Pilot Study of Prophylactic Dose-Escalation Donor Lymphocyte Infusion After T Cell Depleted Allogeneic Stem Cell Transplant in High Risk Patients With Hematologic Malignancies
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
Interventional
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
No
Hongtao Liu
Principal Investigator
University of Chicago Comprehensive Cancer Center
United States: Institutional Review Board
12-1191
NCT01839916
April 2013
May 2016
Name | Location |
---|---|
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |