Axicabtagene Ciloleucel Expanded Access Study
ZUMA-9
A Multicenter, Open-label, Expanded Access Study of Axicabtagene Ciloleucel for the Treatment of Subjects With Relapsed/Refractory Large B-cell Lymphoma.
2 other identifiers
expanded_access
N/A
1 country
15
Brief Summary
A multicenter, open-label expanded access protocol for the treatment of subjects with relapsed/refractory large B-cell lymphoma. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
May 15, 2017
CompletedNovember 8, 2023
November 1, 2023
May 11, 2017
November 7, 2023
Conditions
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologically confirmed large B-cell lymphoma, including the following types:
- DLBCL, not otherwise specified
- Primary mediastinal large B-cell lymphoma
- High-grade B-cell lymphoma
- DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL)
- Relapsed or refractory disease, defined as one or more of the following:
- No response to first-line therapy (primary refractory disease); subjects who are intolerant to first-line therapy chemotherapy are excluded OR
- No response or relapse to second or greater lines of therapy OR
- Relapsed after ASCT
- Subjects must have received adequate prior therapy including at a minimum:
- anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and
- an anthracycline containing chemotherapy regimen;
- No evidence, suspicion, and/or history of central nervous system (CNS) involvement of lymphoma
- Age 18 or older
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- +10 more criteria
You may not qualify if:
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
- History of allogeneic stem cell transplantation (SCT)
- Prior CD19 targeted therapy
- Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
- History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
- 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
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
City of Hope
Duarte, California, 91010, United States
Stanford Cancer Institute
Stanford, California, 94305, United States
University of Miami Hospital and Clinics
Miami, Florida, 33136, United States
H. Lee Moffitt Cancer and Research Institute
Tampa, Florida, 33612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
The University of Kansas Hospital Investigational Drug Services
Westwood, Kansas, 66205, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Washington Medical Center
Seattle, Washington, 98109, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kite Study Director
Kite, A Gilead Company
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2017
First Posted
May 15, 2017
Last Updated
November 8, 2023
Record last verified: 2023-11