DLI-X for Leukemia

Overseen By UACC IIT

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Arizona

Must not be taking: Immunosuppressants

Disqualifiers: Severe GvHD, Active infection, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with certain blood cancers who have received a stem cell transplant from a relative. It examines the effectiveness of exercise-enhanced donor cell infusions (DLI) in preventing cancer recurrence or treating residual cancer. The study compares these enhanced treatments to standard donor cell infusions. Suitable participants have leukemia or a similar blood disorder and have undergone a stem cell transplant from a matched sibling or relative. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that donor lymphocyte infusions (DLI) are generally well-tolerated and can help the body fight leukemia. In past studies, patients who received DLI had long-term survival rates between 40% and 80%, suggesting that this treatment might be safe and effective in preventing relapse.

This trial examines a specific treatment called exercise-mobilized DLI. Donors exercise during blood cell collection, which may enhance the body's ability to fight leukemia. The goal is to boost the effect where the donor's immune cells attack the cancer cells.

Since this trial is in its early stages, the full safety profile of exercise-mobilized DLI is still under investigation. Early trials primarily focus on safety, so researchers will closely monitor participants for any side effects. One known risk with DLI treatments is graft-versus-host disease (GvHD), where donor cells attack the recipient's body, but it is expected to be manageable with treatment.

Prospective participants should consult their healthcare provider to fully understand the potential risks and benefits before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they incorporate exercise mobilization into donor lymphocyte infusions (DLI) for leukemia, a novel approach not used in standard treatments. Most current DLIs do not involve any form of exercise mobilization, which is thought to potentially enhance the effectiveness of the lymphocytes. The trial explores both therapeutic and prophylactic infusions, aiming to see if this method can better target minimal residual disease or help prevent relapse after stem cell transplants. By comparing exercise mobilized DLIs to standard DLIs, researchers hope to find out if this innovative technique can improve outcomes for patients with myeloid or certain lymphoid malignancies.

What evidence suggests that this trial's treatments could be effective for leukemia?

This trial will compare exercise-mobilized donor lymphocyte infusions (DLI-X) with standard donor lymphocyte infusions in two separate arms. Studies have shown that exercise-mobilized DLI-X can enhance the immune system's ability to fight leukemia. Research indicates that exercise preparation for DLI-X treatment can boost the body's natural ability to attack cancer cells, showing promise for chronic myeloid leukemia (CML). For preventive DLI-X, studies suggest that exercise can increase the cancer-fighting power of lymphocytes (a type of white blood cell) by up to 2.5 times. This method has also been linked to higher rates of remaining leukemia-free in some cases. Overall, early evidence is promising, suggesting that exercise-mobilized DLI-X could be a valuable approach in preventing and treating leukemia relapse after stem cell transplants. ^{1 2 3 5 6}

Who Is on the Research Team?

Emmanuel Katsanis, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for individuals with various types of leukemia or hematologic malignancies who have undergone a transplant from either a matched sibling donor or haploidentical source. Participants should not be experiencing overt relapse and must meet specific health criteria to ensure they can safely receive the interventions.

Inclusion Criteria

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

Provision of signed and dated informed consent form

I can have blood drawn for tests.

Exclusion Criteria

Pregnant or lactating

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prophylactic Treatment

Participants receive prophylactic exercise mobilized donor lymphocyte infusion (pro-DLI-X) or standard prophylactic DLI for relapse prevention following alloHCT

Varies

Therapeutic Treatment

Participants with minimal residual disease or overt relapse receive therapeutic exercise mobilized donor lymphocyte infusion (t-DLI-X) or standard therapeutic DLI

Varies

Follow-up

Participants are monitored for safety and effectiveness, including Graft-versus-Host Disease-Free, Relapse-Free Survival (GRFS) and disease response

1-3 years

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Mobilized Prophylactic DLI
• Exercise Mobilized Therapeutic DLI
• Standard Prophylactic DLI
• Standard Therapeutic DLI

Trial Overview The study tests whether DLI-X (donor lymphocyte infusion with exercise mobilization) can prevent leukemia relapse after transplantation, comparing it to standard DLI. It also evaluates if adding blinatumomab improves outcomes in certain patients.

How Is the Trial Designed?

Group I: Therapeutic Arm Experimental Treatment 2 Interventions

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.

Group II: Prophylactic Arm Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07254793

Prophylactic and Therapeutic DLI-X for Leukemia Relapse ... Conduct the first-in-human, randomized clinical trial comparing prophylactic exercise mobilized donor lymphocyte infusion (pro-DLI-X) with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12198174/

Exercise-mobilized donor lymphocyte infusions enhanced ... For instance, our research revealed that lymphocytes obtained during a vigorous 30-minute exercise session exhibited a 1.3 to 2.5-fold increase in killing ...

3. haematologica.org haematologica.org/article/view/12036

Prophylactic and pre-emptive donor lymphocyte infusion in ... With respect to DLI intensity, the rates of treatment success at 1 and 2 years were 69% and 76% after standard-intensity DLI, and 72% and 84% ...

4. astctjournal.org astctjournal.org/article/S2666-6367(25)01532-5/fulltext

Prophylactic Versus Preemptive Donor Lymphocyte ... Notably, the Pro-DLI cohort demonstrated higher 2-year leukemia-free survival (LFS: 56.3% versus 40.5%, P = .045) and markedly reduced 2-year ...

5. mdpi.com mdpi.com/2072-6694/17/17/2826

Exercise Delays Human Leukemia Progression and ... In the GvL model, exercise significantly lowered tumor burden and extended tumor-free survival in both DLI and vehicle control groups by 44.5% and 37.5%, ...

6. ashpublications.org ashpublications.org/blood/article/141/1/22/485176/How-I-treat-high-risk-acute-myeloid-leukemia-using

How I treat high-risk acute myeloid leukemia using preemptive ... On the contrary, timing has been suggested as a crucial determinant for both DLI efficacy and safety with unacceptable toxicity when ...