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Prophylactic TCRαβ+/CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant

This study is testing a treatment called TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells (αβT/B dep-DLI) given after an allogeneic stem cell transplant (allo-SCT). This treatment aims to help high-risk patients with blood cancers (hematologic malignancies). The main goals are to see how safe αβT/B dep-DLI is and to find the highest dose that can be given without causing too many side effects. The study plans to enroll 38 participants aged 18 to 80 years old who have high-risk blood cancers like refractory acute myeloid leukemia (AML) or acute lymphoid leukemia (ALL). This study is currently unclear on its status, meaning it may not be actively recruiting yet.

Study design
This is an interventional study with a planned enrollment of 38 participants. It will involve finding the maximum tolerated dose of the treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
All participants will be followed for 2 years after receiving the donor lymphocyte infusion (DLI).

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NCT07285668

Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies

Recruiting
NAAges 18–80InterventionalTreatment
University of Wisconsin, Madison
~38 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events (AEs) from DLI to day 28 post-DLI
Measured over up to day 28 post-DLI (approximately day 63 on study)
+1 more outcome measured

Conditions

Hematologic Malignancies

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Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Jacques Galipeau, MD, FRCP(C) · STUDY_DIRECTOR · UW School of Medicine and Public Health
  • Hongtao Liu, MD, PhD · PRINCIPAL_INVESTIGATOR · UW Carbone Cancer Center

Who to contact

Cancer Connect
[email protected]
800-622-8922
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with high-risk myeloid or lymphoid malignancies determined to be eligible to undergo allo-SCT including but not limited to the conditions listed below. These criteria apply at the disease diagnosis or any time prior to the cyto-reductive therapy given before the planned conditioning:
Refractory acute myelogenous (AML) or lymphoid leukemia (ALL)
Relapsed AML or ALL
AML in European LeukemiaNet (ELN) high risk per cytogenetic and mutation
Any patients with minimal residual disease (MRD+) disease by flow cytometry or with active disease (not in complete remission (CR)) prior to allo-SCT
Myelodysplastic syndromes (MDS) with 5% or more blasts at initial diagnosis, or anytime during their treatment prior to allo-SCT.
Myelodysplastic syndrome (MDS) high risk or very high risk per Revised International Prognostic Scoring System (IPSS-R) or Molecular International Prognostic Scoring System (IPSS-M)
Chronic myelogenous leukemia (CML) in chronic phase failed 3 or more treatments, in accelerated or blast phase
High risk primary myelofibrosis (PMF) per Dynamic International Prognostic Scoring System (DIPSS)-plus or Mutation-enhanced International Prognostic Scoring System for Transplant-age Patients (MIPSS70+)
PMF in accelerated or blast phase
Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a partial response at transplant
High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen
Other high risk hematologic malignancies for which allo-SCT is deemed clinically necessary per PI and based on institutional standards
The donor for the allo-SCT must be:
Related AND
Matched OR mismatched OR haploidentical at HLA-A, -B, -C, and -DRB1 by molecular methods
ECOG performance score of 0-2
Ability to understand and willingness to sign written informed consent document
Willing to comply with all study procedures and be available for the duration of the study
Individuals in sexual relationships that could result in pregnancy or impregnation of their partner must use an acceptable method of contraception§ from enrollment until 4 weeks after completing study treatment.

Exclusion

Creatinine ≥ 2.0 mg/dL
SGOT and SGPT ≥ 5 x ULN. Liver biopsy per clinician discretion.
Bilirubin ≥ 3 x ULN (unless Gilbert's syndrome)
DLCO \< 50% corrected for hemoglobin
Left ventricular ejection fraction or shortening fraction \< 40%
Patients with uncontrolled intercurrent illness
Patients with psychiatric illness/social situations that would limit compliance with study requirements

What this trial measures

  • Incidence of Adverse Events (AEs) from DLI to day 28 post-DLIup to day 28 post-DLI (approximately day 63 on study)

    To assess safety of prophylactic TCRαβ+/CD19+ depleted donor lymphocyte infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in high-risk patients with hematologic malignancies, incidence of AEs will be reported.

  • Maximum Tolerated Dose or Maximum Administered Doseup to day 28 post-DLI (approximately day 63 on study)

    MTD/MAD defined as the highest dose level at which less than 2 of 6 participants experience a DLT.