An observational study in Myelodysplastic Syndromes, sponsored by Janssen Korea, Ltd., Korea. Completed at 16 sites in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-05-25.
Sponsored by Janssen Korea, Ltd., Korea (part of Johnson & Johnson) · Observational
The purpose of this study is to investigate the overall response rate (ORR) and safety when treating patients with myelodysplastic syndrome with decitabine. Decitabine is to be administered as long as there is evidence of clinical benefit.
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.
2,165 studies on the registry are indexed under Myelodysplastic Syndromes; 322 are open to participants now.
This study's enrollment of 156 is close to the median of 146 across 219 observational studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →Janssen Korea, Ltd., Korea is the lead sponsor of 79 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Secondary or tertiary hospitals in South Korea
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
decitabine injection decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks
Drug: decitabine injection
decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks
overall response rate
Time frame: every 28 days up to approximately 5 years
The change of transfusion requirements
Time frame: every 4 weeks up to approximately 5 years
Overall survival
Time frame: every 3 months up to approximately 5 years
Adverse events
Time frame: every 4 weeks up to approximately 5 years
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.