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

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, secondary 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 6 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  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   after 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 ) that is causing symptoms (you may be able to take part if you have GVHD that is controlled with low dose steroids
• are taking high doses of steroids
• have had any other cancer in the past. This doesn’t include basal cell skin cancer , squamous cell skin cancer , CIS  of the cervix,  LCIS , very early prostate cancer,  previous MDS, chronic myelomonocytic leukaemia (CMML) or AML caused by MPN. Or you have had another cancer treated at least 5 years ago with the aim to cure and there have been no signs of it since.

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