A trial looking at lenalidomide for B cell chronic lymphocytic leukaemia (CLL 009)

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Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Leukaemia

Status:

Results

Phase:

Phase 2

This trial looked at lenalidomide for B cell chronic lymphocytic leukaemia (CLL) that had come back or not responded to treatment. 

More about this trial

Doctors often treat chronic lymphocytic leukaemia (CLL) with chemotherapy. But sometimes the leukaemia does not respond to treatment (it is refractory). Or the leukaemia comes back after treatment (it relapses).
 
Lenalidomide (Revlimid) is a treatment that affects how the immune system works. We already knew from research that lenalidomide may help people with B cell CLL that had come back or not responded to treatment. But the researchers were not sure about the best dose to use at the beginning of treatment. 
 
In this trial people started treatment at different doses. The aim was to gradually increase the dose for everyone, until they were all having the same maximum dose.
 
The aims of this trial were to:
  • find out how well people were able to cope with different starting doses of lenalidomide
  • find out how well different doses of lenalidomide work for B cell CLL

Summary of results

The research team found that the starting dose of lenalidomide didn’t make much difference to how well it worked, or the side effects people had. But they found it worked better for those who went on to have a higher dose. 
 
They recruited people between 2010 and 2012, and reported the results in 2016.
 
Results
This trial recruited 104 people with chronic lymphocytic leukaemia (CLL) that had come back or not responded to treatment. 
 
People taking part took lenalidomide capsules once a day, every day. They were put into 1 of 3 groups at random. The people in different groups took different doses of lenalidomide to begin with:
  • 34 people started treatment with 5mg of lenalidomide each day
  • 35 people started treatment with 10mg of lenalidomide each day
  • 35 people started treatment with 15mg of lenalidomide each day
If they didn’t have any serious side effects the dose was increased every 4 weeks (28 days), up to the maximum dose of 25mg each day.
 
The research team looked at how well the treatment worked. They found that the leukaemia had gone away in 8 people (8%) and got a bit better in 34 people (33%). The number of people who responded to treatment was similar in the different groups. 
 
When they looked at how long it was before the leukaemia started to grow, they found it was 89 weeks.  This was also similar across the 3 groups. 
 
They also analysed how well people did depending on the highest dose they took. The results showed that people who were able to have a higher dose and took up to 20 or 25mg each day did better than those who needed to stay on a lower dose. 
 
They looked at how long it was before the leukaemia started to grow again, and it was about:
  • 3 months for people who did not have an increase in dose above 5 or 10mg each day
  • I year and 8 months for people who had an increase in dose to at least 15mg each day
  • 2 years and 2 months for people who had an increase in dose to at least 20mg each day
  • 2 years and 4 months for people who had an increase in dose to the maximum of 25mg each day
They also found that people who started at the lower doses were able to cope with increasing doses without too many problems.
 
Side effects
People taking part did have some side effects, but most people coped well with treatment. The number of people who had side effects was similar in the 3 groups.
 
The most common side effects of lenalidomide across all the groups were:
  • a drop in white blood cells, blood clotting cells (platelets) and red blood cells
  • tiredness (fatigue)
Lenalidomide can sometimes cause a temporary increase in symptoms. This is called tumour flare reaction (TRF). This happened in 64 people who took part, but it was mostly mild or short term. It was a bit more serious in 15 people.
 
It can also cause a rare condition called tumour lysis syndrome (TLS). This is when a lot of leukaemia cells are broken down and products of the break down are released into the blood stream. This can change the levels of certain chemicals in the blood, which can cause problems. This only happened in 5 people who took part in this trial.
 
Conclusion
The research team concluded that how well lenalidomide worked, and the side effects it caused, were similar across the 3 groups. They were not able to say which dose would be best to use at the start of treatment. But the results did show that lenalidomide worked better for people who were able to increase to a higher dose.
 
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

Celgene Corporation
Experimental Cancer Medicine Centre (ECMC)

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Last review date

CRUK internal database number:

Oracle 5889

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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