NCT03733834

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2018

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

1.9 years

First QC Date

November 6, 2018

Last Update Submit

November 6, 2018

Conditions

Standard TherapyNon-standard Therapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    The time from AML diagnosis to patients death or last folloeing-up.

    2 years

Secondary Outcomes (3)

  • Relapse-free survival

    2 years

  • Relapse incidence

    2 years

  • Treatment-related mortality

    1 year

Study Arms (2)

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.

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Newly diagnosed AML exclusive of APL; Age from 60 years old to 75 years old.

You may not qualify if:

  • Any abnormality in a vital sign (e.g., organ function failure, serious infection ) Patients with any conditions not suitable for the trial (investigators' decision)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Study Officials

  • Qifa Liu

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qifa Liu

CONTACT

+86-20-61641615liuqifa628@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 7, 2018

Study Start

October 8, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2021

Last Updated

November 7, 2018

Record last verified: 2018-11

Locations

CN(1)