Acute Myeloid Leukemia
Conditions
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.
Interventions
DRUGCAG 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.
cytarabine 20mg bid for 10 days.
Sponsors
Jianxiang Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| complete remission rate | 4 months |
| relapse free survival | 3 years |
| treatment-related mortality | 2 months |
Countries
China
Contacts
Primary ContactJianxiang Wang, MD
Backup ContactChunlin Zhou, MD
Outcome results
None listed