Liposomal mitoxantrone, venetoclax and azacitidine in relapsed/refractory acute myeloid leukaemia and early induction failure: a single-centre real-world study.

Introduction: Patients with relapsed/refractory acute myeloid leukaemia have poor outcomes, particularly after failure of venetoclax-based therapy. Methods: We retrospectively analysed 16 adults with relapsed/refractory AML or early induction failure who received liposomal mitoxantrone, venetoclax and azacitidine (MVA) at a single centre between March 2024 and August 2025. The primary endpoint was composite complete remission (CRc), defined as complete remission or complete remission with incomplete haematological recovery. Results: Median age was 58.5 years. Eight patients had relapsed AML, five had refractory AML and three had early induction failure; nine had previously failed venetoclax-based therapy. CRc was achieved in 10/16 patients (62.5%; 95% CI, 35.4% -84.8%), and the overall response rate was 14/16 (87.5%; 95% CI, 61.7% -98.4%). Among patients with prior venetoclax failure, 7/9 achieved CRc (77.8%; 95% CI, 40.0% -97.2%). Four patients proceeded to allogeneic haematopoietic stem cell transplantation (allo-HSCT). Grade 3 -4 neutropenia and thrombocytopenia occurred in 16/16 and 14/16 patients, respectively. No treatment-related deaths occurred during MVA therapy. Discussion: These findings suggest that MVA had clinical activity as a salvage regimen for difficult-to-treat AML, including patients with prior venetoclax failure, with expected myelosuppression and potential bridging utility before allo-HSCT. Prospective studies are needed to confirm efficacy and define patient selection.