Updated Results from a Phase Ⅱ Clinical Trial：Safety and Efficacy of Azacitidine and Chidamide Maintenance after Allogeneic Hematopoietic Stem Cell Transplantation for Patients with High-Risk Acute Myeloid Leukemia
Abstract
Background
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is considered a potentially curative treatment for acute myeloid leukemia (AML), but the high recurrence rate after allo-HSCT of high-risk AML is a significant challenge. Effective and tolerable maintenance therapy is necessary, but options are limited. Chidamide, a histone deacetylase inhibitor, has been reported to elicit anti-tumor immune responses in mouse models and has been used for maintenance therapy in other hematological tumors in clinical practice. However, its use as maintenance therapy post allo-HSCT for AML patients has not been reported. Therefore, we conducted a multicenter, single-arm, phase II prospective study to investigate the safety and efficacy of combining azacitidine (AZA) with chidamide as maintenance therapy following allo-HSCT for high-risk AML patients(NCT05270200).
Methods
Patients aged 18-60 years with high-risk AML, defined by the European LeukemiaNet (ELN) 2017 adverse risk group, refractory, relapsed or secondary AML were enrolled. Maintenance therapy began 30 days after transplantation, with AZA administered at 100mg/day (days 1-5) for 6 cycles and chidamide 5mg daily (days 1-28) for up to 2 years. The AZA dose was adjusted to 50mg/m2/day (days 1-3) from Dec 23,2022 due to thrombocytopenia. If platelet(PLT) counts were below 50×109/L or grade 3/4 non-hematological toxicity occured, maintenance was interrupted or delayed until PLT counts exceeded 75×109/L or…
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