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NCT07254793
Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT
Phase 1 trial testing Exercise Mobilized Prophylactic DLI in Acute Lymphoid Leukemia in 94 participants. Not yet recruiting.
1 June 2030
Quick facts
| Lead sponsor | University of Arizona |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 94 |
| Start date | 31 May 2026 |
| Primary completion | 1 June 2030 |
| Estimated completion | 1 June 2030 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Exercise Mobilized Prophylactic DLI — full drug profile →
- Standard Prophylactic DLI — full drug profile →
- Exercise Mobilized Therapeutic DLI — full drug profile →
- Standard Therapeutic DLI — full drug profile →
Conditions studied
- Acute Lymphoid Leukemia — all drugs for Acute Lymphoid Leukemia →
- Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
- Acute Undifferentiated Leukemia (AUL) — all drugs for Acute Undifferentiated Leukemia (AUL) →
- Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →
Sponsor
University of Arizona
Who can join
Under 65, any sex, with Acute Lymphoid Leukemia or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07254793
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07254793 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Arizona
- Last refreshed: 7 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07254793.
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