Clinical Trial: Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Pilot Study of Prophylactic Dose-Escalation Donor Lymphocyte Infusion After T Cell Depleted Allogeneic Stem Cell Transplant in High Risk Patients With Hematologic Malignancies
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: University of Chicago
Current Primary Outcome: Proportion of patients who are able to receive at least one DLI treatment [ Time Frame: Up to 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression free survival [ Time Frame: Time to relapse or death as a result of any cause, assessed at 2 years ]Computed using the Kaplan-Meier product-limit estimate and expressed as probabilities with a 95% confidence interval (CI).
- Overall survival [ Time Frame: At 2 years ]Computed using the Kaplan-Meier product-limit estimate and expressed as probabilities with a 95% CI.
- Rate of acute GVHD (aGVHD) [ Time Frame: Up to 2 years ]Estimated by cumulative incidence method.
- Rate of chronic GVHD (cGVHD) [ Time Frame: Up to 2 years ]Estimated by cumulative incidence method.
- Treatment-related mortality [ Time Frame: Up to 2 years ]Estimated by cumulative incidence method. Cumulative incidence of treatment-related mortality with relapse of the original disease as the competing risk will be calculated.
Original Secondary Outcome: Same as current
Information By: University of Chicago
Dates:
Date Received: April 22, 2013
Date Started: April 2013
Date Completion: December 2017
Last Updated: July 20, 2016
Last Verified: July 2016