The purpose of this study is to evaluate the effectiveness and safety of decitabine (Dacogen) intravenous injection in patients with Myelodysplastic Syndrome.
This is a prospective (in which the patients are first identified and then followed forward as time passes), multi-center (study conducted at multiple sites), observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) to evaluate the effectiveness and safety information of a 5 day decitabine (Dacogen) regimen in patients with Myelodysplastic Syndrome. This study consist of 3 phases; pre-treatment phase, treatment phase and end of treatment (Day 28\~61 after last administration of Dacogen). The patients will receive decitabine intravenous injection 20 mg/m2 one hour once daily for 5 consecutive days for every 4 weeks. Safety evaluations including adverse events and clinical laboratory tests and will be evaluated with adverse events reported for the period ranging from informed consent and during the study to the end of treatment visit including 56 days (8 weeks) after the last administration of the clinical study treatment.
Study Type
OBSERVATIONAL
Enrollment
103
This is an observational study. Patients receiving 20 mg/m2 of decitabine injection intravenously (into a vein) once daily for 5 days every 4 weeks will be observed.
Number of patients with complete remission
The complete response includes the evaluations of Bone marrow aspiration and biopsy (less than or equal to 5 percents myeloblast), persistent dysplasia and peripheral blood.
Time frame: Up to 61 days
Number of patients with partial remission
The partial response includes all complete remission evaluating parameters with the exception of bone marrow blasts are decreased by more than or equal to 50 percents over pretreatment but still more than 5 percents and cellularity (the state of a tissue or other mass as regards the number of its constituent cells) and morphology (examination of structure)
Time frame: Up to 61 days
Number of patients with hematological improvement
Time frame: Up to 61 days
Response rate
Response rate is the combination of complete remission, partial remission and hematological improvement and performed according to the response criteria of 'International Working Group 2006' which is standardized criteria for assessing response are essential to ensure comparability among clinical trials for patients with MDS.
Time frame: After 4 cycles and end of treatment
Cytogenetic response rate
Time frame: Up to 61 days
Overall survival rate
Overall survival will be evaluated from the registration day to death.
Time frame: Up to 61 days
Time to acute myeloid leukemia evolution
The time of progression from myelodysplastic syndromes to acute myeloid leukemia.
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Time frame: Up to 61 days
Number of patients with progression-free survival status
Hospitalization or undergoes surgical procedure due to disease progression.
Time frame: Up to 61 days
Number of patients with adverse event
Time frame: Up to 61 days