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Sponsored by: |
Xcyte Therapies |
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Information provided by: | Xcyte Therapies |
ClinicalTrials.gov Identifier: | NCT00058656 |
Patients will have immune cells collected and then expanded outside of the body. Patients will receive an infusion of a large number of expanded immune cells. There will be three dose levels studied. The goal of the study will be to determine the safety as well as potential efficacy of this treatment.
Condition | Intervention | Phase |
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Chronic Lymphocytic Leukemia |
Procedure: Infusion of Activated & Expanded Autologous T Cells |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Xcellerated T Cells(tm) in Patients With Chronic Lymphocytic Leukemia (CLL) |
Estimated Enrollment: | 18 |
Study Start Date: | March 2003 |
This is a Phase I/II single arm dose escalation study of a novel T cell immunotherapy for chronic lymphocytic leukemia (CLL). Patients will receive one dose of Xcellerated T Cells(tm), an ex vivo activated and expanded autologous T cell product, in an attempt to enhance immune responses with anti-tumor activity. This study is being conducted to test the safety and determine the maximum tolerated dose (MTD) of Xcellerated T Cells in patients with CLL. In addition, lymphocyte counts, lymph node area, and quantitative immunoglobulins will be assessed for preliminary evidence of a therapeutic effect. In correlative studies, changes in the phenotype of T and B lymphocytes will be evaluated by flow cytometry. Changes in T cell repertoire and anti-tumor immune activity will also be assessed. It is expected that 12 to 18 patients will be treated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
> 5 x 109 peripheral blood lymphocytes/L which are positive for CD5 and one or more B cell markers (CD19, CD20, CD23).
< 55% of lymphocytes identified as prolymphocytes
Patients with Intermediate Risk (Rai Stages I and II) must have active disease, as determined by one or more of the following criteria:
Exclusion Criteria
United States, California | |
University of California, San Diego | |
San Diego, California, United States, 92093-0663 | |
United States, Georgia | |
Atlanta Cancer Care | |
Roswell, Georgia, United States, 30076 | |
United States, Maryland | |
Center for Cancer & Blood Disorders | |
Bethesda, Maryland, United States, 20817 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Director: | Mark Frohlich, MD | Xcyte Therapies |
Study ID Numbers: | XT004 |
Study First Received: | April 8, 2003 |
Last Updated: | November 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00058656 |
Health Authority: | United States: Food and Drug Administration |
Immunotherapy T Cell Therapy Adoptive immunotherapy Xcellerate Xcellerated |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |