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This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.
Low dose cytarabine remains to be the choice of standard for elderly AML patients who are unfit or unwilling to receive intensive treatment. CAG regimen, which is a combination of aclacinomycin,low dose cytarabine±G-CSF is used often in elderly AML patients in China. It is proved effective and safety in some pilot studies,while there is no prospective,randomized study yet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAG regimen | Experimental | Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy. |
|
| Low dose cytarabine | Active Comparator | cytarabine 20mg bid for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF) | Drug | Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission rate | 4 months | |
| relapse free survival | 3 years | |
| treatment-related mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianxiang Wang, MD | Contact | +862223909120 | wangjx@cams.ac.cn | |
| Chunlin Zhou, MD | Contact | +8613820429085 | zhouchunlin@cams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Treatment and Diagnosis Center of Leukemia | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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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 |
|---|---|
| C411062 | CAG protocol |
| C011157 | aclacinomycins |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| low dose cytarabine | Drug | cytarabine 20mg bid for 10 days. |
|
|
| 2 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |