A Multicenter，Open-label，Randomized Study on the Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- overall survival
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to 75 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CAG regimen
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.
Intervention: CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF) (Drug)
Low dose cytarabine
cytarabine 20mg bid for 10 days.
Intervention: low dose cytarabine (Drug)
Outcomes
Primary Outcomes
overall survival
Time Frame: 3 years
Secondary Outcomes
- complete remission rate(4 months)
- relapse free survival(3 years)
- treatment-related mortality(2 months)
Investigators
Jianxiang Wang
vice-president
Chinese Academy of Medical Sciences