Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients

This study is looking for adults aged 18 and over who have been diagnosed with either Acute Myeloid Leukaemia (AML) or a certain type of high-risk Myelodysplastic Syndrome (MDS). It's specifically for those patients who, for various reasons (like other health conditions or personal choice), are unable to have or prefer not to have very strong chemotherapy treatments.

To be considered for this study, your blood counts, like your white blood cells, liver function, and kidney function, need to be within certain ranges, unless the changes are clearly due to your AML/MDS. You should also be generally well enough to go about your daily activities with a good quality of life, as decided by your doctor.

You would not be able to join if you have a different specific type of leukaemia, certain other serious conditions, or if you've had another cancer treatment recently, unless it was for a type of cancer that was successfully treated a while ago. You must also be willing and able to use reliable contraception during and for 5 months after the study treatment if you could become pregnant or father a child.

If you join this study, you will receive treatment with either decitabine alone (given for 10 days) or decitabine combined with midostaurin. The treatments are given in cycles. After a maximum of three 10-day cycles, if your condition is responding well, the decitabine part of your treatment will continue with shorter 5-day cycles. You will have regular hospital visits for your treatment and to monitor your health, blood tests, and check how you're feeling and how the treatment is affecting you. The total duration of your participation will depend on how your condition responds to the treatment.