Pilot Study of Prophylactic Dose-Escalation Donor Lymphocyte Infusion After T Cell Depleted Allogeneic Stem Cell Transplant in High Risk Patients With Hematologic Malignancies
I. To determine the feasibility of escalating dose regimen (EDR) donor lymphocyte infusion
(DLI) as measured by the proportion of patients who receive at least one DLI.
I. To assess progression free survival (PFS) at 2 years after stem cell transplant (SCT) for
high-risk hematologic malignancies receiving T-cell depleted grafts followed by escalating
dose regimen (EDR) prophylactic DLI compared to historical controls not receiving DLI.
II. To assess the safety of EDR DLI for high-risk hematologic malignancies as measured by
cumulative incidence of severe grade III-IV acute graft-versus-host disease (GVHD).
III. To measure outcomes of grade II-IV acute GVHD, non-relapse mortality, overall survival
and chronic GVHD of EDR DLI.
IV. To assess the full donor chimerism rate in the CD3 compartment and immune reconstitution
after EDR DLI.
Patients receive DLI intravenously (IV). Treatment repeats every 4-8 weeks for 5 doses in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients who are able to receive at least one DLI treatment
Up to 2 years
University of Chicago Comprehensive Cancer Center
United States: Institutional Review Board
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|