Clinical trial NCT03733834: SD vs. NSD Therapy in Elderly AML
Official title: Comparisiom of Standard (SD) Therapy and Non-standard (NSD) Therapy in Elderly Acute Myeloid Leukemia (AML)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Standard Therapy
Non-standard Therapy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, Sun Yat-Sen University
name: Guangzhou First People's Hospital
name: Shenzhen Hospital of Southern Medical University
name: Wuhan General Hospital of Guangzhou Military Command
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Peking University Shenzhen Hospital
name: First Affiliated Hospital of Shenzhen University
name: Zhongshan People's Hospital, Guangdong, China
name: First Affiliated Hospital of Guangxi Medical University
name: Xiangya Hospital of Zhongnan University
name: The Third Xiangya Hospital of Central South University
name: First Affiliated Hospital of Gannan Medical University
First posted: 2018-11-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Relapse-free survival
timeFrame: 2 years
measure: Relapse incidence
timeFrame: 2 years
measure: Treatment-related mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qifa Liu
role: PRINCIPAL_INVESTIGATOR
References: