Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT

The primary objective of this proposal is to conduct the first-in-human randomized clinical trial evaluating prophylactic DLI-X (pro-DLI-X) for relapse prevention following matched sibling donor (MSD) or haploidentical (haplo) hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. Additionally, the study aims to assess the safety and efficacy of therapeutic DLI-X (t-DLI-X) compared to t-DLI alone in patients with minimal residual disease (MRD+) or overt relapse post-alloHCT. For patients with CD19-positive lymphoid malignancies, the study will incorporate blinatumomab, while those with myeloid or CD19-negative lymphoid malignancies will receive t-DLI-X or t-DLI alone. We hypothesize that both pro-DLI-X and t-DLI-X, with or without blinatumomab, will demonstrate safety and superior efficacy by enhancing graft-versus-leukemia (GvL) effects mediated by natural killer (NK) cells, γδ T cells, and CD8+ T cells, while maintaining manageable and treatment-responsive graft-versus-host disease (GvHD).

NCT Number	NCT07254793
Lead Sponsor	University of Arizona
Conditions	Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Acute Undifferentiated Leukemia (AUL), Myelodysplastic Syndrome, Chronic Myeloid Leukemia, Non-Hodgkin Lymphoma
Enrollment	94 participants
Start Date	2026-10-31
Primary Completion	2030-06-01 (estimated)
Study Completion	2030-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-13