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This is a Phase II single arm study of a novel T cell immunotherapy in patients with indolent non-Hodgkin's lymphoma (NHL). Eligible patients will have relapsed or refractory disease after receiving at least one and no more than four prior regimens. Patients will receive Xcellerated T CellsTM, an ex vivo activated and expanded autologous T cell product, in an attempt to enhance immune responses with anti-tumor activity. The primary endpoint of the study is to evaluate the efficacy of Xcellerated T Cells in patients with indolent NHL. Secondary endpoints are to evaluate the safety of the therapy in this patient population, and to evaluate changes in the number and phenotype of T- and B-lymphocytes, as well as changes in the T cell receptor repertoire, hemoglobin levels, platelet counts and quantitative immunoglobulin levels. In a subset of patients, fine-needle aspirates of malignant lymph nodes will be performed to assess changes in the lymphocyte composition and phenotype. Bone marrow aspirates will be similarly evaluated. Finally, anti-tumor immune responses will be evaluated in patients amenable to biopsy of enlarged lymph nodes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xcellerated T Cells | Drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicki M. Mizuno | Contact | 206-262-6251 | vmizuno@xcytetherapies.com |
| Name | Affiliation | Role |
|---|---|---|
| Mark W. Frohlich, MD | Xcyte Therapies | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Cancer Care | Recruiting | Greenbrae | California | 94904 | United States |
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| University of Southern California | Not yet recruiting | Los Angeles | California | 90033 | United States |
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| University of California, San Diego | Recruiting | San Diego | California | 92093 | United States |
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| Sharp Memorial Hospital | Recruiting | San Diego | California | 92123 | United States |
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| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| Rocky Mountain Cancer Centers | Recruiting | Denver | Colorado | 80218 | United States |
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| Atlanta Cancer Care | Recruiting | Roswell | Georgia | 30342 | United States |
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| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21231 | United States |
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| Center for Cancer & Blood Disorders | Recruiting | Bethesda | Maryland | 20817 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
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| Cancer Institute of New Jersey | Recruiting | New Brunswick | New Jersey | 08903 | United States |
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| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Oregon Health Sciences University | Recruiting | Portland | Oregon | 97239 | United States |
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| Cancer Centers of the Carolinas | Recruiting | Greenville | South Carolina | 29605 | United States |
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| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Swedish Cancer Institute | Recruiting | Seattle | Washington | 98104 | United States |
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| Virginia Mason | Recruiting | Seattle | Washington | 98111 | United States |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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