A trial looking at treatment for high risk chronic lymphocytic leukaemia (CLL 210)

Cancer type:

Blood cancers

Chronic leukaemia

Chronic lymphocytic leukaemia (CLL)

Leukaemia

Status:

Results

Phase:

Phase 2

This trial was for people with chronic lymphocytic leukaemia (CLL) who had a high risk of their leukaemia coming back.

Cancer Research UK supported this trial.

More about this trial

Doctors often treat chronic lymphocytic leukaemia (CLL) with chemotherapy or targeted drugs. Your treatment has worked well if there is no sign of the leukaemia (it has gone into remission) Open a glossary item

. But sometimes it doesn’t work very well and doctors are keen to improve treatment so that more people go into remission.

Some leukaemia cells have a faulty (mutated) or missing gene called p53 Open a glossary item

. If the cells have this fault, the leukaemia is classed as high risk.

The trial was looking at a combination drugs for induction therapy. The aim of induction therapy is for the leukaemia to go into remission.

Before the 11th September 2012, those taking part had a combination of drugs known as CamDexRev. This included:

alemtuzumab (MabCampath) - a type of drug called a monoclonal antibody
dexamethasone - a steroid
lenalidomide (Revlimid) - a drug that affects how the immune system works

After September 2012, the trial team decided to replace alemtuzumab with another type of monoclonal antibody called ofatumumab. This was because it became difficult to get alemtuzumab from the manufacturers.

This summary is about the results of those people who had treatment with CamDexRev (alemtuzumab,dexamethasone and lenalidomide).

The trial also looked at the longer term use of lenalidomide as a maintenance therapy. The aim of maintenance therapy is for the leukaemia to stay in remission for as long as possible.

The aims of this trial were to find out:

how well CamDexRev worked as induction and maintenance therapy for high risk CLL
more about the side effects
how these treatments affected quality of life

Summary of results

Please note this summary is about the results of those people who had induction therapy with alemtuzumab, dexamethasone and lenalidomide (CamDexRev).

A smaller number of people were recruited to this part of the trial than expected. So the trial team were not able to come to any firm conclusions. But they thought that this combination of drugs was a treatment that worked and was safe.

Those people who took part in this trial after September, 2012 had induction treatment with ofatumumab (Arzerra), dexamethasone and lenalidomide.

We hope to include the results for this group of people when they become available.

Induction therapy

This was a phase 2 trial. Planned treatment was as follows:

6 months of induction therapy
stem cell or bone marrow transplant for those who were suitable
randomisation into maintenance treatment for people whose induction treatment had gone well, but were not suitable for a transplant

Sixteen people had induction therapy with:

Of these 16 people, 10 people completed 6 months of induction therapy. Other people didn’t finish their induction therapy for various reasons. For example, the side effects were too severe, or their leukaemia got worse (relapsed Open a glossary item

Following induction therapy, the researchers looked at how well treatment had worked. Out of the 10 people the leukaemia:

was well controlled in 8 people (partial remission)
was very well controlled in 2 people (complete remission)

Three of the 10 people then had a stem cell transplant. They stopped taking part in this trial before they had their transplant.

Maintenance therapy

The trial doctors then discussed maintenance therapy using lenalidomide with the other 7 patients.

This part of the trial was randomised. This means the people taking part were put into 1 of 2 treatment groups by a computer. Neither they nor their doctor chose which group they were in.

Out of the 5 people who agreed to take part in the lenalidomide randomisation:

3 people had lenalidomide capsules every day
2 people had no further treatment

Those who had lenalidomide continued treatment for as long as it was controlling their leukaemia.

Out of the 3 people who have maintenance therapy using lenalidomide:

1 person’s leukaemia was still under control (in remission) after 2 years
1 person stopped lenalidomide after 2 months because their leukaemia started to grow again (relapse)
1 person stopped lenalidomide after 3 months to have a transplant

The researchers looked at the time it took for the leukaemia to come back (relapse) in all those taking part. They were able to record this in 15 of the 16 patients. On average it was just under 2 ½ years.

The most common side effects reported with induction therapy included:

a drop in blood cells causing an increased risk of infection such as chest infection
a drop in blood cells causing an increased risk of tiredness and breathlessness (anaemia )
a drop in blood cells causing an increased risk of bleeding problems
build up of fluid in the legs (oedema)

The trial team continued to see people at regular appointments for just under 4 years. They asked people about their side effects. 14 of the 16 patients had at least one severe side effects during this time.

Recruitment start:

06/02/2012

Recruitment end:

31/10/2015

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.

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Chief Investigator

Prof A Pettitt

Supported by

Baxter Ltd
Cancer Research UK
Cancer Research UK Liverpool Cancer Trials Unit (LCTU)
Celgene Ltd
Chugai Pharmaceutical Co Ltd
GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer
Royal Liverpool and Broadgreen University Hospital NHS Trust
University of Liverpool