A Prospective Multicenter Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome
This study is a prospective (the study follows a group of individuals over time), open label
(all people involved know the identity of the intervention), multicenter, single arm (one
group of patients receiving the same treatment), observational study to observe the response
rate and safety of decitabine when treating patients with myelodysplastic syndrome with
decitabine. Decitabine is to be administered as long as there is evidence of clinical
benefit. It will be assessed if the treatment duration could be prolonged by appropriate
toxicity management such as an active antibiotic prophylaxis or dose and schedule
modification, and whether this leads to potentially increased clinical benefits such as
higher response rate, longer time to Acute Myeloid Leukemia, and prolonged overall survival.
For safety evaluation, adverse events and peripheral blood findings will be collected. The
patient will receive decitabine intravenous injection 20mg/m2 once a day for 5 consecutive
days every 4 weeks.
Observational Model: Case-Only, Time Perspective: Prospective
overall response rate
every 28 days up to approximately 5 years
Janssen Korea, Ltd. Clinical Trial
Janssen Korea, Ltd.
Korea: Food and Drug Administration