A trial of azacitidine and lenalidomide for acute myeloid leukaemia or myelodysplasia that has come back after a stem cell transplant (VIOLA)

Cancer type:

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




Phase 1

This trial is looking at the drugs azacitidine and lenalidomide for acute myeloid leukaemia or myelodysplasia that has come back after a stem cell transplant using cells from a donor.

Doctors can treat acute myeloid leukaemia (AML) or myelodysplasia (MDS) with high doses of chemotherapy, followed by a stem cell transplant using cells from a donor (an allogeneic transplant Open a glossary item).

But AML and MDS can come back after a transplant and are then much more difficult to treat. Researchers are looking for new treatments to help people in this situation. In this trial they are looking at 2 drugs called azacitidine and lenalidomide.

Azacitidine is already used to treat AML and MDS. It works by blocking the action of a protein which leukaemia cells need to stay alive.

Lenalidomide affects the way the immune system works. But we don’t know exactly how it works yet.

The aims of the trial are to

  • Find the highest dose of lenalidomide you can have safely with azacitidine
  • Learn more about the side effects of this drug combination
  • See if the treatment helps people with AML or MDS that has come back after a stem cell transplant

Who can enter

You may be able to join this trial if all of the following apply. You

You cannot join this trial if any of these apply. You

  • Have (or have had) a condition called graft versus host disease after your transplant, unless it is only mild (the trial team can advise you about this)
  • Have problems with your liver or kidneys
  • Have had any other cancer treatment (including experimental treatments) in the last 4 weeks
  • Have an active infection that is causing symptoms
  • Can’t have azacitidine or lenalidomide for some reason
  • Have any other medical condition that the trial team think could affect your taking part
  • Are pregnant or breastfeeding

Trial design

This is a phase 1 trial. The researchers need about 30 people to join. Everybody taking part has azacitidine and lenalidomide.

The researchers are testing 7 different doses of lenalidomide. The dose you have will depend on when you join the trial.

You have azacitidine as injections just under your skin. You take lenalidomide capsules by mouth.

Your treatment will be in 6 week periods called cycles of treatment.

In each cycle of treatment you have

  • Azacitidine injections on 7 days
  • Lenalidomide capsules each day for 3 weeks, starting the day after you finish having azacitidine

You have 6 cycles of treatment lasting about 9 months all together. But if it is helping and you don’t have bad side effects, the trial team may talk to you about having the trial treatment for longer.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

You see the trial team and have regular blood tests throughout the trial. You have a bone marrow test after the 3rd and 6th cycles of treatment. It is also possible that the trial team will want you to have more bone marrow tests.

At the beginning of each cycle of treatment, you go to hospital 7 times to have the azacitidine injections. Each visit will last between 1 and 3 hours. Depending on where you are having your treatment, it may be possible for a nurse to come and give your injections at home.

When you finish treatment, you see the trial team and have some blood tests 4 weeks later. The trial team will also check how you are after a year.

Side effects

Having azacitidine and lenalidomide together is an experimental treatment and there may be side effects we don’t know about yet.

The most common side effects of azacitidine include

The most common side effects of lenalidomide include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Blurred vision
  • Diarrhoea or constipation
  • Pain including in your chest, joints and muscles
  • Feeling or being sick
  • Feeling tired, weak or unwell
  • High temperature (fever)
  • Chest infection (pneumonia) and other infections
  • Sore throat
  • Stuffy nose
  • Weight loss
  • Loss of appetite and taste changes
  • Changes to the balance of chemicals in your blood
  • Dizziness
  • Headache
  • Changes to your sense of touch
  • Shaking
  • Cough
  • Blood clots
  • Dry skin and itching
  • An allergic reactions

The trial team will talk to you about all the possible side effects before you agree to take part.



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 Charles Craddock

Supported by

Cancer Research UK Clinical Trials Unit - Birmingham
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


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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