Summary

Acute myeloid leukemia (AML) relapse can be cured by an allogeneic hematopoietic cell transplantation (allo-HCT). During allo-HCT, the immune system of a donor is transferred into the patient and can eliminate residual malignant cells (graft-versus-leukemia effect, GVL).  However, immune escape and relapse are the most common cause of death for allo-HCT recipients. The treatment options for relapse are limited, and a second allo-HCT donor is available only for few patients. Therefore, there is a high unmet clinical need to develop novel therapeutic strategies. Based on this situation we are currently conducting the prospective Investigator-initiated trial (IIT) NIFAR "Phase 1/2 Trial to determine the Response Rate of Nivolumab in Acute Myeloid Leukemia (AML) relapse after Allogeneic Hematopoietic Cell Transplantation (allo-HCT)". The study combines the hypomethylating agents (HMA) decitabine or azacitidine with anti-PD-1 immunotherapy. The rationale of the clinical trial is, that administration of the anti-PD-1 antibody nivolumab might enhance alloreactive T cell responses and the GVL effect. Within the scientific program, we would like to study genomic, transcriptomic and phenotypic changes in AML and T cells of the patients during immunotherapy. These changes will be correlated with the patient outcome and clinical parameters to identify predictive factors for response to immunotherapy in allo-HCT recipients