Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
- Conditions
- Large B-cell LymphomaFollicular Lymphoma
- Registration Number
- NCT05776160
- Lead Sponsor
- Kite, A Gilead Company
- Brief Summary
The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria
- Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)
- Deemed medically fit and stable to receive the product per the investigator's evaluation
- Repeat leukapheresis is not feasible per the investigator's assessment
- Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release
- In the investigator's opinion, there is no satisfactory alternative therapy available to the individual
- History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel
- Uncontrolled active infection or inflammation per physician assessment
- Primary central nervous system lymphoma
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (106)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
St. Luke's Cancer Institute
🇺🇸Boise, Idaho, United States
John Theurer Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Montefiore Medical Center (MMC)
🇺🇸Bronx, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Weill Cornell Medicine - NewYork-Presbyterian Hospital
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt-Ingrim Cancer Center
🇺🇸Nashville, Tennessee, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Huntsman Cancer Institute, University of Utah
🇺🇸Salt Lake City, Utah, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Nagoya Medical Center
🇯🇵Aichi, Japan
Akita University Hospital
🇯🇵Akita, Japan
Niigata University Medical & Dental Hospital
🇯🇵Chuo-ku, Japan
Ehime University Hospital
🇯🇵Ehime, Japan
Kyushu Medical Center
🇯🇵Fukuoka, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Kurume University Hospital
🇯🇵Fukuoka, Japan
Gunma University Hospital
🇯🇵Gunma, Japan
Japanese Red Cross Kyoto Daiichi Hospital
🇯🇵Higashiyama-ku, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
🇯🇵Hiroshima, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Kobe University Hospital
🇯🇵Hyogo, Japan
Teikyo University Hospital
🇯🇵Itabashi-Ku, Japan
Kagawa University Hospital
🇯🇵Kagawa, Japan
Kagoshima University Hospital
🇯🇵Kagoshimaken, Japan
Kokura Kinen Hospital
🇯🇵Kokurakita-ku, Japan
Mie University Hospital
🇯🇵Mie, Japan
University of Miyazaki Hospital
🇯🇵Miyazaki City, Japan
Aichi Medical University Hospital
🇯🇵Nagakute, Japan
Nagasaki University Hospital
🇯🇵Nagasaki, Japan
Univercity of the Ryukyus Hospital
🇯🇵Nakagami-gun, Japan
Oita University Hospital
🇯🇵Oita, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Osaka Red Cross Hospital
🇯🇵Osaka-shi, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Jichi Medical University Saitama Medical Center
🇯🇵Saitama, Japan
Shiga University of Medical Science Hospital
🇯🇵Shiga, Japan
Shimane University Hospital
🇯🇵Shimane, Japan
Nihon University Itabashi Hospital
🇯🇵Tokyo, Japan
Yamaguchi University Hospital
🇯🇵Ube City, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Japan
Tottori Univeristy Hospital
🇯🇵Yonago-shi, Japan
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
City of Hope Medical Center
🇺🇸Duarte, California, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
The University of Kansas Medical Center
🇺🇸Westwood, Kansas, United States
University of Maryland Cancer Center
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute - Chestnut Hill
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Washington University School of Medicine- Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center- James Cancer Hospital
🇺🇸Columbus, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
UPMC Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital
🇺🇸San Antonio, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Tokyo Medical And Dental University Hospital
🇯🇵Bunkyo-ku, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Hamanomachi Hospital
🇯🇵Fukuokaken, Japan
Gifu Municipal Hospital
🇯🇵Gifu, Japan
Kobe City Medical Center General Hospital
🇯🇵Hyogo, Japan
Hyogo Medical University Hospital
🇯🇵Hyogo, Japan
University of Tsukuba Hospital
🇯🇵Ibaraki, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Tohoku University Hospital
🇯🇵Miyagi, Japan
Shinshu University Hospital
🇯🇵Nagano, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
🇯🇵Nagoya, Japan
Nagoya University Hospital
🇯🇵Nagoya, Japan
Kurashiki Central Hospital
🇯🇵Okayama, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Kansai Medical University Hospital
🇯🇵Osaka, Japan
Kindai University Hospital
🇯🇵Osaka, Japan
Hokkaido University Hospital
🇯🇵Sapporo Hokkaido, Japan
Hamamatsu University Hospital
🇯🇵Shizuoka, Japan
Jichi Medical University Hospital
🇯🇵Tochigi, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
Toranomon Hospital
🇯🇵Tokyo, Japan
Jikei University Hospital
🇯🇵Tokyo, Japan
Juntendo University School of Medicine Juntendo Clinic
🇯🇵Tokyo, Japan
The University of Tokyo Hospital
🇯🇵Tokyo, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
🇯🇵Tokyo, Japan
Keio University Hospital
🇯🇵Tokyo, Japan
Yamagata University Hospital
🇯🇵Yamagata, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Japan