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Trial of Immune Reconstitution With CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia
The purpose of this research study is to test whether giving T-cells (type of white blood cell that are also known as immune cells) that have been specially processed in the laboratory will help chronic lymphocytic leukemia (CLL) patients' immune system return to normal faster after chemotherapy. This research study will also look into the ability of the lab to process the T-cells for infusion and the side effects of giving T-cells to patients with chronic lymphocytic leukemia (CLL).
Details
| Lead sponsor | University of Pennsylvania |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2009-03 |
| Completion | 2018-12 |
Conditions
- Chronic Lymphocytic Leukemia
Interventions
- Infusion of CD3/CD28 stimulated T cells
Primary outcomes
- The occurrence of treatment-related adverse events or treatment related trial discontinuations, defined as NCI CTC ≥ grade 3 and clinical events that are possible, likely, or definitely related to study treatment at any time — Two years
- The ability to complete the outlined course of therapy — Two years
- The ability to harvest, expand, and reinfuse autologous T cells in this target population of patients — Two years
Countries
United States