The goal of this observational study is to to evaluate the efficacy and safety of Venetoclax in combination with DA60(daunorubicin 60 mg/m2/d for 3 days, and cytarabine 100 mg/m2 every 12 h for 7 days) induction and HD-AraC(cytarabine 3 g/m2 every 12 h for 3 days) consolidation, in young patients with newly diagnosed acute myeloid leukemia (AML).
Study Type
OBSERVATIONAL
Enrollment
45
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Disease-free survival (DFS)
DFS is calculated from the date of remission (inclusive of CR and CRi) to the date of relapse, death from any cause, or last follow-up.
Time frame: Assess up to 24 months.
Complete remission (CR) rate
The rate of patient who get CR after induction therapy.
Time frame: On Day 21 (window Day 21 to Day 35), a bone marrow aspirate specimen will be collected for morphology and pathology.
Rate of minimal residual disease (MRD) negativity
Percentage of patients achieving CR with no evidence of MRD after induction therapy, 1 cycle of consolidation therapy, and 4 cycles of consolidation therapy. MRD negativity is defined as \< 0.1% of CD45 expressing cells with the target immunophenotype, or as cycling threshold (Ct) ≥ 40 in ≥ 2 of 3 replicates by qPCR.
Time frame: MRD will be tested after every cycle of therapy and during follow-up.
Overall survival (OS)
OS is defined as the duration from initiation of induction treatment to the date of death from any cause or last follow-up.
Time frame: Assess up to 24 months.
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