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The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.
Total subjects: 240, doseⅠgroup of 120 patients, doseⅡgroup of 120 patients. Subjects are stratified randomize. If necessary, participants accepted best supportive therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Ⅰ | Experimental | Decitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks. |
|
| Arm Ⅱ | Experimental | Decitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine Injection | Drug | Decitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks; Decitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The safety and efficacy of decitabine treatment of Myelodysplastic Syndrome. | The primary efficacy evaluation: ORR The secondary efficacy evaluation: CR,mCR,PR,HI, PFS in one year, Cytogenetic response, transfusion requirements, et al. | 2-4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Hui, MD | Contact | 0086-022-60362636 |
| Name | Affiliation | Role |
|---|---|---|
| Shao Zonghong, MD | Tianjin Medical University General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
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| 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 |
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|
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |