A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome
|ClinicalTrials.gov Identifier: NCT01041846|
Recruitment Status : Completed
First Posted : January 1, 2010
Last Update Posted : July 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome||Drug: No intervention||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||103 participants|
|Official Title:||A Prospective Multicenter Observational Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome|
|Study Start Date :||December 2008|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
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.
- Number of patients with complete remission [ Time Frame: Up to 61 days ]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 ]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 ]
- Response rate [ Time Frame: After 4 cycles and end of treatment ]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 ]
- Overall survival rate [ Time Frame: Up to 61 days ]Overall survival will be evaluated from the registration day to death.
- Time to acute myeloid leukemia evolution [ Time Frame: Up to 61 days ]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 ]Hospitalization or undergoes surgical procedure due to disease progression.
- Number of patients with adverse event [ Time Frame: Up to 61 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041846
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|