Spots Global Cancer Trial Database for Xcellerated T CellsTM for Non-Hodgkin's Lymphoma (NHL) Patients
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Trial Identification
Brief Title: Xcellerated T CellsTM for Non-Hodgkin's Lymphoma (NHL) Patients
Official Title: A Phase II Study of Xcellerated T CellsTM in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (NHL)
Study ID: NCT00081783
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
California Cancer Care, Greenbrae, California, United States
University of Southern California, Los Angeles, California, United States
University of California, San Diego, San Diego, California, United States
Sharp Memorial Hospital, San Diego, California, United States
University of California, San Francisco, San Francisco, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Atlanta Cancer Care, Roswell, Georgia, United States
Johns Hopkins University, Baltimore, Maryland, United States
Center for Cancer & Blood Disorders, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Washington University, St. Louis, Missouri, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Ohio State University, Columbus, Ohio, United States
Oregon Health Sciences University, Portland, Oregon, United States
Cancer Centers of the Carolinas, Greenville, South Carolina, United States
MD Anderson Cancer Center, Houston, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Virginia Mason, Seattle, Washington, United States
Contact Details
Name: Mark W. Frohlich, MD
Affiliation: Xcyte Therapies
Role: STUDY_CHAIR
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