Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter，Open-label，Radonmized Study on the Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years Old

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Daunorubicin
* Drug: Cytarabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary AML（except APL patients）; ECOG PS:0-2 Exclusion Criteria: AML patient who has already received induction treatment, no matter what the outcome is; Treatment-related AML; Active cancer patients who's condition need to be treated; The one with serious infectious diseases（eg.uncontrolled tuberculosis or invasive pulmonary aspergillosis） Active heart disease.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: escalated daunorubicin<br>Daumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days. | Drug: Daunorubicin<br>* defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses<br>* Other names: daunomycin;Drug: Cytarabine<br>* 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.<br>* Other names: cytosine arabinoside;|
| Active Comparator: standard daunorubicin<br>Daunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days. | Drug: Daunorubicin<br>* defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses<br>* Other names: daunomycin;Drug: Cytarabine<br>* 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.<br>* Other names: cytosine arabinoside;|
| Experimental: medium dosage cytarabine<br>1g/m2 q12h for 3 days as consolidation therapy. | Drug: Cytarabine<br>* 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.<br>* Other names: cytosine arabinoside;|
| Active Comparator: standard dosage cytarabine<br>100mg/m2 cytarabine for 6 days combined with aclacinomycin 20mg per day for 6 days as consolidation therapy. | Drug: Cytarabine<br>* 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.<br>* Other names: cytosine arabinoside;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate |  | 2 months | 
| relapse free survival |  | 3 years | 
| complete remission rate in different risk group |  | 2 month | 
| treatment-related mortality |  | 2 months |