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NCT07254793 · ClinicalTrials.gov registry record · Phase 1
Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT
A Phase 1 study, sponsored by University of Arizona.
- Not yet
- Registry status
- Phase 1
- Development phase
- 94
- Enrollment target
NCT07254793 is a Phase 1 study that has not yet begun recruiting, run by University of Arizona. The registered enrollment target is 94 participants.
The verdict
NCT07254793, a Phase 1 study, has not yet begun recruiting, sponsored by University of Arizona.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 94 participants
- Enrollment target
Study Summary
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).
Interventions
- BIOLOGICAL Exercise Mobilized Prophylactic DLI
- BIOLOGICAL Standard Prophylactic DLI
- BIOLOGICAL Exercise Mobilized Therapeutic DLI
- BIOLOGICAL Standard Therapeutic DLI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2026-05-31 |
| Est. Completion | 2030-06-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07254793
The ClinicalTrials.gov registry entry for NCT07254793 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Exercise Mobilized Prophylactic DLI is the first listed.
NCT07254793 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07254793 about?
NCT07254793 is a clinical study titled "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 mal...
What is the current status of trial NCT07254793?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2026-05-31. Estimated completion is 2030-06-01.
What interventions are being tested in trial NCT07254793?
The interventions under investigation include: Exercise Mobilized Prophylactic DLI (BIOLOGICAL), Standard Prophylactic DLI (BIOLOGICAL), Exercise Mobilized Therapeutic DLI (BIOLOGICAL), Standard Therapeutic DLI (BIOLOGICAL).
Who is sponsoring clinical trial NCT07254793?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
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