SD vs. NSD Therapy in Elderly AML

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-08

Study Completion Date

2021-09-30

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.

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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.

Conditions

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Standard Therapy Non-standard Therapy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SD therapy

SD therapy is definited as the treatment regimen must follow NCCN guildline and chemotherapy intensity could not be reduced.

No interventions assigned to this group

NSD therapy

Non-standard (NSD) therapy is definited as patients receiving reduced-intensity therapy or only supporting care.

No interventions assigned to this group

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)

Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No