Innate Donor Effector Allogeneic Lymphocyte Infusion After Stem Cell Transplantation The IDEAL Trial

What this Trial Is About

Researchers are investigating whether adding an innate donor lymphocyte infusion (iDLI) enriched with natural killer (NK) cells and T-cell receptor (TCR)  cells early after allogeneic hematopoietic stem cell transplantation (HSCT) can improve outcomes for adults with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The study aims to reduce the rates of acute graft-versus-host disease (GVHD) and relapse while enhancing relapse-free survival by harnessing the anti-leukemic effects of these innate immune cells, which may cause less harmful complications than traditional donor  T cells. Participants receive a standard HSCT procedure with peripheral blood stem cell grafts from either HLA-matched sibling donors or unrelated donors. Those with sibling donors will receive the experimental iDLI containing purified NK and TCR  cells 14 days after transplantation, while those with unrelated donors will receive the standard HSCT without iDLI. The iDLI is prepared by depleting  T cells and B cells from donor leukapheresis products to enrich the graft for innate effector cells, which are then infused into the patient shortly after processing. During the study, participants will be monitored through blood samples taken at various time points after transplantation to analyze immune cell populations and their recovery. Researchers will collect clinical data on acute GVHD incidence and relapse up to 100 days and one year post-transplant to assess the primary outcomes. Additional assessments include measuring the infused iDLI dose, immune cell phenotypes, and neutrophil engraftment. Data will be analyzed to evaluate the impact of iDLI on transplant success and patient survival, with follow-up lasting at least one year.

Innate Donor Effector Allogeneic Lymphocyte Infusion After Stem Cell Transplantation: the IDEAL Trial