Clinical Trials Directory

Trials / Completed

CompletedNCT01839916

Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Pilot Study of Prophylactic Dose-Escalation Donor Lymphocyte Infusion After T Cell Depleted Allogeneic Stem Cell Transplant in High Risk Patients With Hematologic Malignancies

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
77 (actual)
Sponsor
University of Chicago · Academic / Other
Sex
All
Age
14 Years – 75 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALtherapeutic allogeneic lymphocytesGiven IV
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2013-04-04
Primary completion
2018-08-01
Completion
2018-08-01
First posted
2013-04-25
Last updated
2019-08-07
Results posted
2019-08-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01839916. Inclusion in this directory is not an endorsement.