A trial of lenalidomide and dexamethasone for chronic lymphocytic leukaemia that has got worse or come back after treatment (LenD)

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Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Leukaemia

Status:

Results

Phase:

Phase 2

This trial looked at low dose lenalidomide and the steroid dexamethasone for people who had already had treatment for chronic lymphocytic leukaemia (CLL).

More about this trial

In this trial, researchers wanted to see how well lenalidomide (Revlimid) and a steroid called dexamethasone worked for chronic lymphocytic leukaemia (CLL). The people taking part had already had between 2 and 9 courses of other treatment. But their leukaemia had come back or got worse.
 
The research team knew from other trials that lenalidomide may help people with CLL. But it can cause serious side effects. People in this trial started taking a low dose of lenalidomide with dexamethasone. The researchers hoped that giving dexamethasone would help reduce some of the side effects of lenalidomide, so it would be safe to gradually increase the dose during treatment.
 
The aims of the trial were to:
  • see how well the combination of dexamethasone and low dose lenalidomide works for people in this situation
  • learn more about the side effects

Summary of results

This trial showed that low dose lenalidomide and dexamethasone could be a useful treatment for some people with chronic lymphocytic leukaemia (CLL).
 
It recruited 12 people who had already had treatment for their CLL. Everyone taking part had lenalidomide and dexamethasone.
 
Of the 12 people who took part:
  • 4 people (33%) stopped treatment early because they had serious side effects
  • 4 people (33%) stopped treatment early because their CLL got worse
When the research team looked at how well the treatment worked, they found that the leukaemia had:
  • got a bit better in 3 people (25%)
  • stayed the same in 2 people (17%)
  • got worse in 7 people (58%)
They also looked at the side effects people had, and found that 11 out of 12 people had at least one severe side effect. The most common side effects were a drop in blood clotting cells (platelets) and a drop in white blood cells.
 
No one taking part had tumour lysis syndrome (TLS) or tumour flare reaction (TFR) Open a glossary item, two possible serious side effects of higher dose lenalidomide.
 
The research team had hoped to be able to increase the dose of lenalidomide people had. They increased the dose a bit for 5 of the people taking part. But they had to reduce it back down or delay treatment for most of them, because of side effects.
 
The researchers concluded that low dose lenalidomide and dexamethasone could be useful for people who have already had treatment for CLL that is not working anymore. But that it can cause serious side effects, even at a low dose, in this group of patients. Adding dexamethasone did mean that people had fewer side effects than expected. But not so few that they could change to a higher dose of lenalidomide.
 
They recommend that more research is done to find out which patients are likely to benefit most and have the least side effects.
 
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

Dr Amit C. Nathwani

Supported by

Celgene
NIHR Clinical Research Network: Cancer
University College London (UCL)

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Last review date

CRUK internal database number:

9311

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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