SD vs. NSD Therapy in Elderly AML

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

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Qifa Liu; Phone Number: +86-20-61641615; Email: liuqifa628@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Department of Hematology,Nanfang Hospital, Southern Medical University
      • Contact: Guopan Yu; Phone Number: +86-020-62787883; Email: yugpp@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Newly diagnosed AML exclusive of APL with age range from 60 years old to 75 ages old. Patients are expect to live longger than 3 months.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Guangzhou First People's Hospital; Second Affiliated Hospital, Sun Yat-Sen University; The Third Xiangya Hospital of Central South University; Third Affiliated Hospital, Sun Yat-Sen University; Peking University Shenzhen Hospital; Zhongshan People's Hospital, Guangdong, China; Wuhan General Hospital of Guangzhou Military Command; First Affiliated Hospital of Guangxi Medical University; Shenzhen Hospital of Southern Medical University; First Affiliated Hospital of Shenzhen University; Xiangya Hospital of Zhongnan University; The First Affiliated Hospital of Gannan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Therapy in elderly AML-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No