The purpose of this study is to evaluate the safety and efficacy of DAC combined with HAAG regimen in the induction treatment of newly diagnosed AML patients older than 60 years.
This is a phase 3, open Label, single arm, multi-center study in elderly newly diagnosed AML patients. The patients will receive DAC combined with HAAG in the induction treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Decitabine:20mg/m2/d, d1\~5, intravenous infusion; Homoharringtonine:1mg/d,d3\~9,intravenous infusion; Aclarubicin:10mg/d, d3\~d6, intravenous infusion; Cytarabine:10mg/m2,q12h,d3-9, subcutaneous injection; Granulocyte colony-stimulating factor: 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection;
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall Response Rate (ORR)
ORR includes complete response (CR), CRi and PR. CR was defined as \< 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia; PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.
Time frame: Day 28-35 of induction course
Overall survival (OS)
time from randomization to death from any cause
Time frame: 3 years
Leukemia-free survival (LFS)
time from randomization to the first relapse or death
Time frame: 3 years
Cumulative incidence of relapse (CIR)
time from achievement of a remission to the first relapse
Time frame: 3 years
Number of adverse events
adverse events are evaluated with CTCAE V5.0.
Time frame: 2 years
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