SD vs. NSD Therapy in Elderly AML

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03733834

Collaborator

Second Affiliated Hospital, Sun Yat-Sen University (Other), Guangzhou First People's Hospital (Other), Shenzhen Hospital of Southern Medical University (Other), Wuhan General Hospital of Guangzhou Military Command (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other), Peking University Shenzhen Hospital (Other), First Affiliated Hospital of Shenzhen University (Other), Zhongshan People's Hospital, Guangdong, China (Other), First Affiliated Hospital of Guangxi Medical University (Other), Xiangya Hospital of Zhongnan University (Other), The Third Xiangya Hospital of Central South University (Other), The First Affiliated Hospital of Gannan Medical University (Other)

1,000

Enrollment

Location

34.8

Anticipated Duration (Months)

28.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Standard Therapy Non-standard Therapy

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 8, 2018

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Overall survival [2 years]
The time from AML diagnosis to patients death or last folloeing-up.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China	510515

Investigators

Principal Investigator: Qifa Liu, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qifa Liu, professor, Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT03733834

Other Study ID Numbers:

Therapy in elderly AML-2018

First Posted:

Nov 7, 2018

Last Update Posted: