This is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy.
The study plans to enroll 27 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.
Patients diagnosed with AML according to the WHO (2022) or ICC criteria, or with MDS/AML as defined by ICC (with 10%-20% blasts in the bone marrow)
Age ≥ 14 years, male or female.
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
Acute promyelocytic leukemia with PML::RARA fusion gene.
Acute myeloid leukemia with RUNX1::RUNX1T1 fusion gene.
Acute myeloid leukemia with BCR::ABL1 fusion gene.
Previously treated patients (defined as having received prior induction chemotherapy for AML/MDS; prior use of cytoreductive agents like hydroxyurea is allowed).
Single group
Venetoclax
DrugBCL-2 inhibitor. Oral. Induction: 100 mg day 1, 200 mg day 2, then 400 mg days 3-14.
Azacitidine
DrugHypomethylating agent. 75 mg/m²/day IV/SC on days 1-7 of induction.
Liposomal Mitoxantrone
DrugLiposomal topoisomerase II inhibitor. 24 mg/m² IV on day 1 of each induction cycle.
Cytarabine
DrugAntimetabolite. Consolidation: 2 g/m² (age \<60) or 1 g/m² (age ≥60) q12h IV on days 1-3 for 3 cycles.
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Procedure/SurgeryRecommended for high-risk or MRD+ patients after response.
complete remission rate after induction
Event-free survival
Overall survival
Relapse-free survival
MRD negativity rate by flow cytometry after 1 induction cycle
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