The same tests were done 6 months after finishing treatment. Of the 39 people who were MRD negative immediately after treatment, 18 people were still MRD negative 6 months later. The average length of time these 18 people stayed MRD negative was just under 4 years.

Researchers noted that those who stayed MRD negative for more than 6 months after treatment appeared to have a greater chance of staying MRD negative.

The team looked at the total number of people who didn’t have any sign of their leukaemia 5 years after treatment. They found it was 25 people (53.2%).

They also looked at the total number of people who were alive after 5 years. They found it was 34 people (72.3%).

The most common reported side effects of alemtuzumab were:

  • skin rash
  • a drop in blood cells
  • tiredness
  • breathing problems
  • high temperature (fever)

In addition, 15 people who were already MRD negative at the start of the trial were monitored alongside the main trial. It was found that the average length of time they stayed MRD negative, was similar to the people who were MRD negative at 6 months in the main trial.

The trial team concluded that this trial suggests that alemtuzumab can improve the outcome of people who were MRD positive after chemotherapy. But the side effects are bad. The team are now looking into another targeted cancer drug for people who are MRD positive after having chemotherapy. The drug is like alemtuzumab but with less severe side effects.   

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 Hillmen

Supported by

Leeds Institute of Clinical Trials Research, University of Leeds
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Genzyme Therapeutics
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUKE/06/038.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

826

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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