This is a multicenter, prospective, single-arm clinical study designed to evaluate the efficacy and safety of the VA-CIG regimen (venetoclax combined with azacitidine, idarubicin, low-dose cytarabine and granulocyte colony-stimulating factor \[G-CSF\]) as induction therapy for previously untreated patients with fit acute myeloid leukemia (AML) who are eligible for intensive chemotherapy. This study aims to evaluate the efficacy and safety of the VA-CIG regimen in the target patient population.
Diagnosis of acute myeloid leukemia (AML, excluding acute promyelocytic leukemia) confirmed by morphology, immunophenotyping and molecular genetics, in accordance with the WHO 2022 diagnostic criteria for AML;
Age 18-70 years, with no gender restriction;
No prior AML-related treatment has been received; exceptions are made for the use of hydroxyurea or similar agents during the diagnostic screening phase to control peripheral blood leukemic blasts;
Patients must be assessed as tolerable to intensive chemotherapy regimens; evaluation of tolerance to intensive chemotherapy shall be performed in accordance with the Ferrara 2013 criteria (Appendix A);
Subjects with a history of myeloproliferative neoplasms (MPNs), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, and acute myeloid leukemia (AML) with BCR-ABL1 translocation;
Patients with a prior history of venetoclax or azacitidine (Aza) treatment for other diseases;
Known hypersensitivity to any component of the investigational medicinal products;
Presence of uncontrolled severe infection or active bleeding;
Single group
Venetoclax, Azacitidine, Cytarabine, Idarubicin, G-CSF
Drug* Venetoclax: 100 mg on Day 1, 200 mg on Day 2, 400 mg on Day 3, and 400 mg on Days 4-14, orally, once daily; * Azacitidine: 75 mg/m²/d, subcutaneous injection, on Days 1-7; * Cytarabine: 100 mg/m²/d, intravenous infusion, on Days 1-5; * Idarubicin: 6 mg/m²/d, intravenous infusion, on Days 1-3; * Human granulocyte colony-stimulating factor (G-CSF): 200 μg/m²/d, subcutaneous injection, from Day 0 until the white blood cell count \> 10×10⁹/L. One cycle lasts for 28 days
Composite complete response rate (CR+CRi)
CR is defined as: following two cycles of induction therapy, a blast count of \< 5% in the bone marrow, absence of Auer rods, no evidence of extramedullary leukemia, and peripheral blood absolute neutrophil count (ANC) and platelet count of \> 1×10⁹/L and \> 100×10⁹/L, respectively. CRi is defined as: fulfilling all criteria for CR, except for a persistent absolute neutrophil count (ANC) \< 1×10⁹/L or a persistent platelet count \< 100×10⁹/L.
MRD remission rate
Defined as: the number of patients who achieved MRD-negative status after induction therapy / the total number of patients who underwent MRD testing at that time point × 100%; MRD-negative is defined as an MRD level \< 10-⁴ in bone marrow samples;
Adverse events
Number of subjects with each adverse event.
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