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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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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Subjects who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968
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Detailed Description
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Conditions
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Interventions
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Axicabtagene Ciloleucel
Axicabtagene Ciloleucel and A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. DLBCL, not otherwise specified
2. Primary mediastinal large B-cell lymphoma
3. High-grade B-cell lymphoma
4. DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL)
2. Relapsed or refractory disease, defined as one or more of the following:
1. No response to first-line therapy (primary refractory disease); subjects who are intolerant to first-line therapy chemotherapy are excluded OR
2. No response or relapse to second or greater lines of therapy OR
3. Relapsed after ASCT
3. Subjects must have received adequate prior therapy including at a minimum:
1. anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and
2. an anthracycline containing chemotherapy regimen;
4. No evidence, suspicion, and/or history of central nervous system (CNS) involvement of lymphoma
5. Age 18 or older
6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
7. Absolute neutrophil count ANC ≥1000/μL
8. Platelet count ≥75,000/μL
9. Absolute lymphocyte count ≥100/μL
10. Adequate renal, hepatic, pulmonary and cardiac function defined as:
1. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min
2. Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤2.5 upper limit of normal (ULN)
3. Total bilirubin ≤1.5 mg/dL, except in subjects with Gilbert's syndrome.
4. Cardiac ejection fraction ≥ 50% and no evidence of pericardial effusion within 180 days provide the subject did not receive an anthracycline based treatment or experience a cardiac event or change in performance status
5. No clinically significant pleural effusion
6. Baseline oxygen saturation \>92% on room air
Exclusion Criteria
2. History of allogeneic stem cell transplantation (SCT)
3. Prior CD19 targeted therapy
4. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
5. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
6. Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite Pharma Medical Monitor
7. History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or hepatitis C infection. Subjects with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines
8. History or presence of primary CNS lymphoma and/or CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
18 Years
ALL
No
Sponsors
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Kite, A Gilead Company
INDUSTRY
Responsible Party
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Principal Investigators
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Kite Study Director
Role: STUDY_DIRECTOR
Kite, A Gilead Company
Locations
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City of Hope
Duarte, California, United States
Stanford Cancer Institute
Stanford, California, United States
University of Miami Hospital and Clinics
Miami, Florida, United States
H. Lee Moffitt Cancer and Research Institute
Tampa, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
The University of Kansas Hospital Investigational Drug Services
Westwood, Kansas, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2015-005007-86
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KTE-C19-109
Identifier Type: -
Identifier Source: org_study_id
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