Prophylactic DLI-X to Prevent Leukemia Relapse After Transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 interventional trial evaluates a prophylactic DLI-X strategy, comparing exercise-mobilized pro-DLI-X with standard prophylactic DLI in patients after allogeneic hematopoietic stem cell transplantation. The aim is to determine safety and whether the approach enhances graft-versus-leukemia effects mediated by NK cells, γδ T cells, and CD8+ T cells while keeping graft-versus-host disease manageable. Eligible participants include adults and young adults (0-65) with acute leukemia, MDS, CML, or related conditions undergoing MSD or haploidentical HCT, with a related donor able to participate in exercise sessions. The study is led by the University of Arizona at the Arizona Cancer Center.

Why it matters

Who can join: the full rules

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.

Where it's running

• The University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting

Study contacts

• Principal investigator: Emmanuel Katsanis, MD — University of Arizona
• Study coordinator: Michele Chu-Pilli
• Email: chum@arizona.edu
• Phone: 520-626-1183

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.