A trial looking at azacitidine for acute myeloid leukaemia or myelodysplasia (AMADEUS)

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Cancer type:

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

Status:

Open

This trial is looking at having a drug called azacitidine after a stem cell transplant. 

It is for people who are having a stem cell transplant Open a glossary item with somebody else’s cells. This is called an allogeneic transplant Open a glossary item

More about this trial

Chemotherapy is the usual treatment for acute myeloid leukaemia (AML) and high risk myelodysplastic syndrome (MDS)

MDS blood cells have changes in them that make them develop abnormal cells. They might not need treatment for many years, but some go on to develop into acute myeloid leukaemia (AML). High risk MDS means there is more chance it might develop into AML over time. High risk MDS is treated in a similar way to AML. 

After chemotherapy some people go on to have a stem cell transplant. But sometimes the leukaemia comes back. So researchers are looking for ways to improve treatment. They know from research that having treatment after a transplant in some blood cancers reduces the risk of the leukaemia coming back. 

In this trial, they are looking at a drug called azacitidine. It is already a treatment for AML in people who can’t have chemotherapy and a stem cell transplant. 

Some people have azacitidine. And some have a dummy drug (placebo Open a glossary item).

The main aims of the trial are to:

  • find out if azacitidine reduces the risk of AML or MDS coming back after a stem cell transplant 
  • learn more about the side effects

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

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

  • have AML or high risk MDS
  • are having a stem cell transplant with someone else’s cells
  • can start treatment between 42 days and 84 days after your stem cell transplant
  • are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • have satisfactory blood test results  
  • are willing to use 2 forms of reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant 
  • are at least 16 years old 

As well as the above, the following must also apply. 

Before you have the stem cell transplant. 

  • You hadn’t had a stem cell transplant in the past.
  • If you have high risk MDS less than 10% of your bone marrow Open a glossary item was made up of immature cells called blasts.
  • If you have AML, you had less than 5% of blasts in your blood. 

After you have the stem cell transplant. 

  • If you have AML, you had about 5% blasts or less in your bone marrow.
  • If you have MDS, the transplant worked well and you had a blast count of 5% or less in the blood marrow.

Who can’t take part

You cannot join this trial if any of these apply. 

Cancer related
You:

  • are having chemotherapy or a targeted drug   Open a glossary itemafter your stem cell transplant
  • have had azacitidine, decitabine or a similar drug in the past
  • have had lenalidomide, thalidomide or pomalidomide in the last 28 days
  • had a type of stem cell transplant called a haploidentical or a cord blood transplant
  • have moderate to severe graft versus host disease (GVHD Open a glossary item) that is causing symptoms (you may be able to take part if you have GVHD that is controlled with low dose steroids Open a glossary item
  • are taking high doses of steroids
  • have had any other cancer apart from cancer treated 5 years ago with the aim to cure and there have been no signs of it since apart from basal cell skin cancer Open a glossary item, squamous cell skin cancer Open a glossary item, CIS Open a glossary item of the cervix, LCIS Open a glossary item, very early prostate cancer, chronic myelomonocytic leukaemia (CMML) or AML caused by MDS

Medical conditions
You:

  • have inflammatory bowel disease, for example Chron’s disease, ulcerative colitis or any other digestive problem or disorder that can affect how you absorb medication 
  • have problems with your heart, such as a heart attack in the last 6 months
  • have a condition where your blood doesn’t clot properly
  • have an active infection that isn’t getting better with treatment
  • have HIV 
  • have an active hepatitis B or hepatitis C infection
  • have any other medical condition or mental health problem that the trial team think would affect you taking part

Other 
You: 

  • are allergic or sensitive to azacitidine or mannitol
  • are pregnant or breastfeeding 

Trial design

This is a phase 3 trial. The researchers need 324 people from the UK to take part. 

It is a randomised trial. A computer puts you into treatment groups. Neither you nor your doctor will be able to decide which group you are in. This is called a double blind trial. 

You have 1 of the following:

  • azacitidine
  • a dummy drug (placebo Open a glossary item)


Azacitidine and the dummy drug are tablets. You start treatment between 42 days and 84 days after your stem cell transplant. You have treatment in cycles. Each 28 day period is a cycle of treatment.  Day 1 is the first day of each treatment cycle. 

You:

  • take 1 tablet every day on day 1 to 14
  • don’t take any tablets on day 15 to 28

You have treatment for up to a year. 

You fill in a patient diary to record the treatment you take each day.

Quality of life
The trial team ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study

Samples for research
You give some extra blood samples and a bone marrow sample Open a glossary item during treatment. You give the samples at specific times and the trial team give you more information about this. 

They plan to use the samples to see how well treatment is working.

Hospital visits

You see a doctor and have some tests before you can take part. These include:

  • physical examination
  • blood tests
  • a heart scan (echocardiogram Open a glossary item)

You might also need to have a bone marrow test

You have the above tests again during and after your treatment. Where possible you have the blood tests at the same time as your routine blood tests. 

When you finish treatment, you see the doctor for a check up:

  • 1 month later
  • 3 months for 2 years 

Side effects

The trial team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything. 

As azacitidine is a new treatment for people with AML or MDS after a stem cell transplant, there might be some side effects we don’t know about yet. 

The most common side effects of azacitidine are:

  • a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • an increased risk of infection including pneumonia 
  • feeling or being sick
  • diarrhoea or constipation
  • feeling tired, unwell or weak
  • fever
  • sore throat with swelling or nostril pain
  • loss of appetite and weight loss
  • low blood levels of potassium in the blood which may cause tiredness, muscle weakness or cramps, or an irregular heart beat
  • pain (including muscles, joints, back, chest or stomach)
  • dizziness
  • headache
  • difficulty sleeping
  • shortness of breath
  • skin rash and itchiness
  • bruising, including tiny red or purple spots under the skin or other tissue
  • nosebleeds
     

Location

Birmingham
Bristol
Cambridge
Cardiff
Glasgow
Leeds
London
Manchester
Newcastle upon Tyne
Nottingham
Plymouth

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

Birmingham University
IMPACT partnership 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16166

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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