Acute myeloid leukemia (AML) is a clinically and biologically heterogeneous disease characterized by the clonal expansion of undifferentiated myeloid precursors. Although induction chemotherapy with cytarabine and daunorubicin/Idarubicin, typically called "7+3", has not changed for several decades, the best dosage of anthracycline is still unknown. Several prospective trials have demonstrated that intense dosage of anthracycline improved complete remission (CR) and overall survival (OS). Idarubicin 12mg/m2 (IA12) has been shown to be equal to dose intense daunorubicin (90 mg/m2 ) for achieving CR. Dose-intense daunorubicin 90 mg/m2 (DA90) has been shown to improve CR compared to standard dose daunorubucin 45mg/m2 in newly diagnosed AML patients. In our previous study, CR rate of induction with daunorubicin 60 mg/m2/d (3 days) and cytarabine 200 mg/m2/d days 1-7 was about 67%. Benefit of intensification seems limited to the patients without adverse cytogenetics. Wheher ultra high dose idarubicin 14mg/m2 (IA14) could further improve CR rate, give patients with adverse cytogenetics a chance to do allo-stem cell transplantation? This phase 2, prospective, single-center study is designed to evaluate the efficacy and safety of induction with idarubicin 14mg/m2/d (3 days) and cytarabine 200 mg/m2/d days 1-7 in young newly diagnosed AML patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Idarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days
Xinxin Cao
Beijing, Beijing Municipality, China
RECRUITINGComplete remission (CR) rate
the rate of patient who get CR after induction therapy
Time frame: On Day 21 (window Day 21 to Day 30), a bone marrow aspirate specimen will be collected for pathology.
Event-free survival (EFS)
EFS is defined as the duration from initiation of IA induction treatment to the date of a first event
Time frame: Assessed up to 24 months. Event is defined as any of the following: 1)Refractory disease (or treatment failure) which is determined at the end of the Induction Phase; 2)Relapse after CR or CRi; 3)Death from any cause at any time during the study.
Overall survival (OS)
OS was defined as the duration from initiation of IA induction treatment to the date of death or last follow-up
Time frame: OS was defined as the duration from initiation of IA induction treatment to the date of death or last follow-up assessed up to 24 months.
rate of Minimal Residual Disease (MRD) negativity
Percentage of subjects achieving CR with no evidence of Minimal Residual Disease (MRD) following induction therapy.
Time frame: MRD will be tested after on Day 21 (window Day 21 to Day 30)
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