This pilot phase II trial studies how well giving donor T cells after donor stem cell transplant works in treating patients with hematologic malignancies. In a donor stem cell transplant, the donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Given IV
Correlative studies
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Percentage of Patients Who Are Able to Receive at Least One DLI Treatment
Time frame: Up to 2 years
Progression Free Survival (PFS)
Time to relapse or death as a result of any cause was evaluated at 2 years and the progression free survival rate was reported.
Time frame: 2 years
Overall Survival (OS)
Computed using the Kaplan-Meier product-limit estimate and expressed as probabilities with a 95% CI.
Time frame: At 2 years
Rate of Acute GVHD (aGVHD) With Any Grade
Estimated by cumulative incidence method.
Time frame: At 1 year and 2 year
Rate of Chronic GVHD (cGVHD)
Estimated by cumulative incidence method.
Time frame: At 1 year and 2 year
Treatment-related Mortality
Estimated by cumulative incidence method. Cumulative incidence of treatment-related mortality with relapse of the original disease as the competing risk will be calculated.
Time frame: At 2 year
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