A trial looking at decitabine for myelodysplastic syndrome and acute myeloid leukaemia (DEC-MDS)

This trial is for people with myelodysplastic syndrome (MDS) and also for people with acute myeloid leukaemia (AML) who have between 2 and 3 out of 10 blood cells (20 to 30%) that are immature.

Myelodysplastic syndrome (MDS) is a condition affecting the bone marrow. If you have MDS, your bone marrow makes abnormal blood cells, but not enough healthy blood cells. MDS can sometimes develop into acute myeloid leukaemia (AML). If you have a lot of abnormal cells in your bone marrow, there is a higher risk of the MDS becoming AML. Doctors may call this high risk MDS.

Doctors often treat high risk MDS with blood transfusions and antibiotics. This helps control the symptoms and fight infections that people with MDS might get. Doctors may call this ‘Best Supportive Care’ because it only improves the quality of life of people with MDS but does not treat their disease.

The researchers hope that a new drug called decitabine may be able to help treat people with high risk MDS and AML.

The aims of this trial are to find out

How well decitabine works for people with MDS and AML
The side effects of giving decitabine to people with MDS and AML

Recruitment

Start 22/09/2010

End 01/03/2013

Phase

Phase 2

Who can enter

You can enter this trial if you have

Myelodysplastic syndrome (MDS) with 1 in 20 (5%) or more of your blood cells being immature (blasts) and an average to high risk of the MDS becoming leukaemia – your doctor can advise you about this
Acute myeloid leukaemia (AML) with between 2 and 3 out of 10 of your blood cells (20 to 30%) being immature – your doctor will be able to explain this
A rare condition called chronic myelomonocytic leukaemia type 2 (CMML-2)

And also you

Have had azacitidine and your disease continued to grow, or come back, during treatment or come back in the 3 months after treatment or you stopped treatment due to bad side effects
Have satisfactory blood test results
Are well enough to be up and about for at least half the day (performance status 0, 1, 2)
Are willing to use reliable contraception while having treatment, and for 2 months after, if there is a chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have had decitabine before
Have had intensive combination chemotherapy to treat your MDS or AML before
Have had high dose cytarabine chemotherapy to treat your MDS or AML before
Have had a drug as part of another clinical trial in the last 30 days
Are taking steroid tablets (you should not stop taking your steroids without talking to your doctor)
Have another cancer
Have an infection
Are HIV positive
Have another medical condition that could affect you taking part in the trial
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit about 50 people. Everyone will have decitabine chemotherapy.

You have decitabine through a drip into a vein over 60 minutes. You have 5 days of decitabine every 28 days. Each 28 day period is called a cycle of treatment.

You continue to have decitabine as long as the side effects are not too bad and it is still helping you.