A Single-Arm, Open-Label Study of Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) as Induction Therapy in Newly-diagnosed Adult Patients With Acute Myeloid Leukemia (AML)
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.
• Meet the following laboratory requirements (tests must be performed within 7 days prior to treatment):
• i. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the corresponding age group.
⁃ ii. AST and ALT ≤ 2.5 times ULN for the corresponding age group. iii. Serum creatinine \< 1.5 times ULN for the corresponding age group. iv. Cardiac enzymes \< 2 times ULN for the corresponding age group. v. Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiography (ECHO).