Xcellerated T CellsTM for Non-Hodgkin's Lymphoma (NHL) Patients
NCT ID: NCT00081783
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Xcellerated T Cells
Eligibility Criteria
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Inclusion Criteria
* Stage III or IV disease at any time in the past
* Relapsed or refractory disease following most recent treatment. Patients are considered to have refractory disease if their last treatment course did not result in a complete or partial response, or if time to disease progression was six months or less. Patients are considered to have relapsed disease if time to disease progression is more than six months. Patients who have achieved a partial or complete response following most recent therapy must have demonstrated progressive disease.
* Patients must have received at least one prior course of systemic therapy for NHL and no more than four prior courses of therapy. Repeat courses of the same therapeutic regimen separated in time by six or more months are considered separate treatment courses, with the exception of single-agent rituximab. Patients with more than four prior courses of therapy may be enrolled at the discretion of the Medical Monitor after discussion with the Investigator.
* Radiographically bi-dimensionally measurable disease. Imaging need not be performed within 15 days prior to registration. Prior scans are acceptable provided that there has been no intervening therapy for NHL. Scans will be obtained at baseline, following registration.
* Age of at least 18 years
* ECOG performance status of 0 to 2
* White blood count (WBC) ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1000/mm3
* CD3+ \> 1% of total peripheral white blood cell count by flow cytometry
* Platelet count \> 50,000/mm3
* Hemoglobin ³ 10.0 g/dL. Transfusion with red blood cells or use of erythropoietin is permissible.
* Serum total bilirubin and alanine aminotransferase (ALT) ≤ 2.0 times the upper limit of normal
* Serum creatinine ≤ 2.0 mg/dL
* Serum human anti-mouse antibody (HAMA) titer undetectable or within the normal range, and no history of symptomatic allergic reactions to mice or murine (mouse) proteins. Patients with elevated HAMA levels may be enrolled at the discretion of the Medical Monitor after discussion with the Investigator.
* Negative test results for current/active infection with HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B and hepatitis C within 30 days of registration. (Antibody, antigen and nucleic acid tests acceptable, depending on institutional standards)
* Women of childbearing potential must have a negative serum pregnancy test. Both men and women agree to use a medically accepted form of contraception from the time of initial screening through completion of the study.
* Able to comprehend and provide signed informed consent
Exclusion Criteria
* Any T cell lymphoma
* Evidence of primary cutaneous anaplastic large cell lymphoma, Richter's Syndrome, large granular lymphocytosis and Sézary-cell leukemia. Patients with a prior diagnosis of chronic lymphocytic leukemia, as evidenced by absolute peripheral lymphocyte count of greater than 5,000 per mm3 at any time in the past, are not eligible.
* Leukemic manifestations of non-Hodgkin's lymphoma. Small lymphocytic lymphoma patients with peripheral lymphocyte count greater than 5,000 per mm3
* Receipt of any chemotherapy, monoclonal antibody, investigational or other systemic therapy (except glucocorticoids as noted below) for the treatment of NHL within 2 months prior to registration
* Receipt of glucocorticoids (with the exception of inhaled glucocorticoids) within 1 month prior to registration
* Receipt of intravenous immunoglobulin (IVIG) within 1 month of registration
* Registration for, or plans to participate in, any other clinical trial of an investigational agent concurrently with this trial
* History of malignancy other than NHL within five years of registration, except adequately treated basal or squamous cell skin cancer or in situ carcinoma of the cervix. Other exceptions must be approved by the Xcyte Therapies' Medical Monitor prior to registration.
* Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of registration
* Active autoimmune disease requiring systemic treatment
* Major organ system dysfunction including (but not limited to): New York Heart Association Class III or IV, severe pulmonary, renal, hepatic, gastrointestinal, neurologic or psychiatric dysfunction which would impair patient's ability to participate in the trial
* Any other pertinent medical or psychological condition which leads the Investigator to believe the study would not be appropriate treatment or in the patient's best interest
18 Years
ALL
No
Sponsors
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Xcyte Therapies
INDUSTRY
Principal Investigators
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Mark W. Frohlich, MD
Role: STUDY_CHAIR
Xcyte Therapies
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Jaime Chang
Role: primary
Lynne Smith
Role: primary
Vineeta Prasad
Role: primary
Cathy Wood
Role: primary
Jenny Zhang
Role: primary
Juli Murphy, BS, CCRC
Role: primary
Kathy Andrews
Role: primary
Susan Newton, RN
Role: primary
Natalie Bongiorno, RN, BSN
Role: primary
Richard Boyajian
Role: primary
Kelly Bryan
Role: primary
John Martin
Role: primary
Mary Weiss
Role: primary
Aubyn Grant, CCRP
Role: primary
Kim Williams, RN
Role: primary
Ana Ayala
Role: primary
Toni Oien, CCRC
Role: primary
Aimee Perrault-Gray
Role: primary
Other Identifiers
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XT009
Identifier Type: -
Identifier Source: org_study_id