An observational study in Myelodysplastic Syndromes, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-10-16.
Sponsored by Seoul National University Hospital · Observational
In Myelodysplastic syndrome, epigenetic treatments such as Azacitidine and Decitabine have been highlighted in phase 3 studies. However, as the 1st line treatment, it has not been evaluated the head to head comparison of two drugs. This study is a retrospective study to compare the efficacy of two drugs.
Among 300 MDS patient, 200 of them have been taking Azacitidine and 100 of them have been taking Decitabine. Medical chart of these patients will be reviewed to assess the efficacy and safety between two agents.
1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.
This study's enrollment of 300 is above the median of 114 across 116 observational studies indexed under Preleukemia.
Browse Preleukemia studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
MDS patients who are diagnosed at SNUH
Exclusion Criteria:
200 MDS patients taking Azacitidine will be assessed
100 MDS patients taking Decitabine will be assessed
Response rate
Compare Azacitidine and Decitabine's treatment response rate in MDS patients
Time frame: 6 months
Efficacy
To compare hematologic improvement between Azacitidine and decitabine
Time frame: 6 months
Survival rate
To compare survival rate between Azacitidine and decitabine
Time frame: 6 months
Number of participants with non-hematologic toxicities
To compare toxicity between Azacitidine and decitabine
Time frame: 6 months
infection rate
To compare infection rate between Azacitidine and decitabine
Time frame: 6 months
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital