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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: Clinical Trial Phase 1 study, sponsored by University of Arizona.
NCT07254793 is a Phase 1 study that has not yet begun recruiting, run by University of Arizona. The registered enrollment target is 94 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Graft-versus-Host Disease-Free, Relapse-Free Survival (GRFS) is defined as survival without evidence of disease relapse or grade III-IV acute graft-versus-host-disease (aGvHD) or chronic graft-versus-host-disease (cGvHD) requiring systemic therapy. In essence, GRFS serves as a meaningful measure encompassing not only survival but quality of life. GRFS will be compared in patients randomized to pro-DLI-X versus standard pro-DLI control group.
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 |
What is known before NCT07254793 opens enrollment
NCT07254793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% higher).
The record links to 0 conditions, and to 4 interventions - of which Exercise Mobilized Prophylactic DLI is the first listed.
NCT07254793 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07254793's enrollment target sits among peer trials
94 615th of 2000 higher than 1,377 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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