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

Not Applicable

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF); Drug: low dose cytarabine

• Registration Number: NCT02432911
• Lead Sponsor: Jianxiang Wang

Brief 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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-05-01
• Study First Posted: 2015-05-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07
• Primary Completion: 2018-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Acute myeloid leukemia except APL
• ECOG PS：0-3
• Unfit or unwilling to receive intensive therapy

Exclusion Criteria

• The one who has already received induction therapy no matter what the outcome is.
• Active cancer patients who are needed to receive treatment;
• Serious uncontrolled infectious diseases(eg.tuberculosis or invasive pulmonary aspergillosis）；
• Active heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAG regimen	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.
Low dose cytarabine	low dose cytarabine	cytarabine 20mg bid for 10 days.

Primary Outcome Measures

Name	Time	Method
overall survival	3 years

Secondary Outcome Measures

Name	Time	Method
treatment-related mortality	2 months
complete remission rate	4 months
relapse free survival	3 years

Trial Locations

Locations (1)

Treatment and Diagnosis Center of Leukemia; 🇨🇳 Tianjin, Tianjin, China