Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT

Starting soon · Phase 1

Conditions studied: Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Acute Undifferentiated Leukemia (AUL), Myelodysplastic Syndrome, Chronic Myeloid Leukemia, Non-Hodgkin Lymphoma

In brief

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).

Key facts

Study ID
NCT07254793
Run by
University of Arizona
People needed
94
Starts
2026-10-31
Expected to finish
2030-06-01
Last updated by the study team
2026-07-13

Who can join

Age: any, up to 65. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.