SD vs. NSD Therapy in Elderly AML

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03733834

Enrollment

1000

Registered

2018-11-07

Start date

2018-10-08

Completion date

2021-09-30

Last updated

2018-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-standard Therapy, Standard Therapy

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to 75 Years

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)

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactQifa Liu

liuqifa628@163.com+86-20-61641615

Outcome results