Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT

This study is looking at new ways to prevent and treat leukemia relapse after a hematopoietic cell transplant (HCT), also known as a bone marrow transplant. Researchers are testing two types of donor lymphocyte infusion (DLI): "Exercise Mobilized DLI" (Pro-DLI-X and t-DLI-X) and "Standard DLI" (Pro-DLI and t-DLI). These infusions use immune cells from a donor to help fight cancer. The study is for people aged 0-65 with certain blood cancers like acute leukemia, myelodysplastic syndrome, or chronic myeloid leukemia. Success will be measured by how long patients live without relapse and without severe graft-versus-host disease (GvHD), a common transplant complication. The current recruitment status is unclear.

Study design: This is a randomized clinical trial, meaning participants will be assigned to different treatment groups by chance. The study plans to enroll 94 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be assessed for outcomes between 1 to 3 years after their hematopoietic cell transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT

Not Yet Recruiting

PHASE1Up to 65InterventionalTreatment

University of Arizona

~94 participants

Updated 2026-07-13 on ClinicalTrials.gov

What's tested:Exercise Mobilized Prophylactic DLIStandard Prophylactic DLIExercise Mobilized Therapeutic DLIStandard Therapeutic DLI

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Prophylactic endpoint: Graft-versus-Host Disease-Free, Relapse-Free Survival (GRFS)

Measured over Assess between 1 to 3 years post HCT

+1 more outcome measured

Conditions

Acute Lymphoid Leukemia

Acute Myeloid Leukemia

Acute Undifferentiated Leukemia (AUL)

Myelodysplastic Syndrome

Chronic Myeloid Leukemia

Non-Hodgkin Lymphoma

Where it's being run

1 sites across 1 states

Arizona1

Study leadership

Emmanuel Katsanis, MD · PRINCIPAL_INVESTIGATOR · University of Arizona

Who to contact

Michele Chu-Pilli

[email protected]

520-626-1183

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

The familial donors will first complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.

Matched sibling donor or HLA-haploidentical relatives 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

Cardiac, renal, pulmonary, and hepatic function within normal limits

Complete blood count (CBC) with differential and platelet count within normal limits, and CMP within normal limits as deemed acceptable by the Principal Investigator and provider evaluating donor.

The familial donors should be able complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.

Exclusion

Acute grade III-IV aGvHD or moderate/severe chronic GvHD.

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 informed consent impossible.

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.

Unable to perform graded exercise test

Cardiac or pulmonary disease restricting exercise

Positive anti-donor HLA antibody

Pregnant or lactating

Active infection

Positivity for HIV, hepatitis B (HBV), hepatitis C (HCV), human T-cell lymphotropic virus (HTLV-I/II)

Severe psychiatric illness or mental deficiency making compliance with donation unlikely and/or informed consent impossible.

What this trial measures

Prophylactic endpoint: Graft-versus-Host Disease-Free, Relapse-Free Survival (GRFS)Assess between 1 to 3 years post HCT
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.
Therapeutic endpoint: Disease response to t-DLI versus t-DLI-X (relapse and GvHD rates as a composite endpoint)Assess between 1-3 years post HCT
A parallel two-group design will be used to test whether the percent response to t-DLI-X (treatment) is different from the percent response to t-DLI (control).

Trialytics