A trial looking into alemtuzumab and methylprednisolone for people with chronic lymphocytic leukaemia (CLL) with a p53 gene defect (UKCLL06 CAM-PRED)

Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)




Phase 2

This trial was looking to see how well the combination of alemtuzumab (Mabcampath) and methylprednisolone worked for chronic lymphocytic leukaemia.

Doctors often treat chronic lymphocytic leukaemia (CLL) with chemotherapy. Chemotherapy works very well for some people with CLL. But unfortunately it doesn’t always help.

A gene called p53 stops cells multiplying. It is called a 'tumour suppressor gene' because it stops cancers developing. It also helps chemotherapy drugs kill cancer cells if a cancer does develop.

The p53 gene is often damaged (mutated) or missing from cancer cells. Doctors know that cancer cells with a damaged or missing p53 gene are resistant Open a glossary item to certain chemotherapy drugs and the cancer may grow at a faster rate than usual. This makes it more difficult to treat.

Researchers know that there are 2 drugs that might help some people who have CLL with a damaged or missing p53 gene. These are methylprednisolone and alemtuzumab (MabCampath).

Methylprednisolone is a strong steroid drug. Alemtuzumab is a type of biological therapy, called a monoclonal antibody. You usually have methylprednisolone or alemtuzumab separately, but researchers thought these drugs might work better if you have them together.

The aim of this trial was to find out how well this combination of drugs worked for people with CLL who have a damaged or missing p53 gene.

Summary of results

The researchers found that the combination of alemtuzumab and methylprednisolone helped people with CLL that was difficult to treat.

The trial recruited 41 people. But sadly 2 people died before starting treatment.

Leukaemia responded to the drugs in more than 3 out of 4 people who did have treatment. In about 1 in 3 of the people treated, all signs of the leukaemia disappeared. Researchers call this a complete response Open a glossary item. The results were better for people who had not had any other treatment before going into the trial

Some side effects were about the same as they would be for people taking alemtuzumab alone, but some side effects were worse.

After having alemtuzumab and methylprednisolone, 8 people went on to have a transplant using bone marrow or stem cells from a donor.

The average length of time that the people in this trial lived after treatment was just under 2 years.

The researchers suggest that this drug combination helped people with CLL but may need to be improved.

We have based this summary on information from the team who ran the trial. The information has been reviewed independently (peer reviewed Open a glossary item) and published in a medical journal. 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 Andrew Pettitt

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Schering Healthcare Ltd

Other information

This is Cancer Research UK trial number CRUKE/05/021.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 605

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

Last reviewed:

Rate this page:

Currently rated: 4 out of 5 based on 1 vote
Thank you!
We've recently made some changes to the site, tell us what you think