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| ID | Type | Description | Link |
|---|---|---|---|
| SHDC12010202 | Other Grant/Funding Number | Shanghai Shenkang Center for hospital development |
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The purpose of this study is to compare the efficacy of CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming) to decitabine in the treatment of higher-risk myelodysplastic syndromes(MDS).
Patients with higher-risk myelodysplastic syndrome (MDS) have a survival rate of 0.4 to 1.2 years as well as a high risk of their disease progressing to acute myeloid leukemia (AML). The only treatment with a curative potential is allogeneic stem cell transplantation. However, in the majority of patients, this treatment is not applicable, mainly due to the age of the recipients and comorbid conditions. Low-dose chemotherapy CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming)has been used to treat higher-risk MDS in China and achieve high response rate. Hypomethylating agents 5-aza-2'-deoxycytidine (decitabine) is nucleoside analogs that covalently bind to the DNA methyltransferases, irreversibly inhibiting their function, leading to the progressive loss of methylation and reversal of gene silencing. The purpose of this study is to compare the efficacy and safety of CHG regimen to Decitabine in higher-risk MDS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHG regimen | Experimental | one course of CHG regimen (low-dose cytarabine, homoharringtonine and G-CSF priming) |
|
| Decitabine | Active Comparator | one course of Decitabine (5-aza-deoxycytidine,Dacogen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHG regimen | Drug | cytarabine (25mg/d, days1-14) and homoharringtonine (1mg/d, days1-14) by intravenous continuous infusion, G-CSF (300 μg/d) by subcutaneous injection from day 0 until neutrophil count recovery to 2.0× 109/L. |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission rate | four weeks after one course of CHG or two courses of Decitabine |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | two years | |
| overall remission rate | four weeks after one course of CHG or two courses of Decitabine | |
| disease free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Li, Doctor | Contact | 008621-64369181-58745 | lixiao3326@yahoo.com.cn | |
| Lingyun Wu, Doctor | Contact | 008621-64369181-58336 | wu_lingyun@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao Li, Doctor | Shanghai 6th People's Hospital | Study Chair |
| Lingyun Wu, Doctor | Shanghai 6th People's Hospital | Study Director |
| Chunkang Chang, Doctor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai 6th People's Hospital | Shanghai | Shanghai Municipality | 200233 | 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 |
|---|---|
| D004358 | Drug Therapy |
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
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|
| 5-aza-deoxycytidine | Drug | Decitabine (5-aza-deoxycytidine)for injection, 20mg/m2/day, IV (in the vein) on days 1-5 of each 28 day cycle, Number of Cycles: 2. |
|
|
| two years |
| hematology toxicities | within the first 4 weeks after CHG or Decitabine regimen |
| non-hematologic toxicities | within the first 4 weeks after CHG or Decitabine |
| Shanghai 6th People's Hospital |
| Principal Investigator |
| 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 |