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Haplo-identical donor lymphocyte infusion (HLI) is an investigational adoptive cellular immunotherapy developed by Nantes University Hospital for patients with high-risk acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy or allogeneic hematopoietic stem cell transplantation. The treatment involves the infusion of CD3+ T-lymphocytes collected from a haplo-identical donor (typically a first-degree relative) following a pre-treatment regimen of azacitidine and venetoclax. The therapeutic rationale is based on the graft-versus-leukemia (GVL) effect, where the donor's immune cells recognize and destroy the recipient's leukemic cells. The Phase I ILDA trial is evaluating the safety and optimal dosing of these infusions to maximize anti-leukemic activity while monitoring for potential toxicities such as graft-versus-host disease (GVHD).
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