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This investigational therapeutic regimen combines donor lymphocyte infusion (DLI) with the hypomethylating agent azacitidine. Developed by the Washington University School of Medicine, it is being evaluated for patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) following an allogeneic stem cell transplant. The approach aims to utilize the graft-versus-leukemia (GVL) effect of donor immune cells while using azacitidine to modulate T-cell function—specifically by increasing regulatory T cells—to reduce the risk of graft-versus-host disease (GVHD). Preclinical findings suggest that azacitidine administered shortly after DLI can alter T-cell function to prevent GVHD while maintaining the anti-tumor effects of the transplant.
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