Clinical Trials. gov identifier:
NCT01251627
Study code:
AISSM06-DECI2009
N° of patients expected by the study:
41
Study status:
End of the enrollment
Age:
> 18 years old
Myelodysplasia object of the study:
CMML ( Chronic MyeloMonocytic Leucemia)
Multicentric phase II study
Title of the study:
PHASE II MULTICENTER OPEN LABEL STUDY TO EVALUATE THE EFFICACY OF DECITABINE IN THE TREATMENT OF CHRONIC MYELOMONOCYTIC LEUKEMIA
Description of the study:
CMML is a rare chronic disease, between myelodysplastic and myeloproliferative syndromes. The main treatment for this disease is Hydroxyurea, but in recent years the use of Decitabine as a hypomethylating agent has also been studied.
The primary objective of the trial is to assess the activity of decitabine in the treatment of CMML.
This is a multicentric phase II interventional trial; the Sponsor was AISSM (Italian Association for the Study of Myelodysplastic Syndromes), then evolved in FISM.
The last patient was enrolled in October 2011.
Currently there is still a patient in therapy.