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In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen with intermediate dose of cytarabine at at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/Q12h on day5-7. In the control arm, patients receive DA regimen with standard dose of cytarabine at a dose of 100mg/㎡/d on day 1-7. Patients receive consolidation therapy containing high-dose cytarabine after achieved complete remission. Stem-cell transplantation is permitted for patients with intermediate- or poor-risk disease. The efficacy of induction therapy containing intermediate dose of cytarabine is evaluated and adverse events associated with treatment are recorded.The primary end point is overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA Regimen | Active Comparator | Patients receive standard DA induction regimen including daunomycin and cytarabine. |
|
| Intermediate Dose of DA Regimen | Experimental | Patients receive DA induction regimen including daunomycin and intermediate dose of cytarabine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daunomycin and Cytarabine (DA Regimen) | Drug | Cytarabine at a dose of 100mg/㎡/d on day 1-7. Daunomycin at a dose of 60mg/㎡/d on day 1-3. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival Rate (OS) | OS is defined as the time from the date of randomization until the date of death from any cause. | Within 5 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission Rate | Within 2 months after randomization | |
| Event-Free Survival Rate | Within 5 years after randomization | |
| Relapse-Free Survival Rate (RFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianxiang Wang, Dr | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Tianjin | Tianjin Municipality | China |
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| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Daunomycin and Cytarabine (Intermediate Dose of DA Regimen) | Drug | Cytarabine at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/d on day 5-7. Daunomycin at a dose of 60mg/㎡/d on day 1-3. |
|
|
| Within 5 years after randomization |
| Cumulative incidence of relapse | Within 5 years after randomization |
| Early Mortality | within 45 days after randomization |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |