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SD vs. NSD Therapy in Elderly AML

N

Nanfang Hospital, Southern Medical University

Status

Unknown

Conditions

Standard Therapy
Non-standard Therapy

Study type

Observational

Funder types

Other

Identifiers

NCT03733834
Therapy in elderly AML-2018

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

60 to 75 years old

Volunteers

No Healthy Volunteers

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)

Trial design

1,000 participants in 2 patient groups

SD therapy
Description:
SD therapy is definited as the treatment regimen must follow NCCN guildline and chemotherapy intensity could not be reduced.
NSD therapy
Description:
Non-standard (NSD) therapy is definited as patients receiving reduced-intensity therapy or only supporting care.

Trial contacts and locations

1

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Central trial contact

Qifa Liu

Data sourced from clinicaltrials.gov

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