Recruiting
Phase 1

pro-DLI-X

Sponsor:

University of Arizona

Code:

NCT07254793

Conditions

Acute Lymphoid Leukemia

Acute Myeloid Leukemia

Acute Undifferentiated Leukemia (AUL)

Myelodysplastic Syndrome

Chronic Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 0 - 65

Healthy Volunteers: Not accepted

Interventions

Exercise Mobilized Prophylactic DLI

Standard Prophylactic DLI

Study Details

Brief 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.

We hypothesize that pro-DLI-X 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).

Conditions

Acute Lymphoid Leukemia

Acute Myeloid Leukemia

Acute Undifferentiated Leukemia (AUL)

Myelodysplastic Syndrome

Chronic Myeloid Leukemia

Study ID

NCT07254793

Start date

Oct 26, 2026

Status verified date

Oct, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 65

Healthy Volunteers: Not accepted

DLI Recipient Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 0-65 years
  • Diagnosis of acute leukemia (lymphoid, myeloid or undifferentiated) myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) or non-Hodgkin's lymphoma (NHL)
  • Undergoing myeloablative or reduced intensity matched sibling donor (MSD) HCT or haploidentical HCT
  • Have a locally available healthy matched or haploidentical (≥5/10 HLA antigen matched) related donor between 12 and 50 years of age, consented and able to perform the exercise sessions. (see donor inclusion criteria)

DLI Donor Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Must have already met transplant donor eligibility as a matched sibling donor, or HLA-haploidentical relative of the patient, including biological parents, siblings, or children, half-siblings, cousins or aunts and uncles
  • Weight is greater than 30 kg
  • Age 12 and 50 years
  • Ability to undergo phlebotomy
  • Be able complete the fitness evaluation to determine VO2max and peak cycling power. Following successful completion of the donor fitness evaluation, the patients willing to participate in the randomized trial will be enrolled
  • Donor's recipient has met eligibility requirements and agreed to participate

DLI Recipient Exclusion Criteria:

  • Acute grade II-IV aGvHD or moderate/severe chronic GvHD at time of scheduled DLI.
  • Requiring immunosuppression therapy for treatment of GvHD.
  • Co-morbidities: AST/ALT greater than 5 x ULN; Bilirubin greater than 2 x ULN; Creatinine greater than 2 x ULN for age or creatinine clearance/GFR <40 ml/min/1.73m2; Pulmonary function: DLCO less than 40% of normal or O2 Sat less than 92%; Cardiac: left ventricular ejection fraction less than 35%; active infection; HIV positive; Karnofsky score (adults) less than 60% or Lansky score less than 50% (pediatrics)
  • Uncontrolled or severe bacterial, fungal or viral infection.
  • Positive serum or urine pregnancy test for girls post menarche or women of childbearing age.
  • Severe psychiatric illness or mental deficiency making compliance to treatment unlikely and/or and/or would preclude informed consent according to IRB requirements for the study.
  • Any reason, at the investigator's discretion, that the participation of the patient in this protocol would not be in patient's best interest, or where the patient would be unable to adhere to the study requirements.

DLI Donor Exclusion Criteria:

  • Unable to perform graded exercise test
  • Cardiac or pulmonary disease/condition that would restrict exercise
  • Positive anti-donor HLA antibody
  • Pregnant or lactating
  • Active infection
  • Severe psychiatric illness or mental deficiency making compliance with donation unlikely and/or would preclude informed consent according to IRB requirements for the study.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prophylactic DLI-X 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.

Patients on this arm will receive pro-DLI-X.

active comparator: Prophylactic Standard DLI 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.

Patients on this arm will receive standard DLI-X.

Interventions

Exercise Mobilized Prophylactic DLI

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

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.

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 and Locations

Central contacts

Michele Chu-Pilli

520-626-1183chum@arizona.edu

UACC IIT

UACC-IIT@uacc.arizona.edu

Locations

The University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Michele Chu-Pilli

520-626-1183chum@arizona.edu

UACC IIT

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Emmanuel Katsanis, MD

More Information

Sponsor

University of Arizona

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • Exercise
  • Donor Lymphocyte Infusion
  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Hematologic Malignancies
  • Matched Sibling Donor
  • Haploidentical
  • Hematopoietic Cell Transplantation
  • DLI-X

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.