A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome
The purpose of this study is to evaluate the effectiveness and safety of decitabine (Dacogen) intravenous injection in patients with Myelodysplastic Syndrome.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Prospective Multicenter Observational Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome|
- Number of patients with complete remission [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]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.
- Number of patients with partial remission [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]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)
- Number of patients with hematological improvement [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: After 4 cycles and end of treatment ] [ Designated as safety issue: No ]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.
- Cytogenetic response rate [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]
- Overall survival rate [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]Overall survival will be evaluated from the registration day to death.
- Time to acute myeloid leukemia evolution [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]The time of progression from myelodysplastic syndromes to acute myeloid leukemia.
- Number of patients with progression-free survival status [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]Hospitalization or undergoes surgical procedure due to disease progression.
- Number of patients with adverse event [ Time Frame: Up to 61 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Drug: No intervention
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041846
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|