The purpose of this study is to assess the response rate at 6 months in Myelodysplastic Syndrome (MDS) patients, Chronic Myelomonocytic Leukaemia (CMML-2) patients, and Acute Myeloid Leukaemia (AML) patients with up to 30% bone marrow blasts, treated with low-dose decitabine who have previously failed therapy with 5-azacitidine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Patients will receive decitabine as a 20mg/m2 one hour intravenous infusion once daily on days 1 to 5 of a 4 week cycle.
King's College Hospital NHS Foundation Trust
London, United Kingdom
RECRUITINGOverall response rate in the efficacy-evaluable (EE) population
Time frame: 6 months
Overall survival
Time frame: 18 months
Time to AML progression (for MDS and CMML-2 patients only) or death
Time frame: 18 months
Haematological improvement
Time frame: 18 months
Transfusion requirements
Time frame: 18 months
Cytogenetic response
Time frame: 18 months
Treatment related toxicity
Time frame: Up until one month after last IMP dose
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