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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)

Overview

Cancer types:

Blood cancers, Chronic leukaemia, Chronic lymphocytic leukaemia (CLL), Leukaemia

Status:

Results

Phase:

Phase 2

Details

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 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: 1 May 2006

Recruitment end: 13 January 2008

How to join

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Chief investigators

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.

Last reviewed: 2 May 2013

CRUK internal database number: 605

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