Donor Dendritic Cells And Donor Lymphocytes in Patients With Relapsed Hematologic Malignancies After Allogeneic Transplant
NCT00476177 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2012-03-29
Summary
The purpose of this study is to test the safety of adding donor dendritic cells to donor lymphocyte infusions, and to determine the type and severity of any side effects associated with this addition. Previously patients with hematologic malignancies who relapsed after transplant have been given infusions of donor white blood cells (donor lymphocyte infusion, DLI) as a way to boost their immune function and fight disease. Although DLI has led to cancer regression in some patients, the overall response rate using DLI alone is low, and unfortunately, rarely lasting. Researchers have discovered a new subset of blood cells, called dendritic cells (DC), which are crucial partners to lymphocytes in generating an immune response. We believe that the infusion of DC together with DLI may improve the ability of the donor lymphocytes to recognize and kill cancer cells.
Conditions
- Hematologic Malignancy
Interventions
- BIOLOGICAL
-
Infusion of donor dendritic cells
Given in the outpatient setting
- BIOLOGICAL
-
Infusion of donor lymphocytes
Given in outpatient setting
Sponsors & Collaborators
-
Brigham and Women's Hospital
collaborator OTHER -
Beth Israel Deaconess Medical Center
collaborator OTHER -
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Edwin Alyea, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-07-31
- Primary Completion
- 2007-08-31
- Completion
- 2009-07-31
Countries
- United States
Study Locations
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