Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients.
Retrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival.
Since AML is a highly heterogeneous disease, it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy.
Therefore, this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients, and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups.
Patients who meet AML according to WHO (2022) or AML and MDS/AML defined by ICC standards.
Age ≥14 years old, ≤ 60 years old, male or female.
The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);
Acute promyelocytic leukemia with PML-RARA fusion gene
Acute myeloid leukemia with BCR-ABL fusion gene
Treated patients (but can receive hydroxyurea or cytarabine to the lower tumor burden).
Concurrent malignant tumors of other organs (those requiring treatment).
Single group
Daunorubicin
Drug60mg/m2/d d1-3 in Induction therapy
Cytarabine
DrugCytarabine 100mg/m2/d d1-7 in Induction therapy, 2g/m2 q12h d1-3 in Consolidation therapy
Venetoclax
Drug100mg d-2, 200mg d-1, 400mg d1-7 in Induction therapy, 400mg d1-7 in Consolidation therapy and Maintenance treatment
Azacitidine
Drug75mg/m2/d d1-5
Event-free survival (EFS)
All patients definitions for the trial; From the date of enrollment to the time of treatment failure after two courses of induction therapy, recurrence after CRc, date of all-cause death, or the date of last survival follow-up.
Complete remission (CR)/CR with partial hematologic recovery (CRh)/CR with incomplete hematologic recovery (CRi) with negative MRD detected by flow cytometry
The ratio of CR/CRh/CRi with negative MRD detected by flow cytometry after induction, consolidation, and maintenance therapy.
CR/CRh/CRi with negative MRD detected by PCR
The ratio of CR/CRh/CRi with negative MRD detected by PCR after induction, consolidation, and maintenance therapy.
overall survival (OS)
Used to evaluate all patients who enter clinical trials. From the date of entry into the trial until the date of patient death (including any cause) or last survival follow-up.
30-day mortality
Percentage of patients who died within 30 days from enrollment.
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