A phase II clinical trial evaluating the efficacy and tolerability of induction and consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin (modified-FLAI) in the elderly patients with acute myeloid leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
fludarabine, cytarabine, idarubicin
Seoul National University Hospital
Seoul, South Korea
Complete remission rate
Rate of complete remssion (CR) after two cycles of m-FLAI induction
Rate of serious adverse events (SAE)
Number of patients dying from SAE related to m-FLAI induction
Event Free Survival
Event free survival defined as a period from study enrollment to death by from cause or relapse of disease after complete remission
overall survival
Overall survival defined as a period from study enrollment to death from any cause
Predictive factors for Complete remission
Compare complete remission rate according to existence of specific chromosome abnormality and Charlson comorbidity index to evaluate predicative impact of these factors.
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