This study evaluates Idarubicin (IDA) in combination with the intermediate-dose cytarabine, compared with intermediate-dose cytarabine alone, as a consolidation treatment for elderly AML in first remission.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Idarubicin 10mg/m²/day, D1 (IV)
Cytarabine 1.5g/m² /12h, D1-D3 (IV)
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGRelapse free survival
RFS
Time frame: 2 years
Toxicities
Number and CTC grade of all adverse events related to study treatment analyzed in an descriptive way
Time frame: enitire study course until 2 years
Minimum Residual Disease
Immunophenotypic characterization of human bone marrow cells will be done to determine MRD
Time frame: 6, 9, 12,18 and 24 months
Overall survival
OS
Time frame: 2 years
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