A Prospective Multicenter Observational Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome
The current trial is a prospective, multi-center, Phase 4, observational study that will
collect domestic data on the efficacy and safety of a five-day decitabine (Dacogen) regimen
in domestic patients with Myelodysplastic Syndrome (MDS). The results will be utilized as
basic data to establish the domestic guidelines for decitabine treatment. This study is
designed to observe the response rate and safety of decitabine in patients with MDS who were
treated with decitabine. All adverse events reported from the time a signed and dated
informed consent form is obtained until the last visit will be evaluated. Observational
Study - No investigational drug administered. The patient will receive decitabine
intravenous injection 20mg/m2 once a day for 5 consecutive days for every 4 weeks.
Observational Model: Case-Only, Time Perspective: Prospective
Overall response rate 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
After 4 cycles and end of treatment
Janssen Korea, Ltd. Clinical Trial
Janssen Korea, Ltd.
Korea: Food and Drug Administration