Acute Lymphoid LeukemiaPhase 1NCT07254793
Prophylactic DLI-X for Leukemia Relapse After HCT
A Phase 1 study testing Exercise Mobilized Prophylactic DLI and Standard Prophylactic DLI in people with Acute Lymphoid Leukemia and Acute Myeloid Leukemia, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Acute Undifferentiated Leukemia (AUL)
- What is being tested?
- Exercise Mobilized Prophylactic DLI and Standard Prophylactic DLI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 1 Jun 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
UACC IIT contact
United States1 site
The University of Arizona Cancer Center
Tucson, Arizona, 85719
Michele Chu-Pilli, 520-626-1183, chum@arizona.edu
UACC IIT, UACC-IIT@uacc.arizona.edu
About this study
Official title: A Feasibility/Pilot First-in-human Study of Exercise-mobilized NK-enriched Donor Lymphocyte Infusions (DLI-X) to Prevent Leukemia Relapse After Allogeneic Hematopoietic Cell Transplantation
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, Non-Hodgkin Lymphoma
- Being tested
- Exercise Mobilized Prophylactic DLI, Standard Prophylactic DLI
- Keywords
- Exercise, Donor Lymphocyte Infusion, Allogeneic Hematopoietic Stem Cell Transplantation, Hematologic Malignancies, Matched Sibling Donor, Haploidentical, Hematopoietic Cell Transplantation, DLI-X
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Biphenotypic, Acute, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Lymphoma, Non-Hodgkin, Motor Activity, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Mobilized Prophylactic DLIBiological
Also called pro-DLI-X
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 DLIBiological
Also called pro-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.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic DLI-X Arm | Experimental | 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. Receives: Biological: Exercise Mobilized Prophylactic DLI |
| Prophylactic Standard DLI Arm | Active comparator | 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. Receives: Biological: Standard Prophylactic DLI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prophylactic endpoint: Graft-versus-Host Disease-Free, Relapse-Free Survival (GRFS)
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.
Measured: Assess between 1 to 3 years post HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start30 Nov 2026 (estimated)
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Katsanis, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254793
- Sponsor's protocol ID
- STUDY00006003
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility/Pilot First-in-human Study of Exercise-mobilized NK-enriched Donor Lymphocyte Infusions (DLI-X) to Prevent Leukemia Relapse After Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT07254793
- Acronym / sponsor ID
- STUDY00006003
- Conditions
- Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Acute Undifferentiated Leukemia (AUL), Myelodysplastic Syndrome, Chronic Myeloid Leukemia, Non-Hodgkin Lymphoma
- Keywords
- Exercise, Donor Lymphocyte Infusion, Allogeneic Hematopoietic Stem Cell Transplantation, Hematologic Malignancies, Matched Sibling Donor, Haploidentical, Hematopoietic Cell Transplantation, DLI-X
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic DLI-X Arm | Experimental | Biological: Exercise Mobilized Prophylactic DLIConduct 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. |
| Prophylactic Standard DLI Arm | Active comparator | Biological: Standard Prophylactic DLIConduct 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. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Mobilized Prophylactic DLIAlso: pro-DLI-XPro-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. | Biological | Prophylactic DLI-X Arm |
| Standard Prophylactic DLIAlso: pro-DLIPro-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. | Biological | Prophylactic Standard DLI Arm |
Primary outcome
Prophylactic endpoint: Graft-versus-Host Disease-Free, Relapse-Free Survival (GRFS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
UACC IIT contact
Emmanuel Katsanis, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise Mobilized Prophylactic DLI and Standard Prophylactic DLI in people with Acute Lymphoid Leukemia and Acute Myeloid Leukemia, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Chu-Pilli (520-626-1183, chum@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prophylactic endpoint: Graft-versus-Host Disease-Free, Relapse-Free Survival (GRFS) (time frame: Assess between 1 to 3 years post HCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.