SD vs. NSD Therapy in Elderly AML

Study Overview
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Brief Summary
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It is known that treatment outcome could be positively associated with treatment intensity. However, tolerance of chemotherapy decreases in the elder, some patients could not tolerate standard (SD) therapy and even died of side effect, and overall survival (OS) might not be prolonged. Whether all elder acute myeloid leukemia (AML) patients could benefit from SD therapy, or some should receive reduced-intensity therapy or even only supporting care remains controvertal. In this multi-center study, we are going to evaluate the benefit of SD and non-SD (NSD) therapy in elder AML patients.

Detailed Description
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It is known that treatment outcome could be positively associated with treatment intensity. However, tolerance of chemotherapy decreases in the elder, some patients could not tolerate standard (SD) therapy and even died of side effect, and overall survival (OS) might not be prolonged. Whether all elder acute myeloid leukemia (AML) patients could benefit from SD therapy, or some should receive reduced-intensity therapy or even only supporting care remains controvertal. SD therapy is definited as the treatment regimen must follow NCCN guildline and chemotherapy intensity could not be reduced. Non-SD (NSD) therapy is definited as patients receiving reduced-intensity therapy or only supporting care. In this multi-center study, we are going to evaluate the benefit of SD and NSD therapy in elder AML patients.

Official Title
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Comparisiom of Standard (SD) Therapy and Non-standard (NSD) Therapy in Elderly Acute Myeloid Leukemia (AML)

Conditions
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Standard Therapy, Non-standard Therapy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed AML exclusive of APL; Age from 60 years old to 75 years old. Exclusion Criteria: Any abnormality in a vital sign (e.g., organ function failure, serious infection ) Patients with any conditions not suitable for the trial (investigators' decision)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SD therapy<br>SD therapy is definited as the treatment regimen must follow NCCN guildline and chemotherapy intensity could not be reduced. | |
| NSD therapy<br>Non-standard (NSD) therapy is definited as patients receiving reduced-intensity therapy or only supporting care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The time from AML diagnosis to patients death or last folloeing-up. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival | The time from AML patients obtaining CR to patients relapse or last folloeing-up. | 2 years | 
| Relapse incidence | Relapsed patients account for all the diagnosed AML patients. | 2 years | 
| Treatment-related mortality | The incidence of patients dying of treatment related complication. | 1 year |