This single-center prospective cohort study aims to evaluate the efficacy and safety of Intensifying treatment with Venetoclax along with intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML) except acute promyelocytic leukemia (non-APL) and exhibiting lower early peripheral blast clearance rate (EPBCR) after standard Intensive Induction therapy (3+7 regimen).
Newly diagnosed AML, except for the APL subtype, according to the 2022 World Health Organization classification (WHO 2022 criteria)
Age ≥18 years and ≤70 years
Eligible for intensive chemotherapy
No prior chemotherapy for AML except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell [WBC] counts>25x10^9/L)
AML with BCR-ABL1 or myeloid blast crisis of CML
Participants who have received prior treatment for AML with chemotherapy, hypomethylating agents, or venetoclax
≧71 years old OR
ECOG PS of 2-3
Single group
Venetoclax
DrugVenetoclax in the EPBCRlow cohort will be added to the ongoing 3+7 regimen. In the first induction cycle: venetoclax needs to be ramped up: 100 mg on day 5, 200mg on day 6, and 400mg on days 7-14, orally once daily. In the second induction (if required), venetoclax 400mg will be administered orally once daily on days 5-14 without a dose ramp-up schedule. Venetoclax in the EPBCRlow cohort during consolidation therapy: 400mg on days 1-7, orally once daily, along with the consolidation chemotherapy.
Idarubincin
DrugIdarubicin (IDA): 10mg/m\^2/d (age \<60 years old) or 6mg/m\^2/d on days 1-3, intravenously (IV).
Cytarabine
DrugDuring induction therapy: 100mg/m2/d on days 1-7, IV. During consolidation therapy: intermediate-dose cytarabine for age \>55 years old: 1.0g/m\^2 q12h on days 1-3, high-dose cytarabine for age ≦55 years old: 2g/m2 q12h on days 1-3.
CRc rate after one cycle of induction therapy
The proportion of participants achieving CR/CRi by the initiation of next cycle of therapy (each cycle is 28 days).
CRc rate after two cycle of induction therapy
The cumulative proportion of participants achieving CR/CRi after two cycles of induction therapy and before starting the next cycle of therapy.
CRMRD-Rate
The cumulative proportion of participants achieving CR/CRi without measurable residual disease after two cycles of induction therapy and before starting the next cycle of therapy.
Event-free survival (EFS)
The time from enrollment to treatment failure is defined as failure to achieve CR, CRi, or PR after two cycles of induction therapy, death from any cause, or relapse after achieving CR/CRi, whichever occurs first. If no specified events occur at the date of the last disease assessment, participants will be censored.
Relapse free survival (RFS)
From the date of achieving CR/CRi until the date of documented relapse or death due to any cause or the last follow-up day. If no specified events occur at the date of the last disease assessment, participants will be censored.
Baseline genomics
Genomics at baseline will be assessed at diagnosis using the Next-generation DNA sequencing.
Baseline transcriptomics
Transcriptomics at baseline will be assessed at diagnosis using the Next-generation RNA sequencing.
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