Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT07254793
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Exercise Mobilized Prophylactic DLI — BIOLOGICAL
    Pro-DLI-X will be given through the patient's central line at an initial dose of 100,000 CD3+ cells/kilogram (kg) of recipient weight for haploidentical hematopoietic cell transplantation (haploHCT) and 300,000 CD3+ cells/kg for matched sibling donor hematopoietic cell transplantation (MSD HCT). Participants will receive up to 3 doses of pro-DLI-X, and each dose will be increased as follows: dose 2 will be 300,000 CD3+ cells/kg for haploHCT and 1,000,000 CD3+ cells/kg for MSD HCT; dose 3 will be 1,000,000 CD3+ cells/kg for haploHCT and 3,000,000 CD3+ cells/kg for MSD HCT.
  • Standard Prophylactic DLI — BIOLOGICAL
    Pro-DLI will be given through the patient's central line at an initial dose of 100,000 CD3+ cells/kilogram (kg) of recipient weight for haploidentical hematopoietic cell transplantation (haploHCT) and 300,000 CD3+ cells/kg for matched sibling donor hematopoietic cell transplantation (MSD HCT). Participants will receive up to 3 doses of pro-DLI-X, and each dose will be increased as follows: dose 2 will be 300,000 CD3+ cells/kg for haploHCT and 1,000,000 CD3+ cells/kg for MSD HCT; dose 3 will be 1,000,000 CD3+ cells/kg for haploHCT and 3,000,000 CD3+ cells/kg for MSD HCT.
  • Exercise Mobilized Therapeutic DLI — BIOLOGICAL
    t-DLI-X will be given through the patient's central line at an initial dose of 1,000,000 CD3+ cells/kilogram (kg) of recipient weight for haploidentical hematopoietic cell transplantation (haploHCT) and 3,000,000 CD3+ cells/kg for matched sibling donor hematopoietic cell transplantation (MSD HCT). Participants will receive up to 3 doses of t-DLI-X, and each dose will be increased as follows: dose 2 will be 3,000,000 CD3+ cells/kg for haploHCT and 10,000,000 CD3+ cells/kg for MSD HCT; dose 3 will be 10,000,000 CD3+ cells/kg for haploHCT and 30,000,000 CD3+ cells/kg for MSD HCT.
  • Standard Therapeutic DLI — BIOLOGICAL
    t-DLI will be given through the patient's central line at an initial dose of 1,000,000 CD3+ cells/kilogram (kg) of recipient weight for haploidentical hematopoietic cell transplantation (haploHCT) and 3,000,000 CD3+ cells/kg for matched sibling donor hematopoietic cell transplantation (MSD HCT). Participants will receive up to 3 doses of t-DLI-X, and each dose will be increased as follows: dose 2 will be 3,000,000 CD3+ cells/kg for haploHCT and 10,000,000 CD3+ cells/kg for MSD HCT; dose 3 will be 10,000,000 CD3+ cells/kg for haploHCT and 30,000,000 CD3+ cells/kg for MSD HCT.

Study Details

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 Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2030
Completion
Jun 1, 2030

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Prophylactic Arm
    Conduct the first-in-human, randomized clinical trial comparing prophylactic exercise mobilized donor lymphocyte infusion (pro-DLI-X) with standard (non exercise mobilized) prophylactic DLI (pro-DLI) for relapse prevention following allogeneic hematopoietic cell transplantation (alloHCT) in patients with myeloid or lymphoid malignancies.
  • Experimental: Therapeutic Arm
    Compare therapeutic exercise mobilized donor lymphocyte infusion (t-DLI-X) with standard (non exercise mobilized) therapeutic DLI (t-DLI) in a randomized trial for patients with evidence of minimal residual disease (MRD+) or overt relapse post-alloHCT for myeloid or CD19-negative lymphoid malignancies.

Primary Outcome Measure

Prophylactic endpoint: Graft-versus-Host Disease-Free, Relapse-Free Survival (GRFS) [ Time Frame: Assess between 1 to 3 years post HCT ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Arizona Cancer CenterTucsonArizona85719
Michele Chu-Pilli
[email protected]
520-626-1183
UACC IIT
[email protected]
Emmanuel Katsanis, MD (PRINCIPAL_INVESTIGATOR)
Richard Simpson, PhD (SUB_INVESTIGATOR)

Find similar trials in Tucson, AZ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
The University of Arizona Cancer Center· Tucson, AZ

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