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

ConditionHematologic Malignancies

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Allogeneic donor TCRαβ+/CD19+ cell-depleted peripheral blood mononuclear cells

Treatment groups

38 Participants

are divided into 4 treatment groups

Sponsors and collaborators

University of Wisconsin, Madison

Lead sponsor

Source ClinicalTrials.gov