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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00870090 |
Purpose
The goal of this clinical research study is to learn if giving T-cells (immune cells) that have been specially processed in the laboratory will help chronic lymphocytic leukemia (CLL) patients' immune system recover faster after chemotherapy. This may help lower the chance of infections. The safety of this treatment will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Chronic Lymphocytic Leukemia |
Other: T-Cell Infusion |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Trial of Immune Reconstitution With CD3/CD28 Bead Activated T-cells Following Chemo-immunotherapy in Patients With Chronic Lymphocytic Leukemia. |
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Autologous Costimulated T-Cell Infusion |
Other: T-Cell Infusion
Intravenous infusion of co-stimulated T-cells at a dose of approximately 1 x 10^10 taking 10-30 minutes post chemo-immunotherapy.
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Chitra M. Hosing, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00870090 History of Changes |
| Other Study ID Numbers: | 2008-0210 |
| Study First Received: | March 24, 2009 |
| Last Updated: | October 31, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
T cell therapy Chronic Lymphocytic Leukemia CLL Immune Reconstitution |
CD3/CD28 bead activated T-cells T-Cells Immune Cells Leukapheresis |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |