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The purpose of this study is to determine whether the escalation dosage of Daunorubicin and cytarabine is effective and safety in the treatment of older adult Chinese acute myeloid leukemia(AML) patients aged 55 to 65 years.
the DA 3+7 regimen is the standard therapy in the AML treatment.Escalated dosage of daunorubicin in induction therapy is reported effective and result in a more rapid response and a higher response rate than does the conventional dose, without additional toxic effects in elderly AML patients between 60 to 65 years.Higher Overall survival rate and Event-free survival rate was obtained in escalated group compared with conventional dose. We are wondering if Chinese older AML patients can benefit from this escalated induction regimen.
High dose cytarabine in AML consolidation is reported improving the survival of elderly AML patients than the conventional dose,but it is not determined in Chinese older adult AML patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| escalated daunorubicin | Experimental | Daumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days. |
|
| standard daunorubicin | Active Comparator | Daunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days. |
|
| medium dosage cytarabine | Experimental | 1g/m2 q12h for 3 days as consolidation therapy. |
|
| standard dosage cytarabine | Active Comparator | 100mg/m2 cytarabine for 6 days combined with aclacinomycin 20mg per day for 6 days as consolidation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daunorubicin | Drug | defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission rate | 2 months | |
| relapse free survival | 3 years | |
| complete remission rate in different risk group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunlin - Zhou, MD | Contact | +8613820429085 | zcl7317@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianxiang Wang, MD | ChineseAMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Treatment and Diagnosis Center of Leukemia | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41986965 | Derived | Zhou C, Li L, Li Y, Liu K, Liu Y, Lin D, Gong B, Zhang G, Gong X, Fang Q, Liu B, Qiu S, Wang Y, Wei H, Mi Y, Wang J. Daunorubicin-45 Vs. Daunorubicin-60 for Induction in Intermediate-Age Patients of AML: Results From a Randomized Trial. Cancer Sci. 2026 Jun;117(6):1690-1700. doi: 10.1111/cas.70383. Epub 2026 Apr 15. |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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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|
| Cytarabine | Drug | medium dosage cytarabine(1 g/m2 q12h for 3 days) compared with standard dosage cytarabine(100mg/m2 per day for 6 days)combinated with aclacinomycin(20mg per day for 6 days)for consolidation therapy. |
|
|
| 2 month |
| treatment-related mortality | 2 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| 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 |