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:
Status:
Phase:
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.
More about this trial
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.
is a condition affecting the . 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 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 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
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Tiredness
- Liver changes
- Feeling or being sick
- Nerve changes
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 () 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.
Chief Investigator
Professor David Bowen
Supported by
Cancer Research UK
Celgene
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.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
