NCT02432911

Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old

A Multicenter，Open-label，Randomized Study on the Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Jianxiang Wang · Unknown
• Sex: All
• Age: 65 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.

Detailed description

Low dose cytarabine remains to be the choice of standard for elderly AML patients who are unfit or unwilling to receive intensive treatment. CAG regimen, which is a combination of aclacinomycin，low dose cytarabine±G-CSF is used often in elderly AML patients in China. It is proved effective and safety in some pilot studies，while there is no prospective，randomized study yet.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)	Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy.
DRUG	low dose cytarabine	cytarabine 20mg bid for 10 days.

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-05-01
• Completion: 2021-05-01
• First posted: 2015-05-04
• Last updated: 2016-10-07

Locations

1 site across 1 country: China