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

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 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.

Recruitment

Start 01/05/2006
End 13/01/2008

Phase

Phase 2

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. 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) and published in a medical journal. We have not analysed the data ourselves.

Chief Investigator

Professor Andrew Pettitt

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

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Schering Healthcare Ltd
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Updated: 3 May 2013