RecruitingHematologic Malignancies

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

Eligible age

18–80 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

This study is being done to assess the safety and determine the maximum tolerable dose (MTD) of TCRαβ+/CD19+-depleted Donor Lymphocyte Infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in highrisk patients with hematologic malignancies.

Sponsor: University of Wisconsin, Madison

You may qualify if…

✓ 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

You may not qualify if…

✕ Poor organ function as follows (According to the pre-transplant workups results):
✕ 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%
✕ NOTE: Exceptions to the above organ function exclusion criteria are allowable only with assent of the PI since the risks and benefits must be addressed for patients with potentially incurable hematologic malignancies. Such exceptions will be clearly documented in the subject's research record and will not be considered a deviation.
✕ Patients with uncontrolled intercurrent illness

Where it's recruiting

Wisconsin

Madison

Source: ClinicalTrials.gov · NCT07285668 · last updated 2026-09-14