A study of lenalidomide for acute myeloid leukaemia or high risk myelodysplastic syndrome in people who have an abnormality in chromosome 5 (Len5)

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers
Myelodysplastic syndrome (MDS)




Phase 2

This study looked at lenalidomide (Revlimid) on its own and in combination with chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome in people who had changes to a particular chromosome (a ‘chromosomal abnormality’). This trial was supported by Cancer Research UK.

The first treatment for acute myeloid leukaemia (AML) is usually chemotherapy. The first phase of treatment is called ‘remission induction’ and aims to get rid of all signs of the leukaemia. But this type of chemotherapy can cause serious side effects. So researchers were looking for treatments that could target the leukaemia cells but cause fewer side effects.

Myelodysplastic syndrome (MDS) Open a glossary item is a condition affecting the bone marrow Open a glossary item. If you have MDS, your bone marrow makes abnormal blood cells, but not enough healthy blood cells. MDS can sometimes develop into leukaemia. If you have a lot of abnormal cells in your bone marrow, there is a higher risk of the MDS becoming leukaemia. You may hear this called high risk MDS. The only treatment that can cure MDS is a stem cell transplant. But some people don’t have a donor and this is an intensive treatment with a lot of side effects.

More than 1 in 10 people (11%) with AML have an abnormality on chromosome Open a glossary item 5 – part or all of the chromosome is missing. Some people with high risk MDS have this abnormality too.

Lenalidomide is a type of biological therapy. It works mainly by helping the body’s immune system Open a glossary item target cancer cells. We know from earlier research that lenalidomide can help people with low risk MDS where chromosome 5 is missing. Researchers thought it might help people with high risk MDS or AML who have a chromosome 5 abnormality. The aims of this study were to

  • See if it was safe to have lenalidomide on its own or with chemotherapy for AML or high risk MDS
  • Learn more about the side effects
  • Find out if it helped people with AML or high risk MDS

Summary of results

The trial team found that induction treatment with lenalidomide on its own didn’t work for people with AML or high risk MDS.

This was a phase 2 trial.

Everyone had lenalidomide tablets every day for 3 weeks followed by a week of no treatment. This 4 week period is called a cycle of treatment. They then had a bone marrow test to find out how well their AML or MDS had responded to treatment.

Depending on the results of the bone marrow tests they then

  • Continued with lenalidomide
  • Had 2 more cycles of lenalidomide followed by a stem cell transplant from a donor
  • Had lenalidomide with chemotherapy followed by a stem cell transplant from a donor

Of the 14 people recruited

  • 1 person continued with lenalidomide
  • 9 people had lenalidomide and chemotherapy
  • 4 people unfortunately died

Of the 9 people who had lenalidomide and chemotherapy, 2 had a stem cell transplant and 7 unfortunately died.

The most common side effects of lenalidomide and chemotherapy were

The trial team concluded that having lenalidomide alone as an induction treatment for AML or high risk MDS didn’t work.  

We have based this summary on information from the team who ran the trial. 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. 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 David Bowen

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Leeds Institute of Clinical Trials Research (University of Leeds)
Leeds Teaching Hospitals NHS Trust
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/08/026.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 3489

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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