Can Exercise-Powered immune cells stop leukemia from coming back?
NCT ID NCT07254793
First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times
Summary
This early-phase trial tests a new approach using donor immune cells that have been mobilized through exercise to prevent or treat leukemia relapse after a stem cell transplant. The study will enroll 94 people with various blood cancers. Some will receive the exercise-mobilized cells to prevent relapse, while others will get them to treat minimal residual disease or active relapse. The goal is to see if these cells are safe and more effective than standard donor lymphocyte infusions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- exercise-mobilized NK-enriched donor lymphocyte infusions (DLI-X)
- What this could lead to
- If successful, this approach could offer a safer and more effective way to prevent or treat leukemia relapse after stem cell transplant, potentially improving survival and quality of life.
- What could go wrong
- This is a very early first-in-human trial with a small number of participants. The treatment may not work as hoped, and there are risks of graft-versus-host disease or other serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 94 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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) * 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. DLI Donor Inclusion Criteria: * 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. DLI Recipient Exclusion Criteria: * 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. DLI Donor Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
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- New drug takes aim at Treatment-Resistant leukemia
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