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| ID | Type | Description | Link |
|---|---|---|---|
| DACOGENMDS4013 | Other Identifier | Janssen Korea, Ltd., Korea | |
| Long-term treatment of Dacogen | Other Identifier | Janssen Korea, Ltd., Korea |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | decitabine injection decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| decitabine injection | Drug | decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | every 28 days up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| The change of transfusion requirements | every 4 weeks up to approximately 5 years | |
| Overall survival | every 3 months up to approximately 5 years | |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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Secondary or tertiary hospitals in South Korea
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ansan | South Korea | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31375393 | Derived | Jung KS, Kim YJ, Kim YK, Park SK, Kim HG, Kim SJ, Park J, Choi CW, Do YR, Kim I, Park S, Mun YC, Jeong SH, Kim MK, Yi HG, Chang MH, Kim SY, Lee JH, Jang JH. Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System. Clin Lymphoma Myeloma Leuk. 2019 Oct;19(10):656-664. doi: 10.1016/j.clml.2019.06.003. Epub 2019 Jun 27. |
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| every 4 weeks up to approximately 5 years |
| Anyang |
| South Korea |
| Busan | South Korea |
| Cheonan | South Korea |
| Chungcheongbuk-Do | South Korea |
| Daegu | South Korea |
| Daejeon | South Korea |
| Gyeonggi-do | South Korea |
| Hwasun Gun | South Korea |
| Incheon | South Korea |
| Jinju | South Korea |
| Jungnam | South Korea |
| Kwanju | South Korea |
| Pusan | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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