The goal of this study is to provide access to axicabtagene ciloleucel for patientsdiagnosed with a disease approved for treatment with axicabtagene ciloleucel, that isotherwise out of specification for commercial release.
Not Provided
Drug: Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg
administered intravenously.
Other Name: Yescarta®
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764, United States
Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752, United States
City of Hope Medical Center
Duarte 5344147, California 5332921, United States
Colorado Blood Cancer Institute
Denver 5419384, Colorado 5417618, United States
Mayo Clinic Florida
Jacksonville 4160021, Florida 4155751, United States
Winship Cancer Institute
Atlanta 4180439, Georgia 4197000, United States
Northside Hospital
Atlanta 4180439, Georgia 4197000, United States
St. Luke's Cancer Institute
Boise 5586437, Idaho 5596512, United States
Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861, United States
The University of Kansas Medical Center
Westwood 4281639, Kansas 4273857, United States
University of Maryland Cancer Center
Baltimore 4347778, Maryland 4361885, United States
Johns Hopkins Hospital
Baltimore 4347778, Maryland 4361885, United States
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926, United States
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926, United States
Dana Farber Cancer Institute - Chestnut Hill
Boston 4930956, Massachusetts 6254926, United States
University of Michigan
Ann Arbor 4984247, Michigan 5001836, United States
Mayo Clinic
Rochester 5043473, Minnesota 5037779, United States
Washington University School of Medicine- Siteman Cancer Center
St Louis 4407066, Missouri 4398678, United States
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760, United States
Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638, United States
Weill Cornell Medicine - NewYork-Presbyterian Hospital
New York 5128581, New York 5128638, United States
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638, United States
University of Rochester Medical Center
Rochester 5134086, New York 5128638, United States
Montefiore Medical Center (MMC)
The Bronx 5110266, New York 5128638, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348, United States
Cleveland Clinic
Cleveland 5150529, Ohio 5165418, United States
The Ohio State University Wexner Medical Center- James Cancer Hospital
Columbus 4509177, Ohio 5165418, United States
Oregon Health & Science University
Portland 5746545, Oregon 5744337, United States
Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927, United States
Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927, United States
UPMC Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927, United States
Avera Cancer Institute
Sioux Falls 5231851, South Dakota 5769223, United States
Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168, United States
Tennessee Oncology
Nashville 4644585, Tennessee 4662168, United States
Vanderbilt-Ingrim Cancer Center
Nashville 4644585, Tennessee 4662168, United States
Baylor University Medical Center
Dallas 4684888, Texas 4736286, United States
Houston Methodist Hospital
Houston 4699066, Texas 4736286, United States
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286, United States
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio 4726206, Texas 4736286, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City 5780993, Utah 5549030, United States
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928, United States
Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135, United States
West Virginia University
Morgantown 4815352, West Virginia 4826850, United States
Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468, United States
Anjo Kosei Hospital
Aichi 11192139, Japan
Nagoya Medical Center
Aichi 11192139, Japan
Aichi Medical University Hospital
Aichi 11192139, Japan
Akita University Hospital
Akita 2113126, Japan
Chiba University Hospital
Chiba 2113015, Japan
Ehime University Hospital
Ehime, Japan
University of Fukui Hospital
Fukui 1863986, Japan
Kokura Kinen Hospital
Fukuoka 1863967, Japan
Hamanomachi Hospital
Fukuoka 1863967, Japan
Kyushu Medical Center
Fukuoka 1863967, Japan
Kyushu University Hospital
Fukuoka 1863967, Japan
Kurume University Hospital
Fukuoka 1863967, Japan
Gifu Municipal Hospital
Gifu 1863641, Japan
Gunma University Hospital
Gunma, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima 1862415, Japan
Hiroshima University Hospital
Hiroshima 1862415, Japan
Hokkaido University Hospital
Hokkaido, Japan
Kobe University Hospital
Hyōgo 2129969, Japan
Kobe City Medical Center General Hospital
Hyōgo 2129969, Japan
Hyogo Medical University Hospital
Hyōgo 2129969, Japan
University of Tsukuba Hospital
Ibaraki 1862033, Japan
Kagawa University Hospital
Kagawa 1860837, Japan
Kagoshima University Hospital
Kagoshima 1860827, Japan
Yokohama City University Medical Center
Kanagawa 1860292, Japan
Yokohama City University Hospital
Kanagawa 1860292, Japan
Kanazawa University Hospital
Kanazawa 1860243, Japan
Kumamoto University Hospital
Kumamoto 1858421, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto 1857910, Japan
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto 1857910, Japan
Kyoto University Hospital
Kyoto 1857910, Japan
Mie University Hospital
Mie 1857357, Japan
Tohoku University Hospital
Miyagi 1856813, Japan
University of Miyazaki Hospital
Miyazaki 1856717, Japan
Shinshu University Hospital
Nagano 1856215, Japan
Nagasaki University Hospital
Nagasaki 1856177, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya 1856057, Japan
Nagoya University Hospital
Nagoya 1856057, Japan
Niigata University Medical & Dental Hospital
Niigata 1855431, Japan
Okayama University Hospital
Okayama 1854383, Japan
Kurashiki Central Hospital
Okayama 1854383, Japan
Univercity of the Ryukyus Hospital
Okinawa 1894616, Japan
Osaka International Cancer Institute
Osaka 1853909, Japan
Osaka Red Cross Hospital
Osaka 1853909, Japan
The University of Osaka Hospital
Osaka 1853909, Japan
Kansai Medical University Hospital
Osaka 1853909, Japan
Kindai University Hospital
Osaka 1853909, Japan
Oita University Hospital
Ōita 1854487, Japan
Jichi Medical University Saitama Medical Center
Saitama 6940394, Japan
Saitama Medical Center
Saitama 6940394, Japan
Shiga University of Medical Science Hospital
Shiga 9115498, Japan
Shimane University Hospital
Shimane 10987750, Japan
Hamamatsu University Hospital
Shizuoka 1851717, Japan
Jichi Medical University Hospital
Tochigi 1850311, Japan
Tokushima University Hospital
Tokushima 1850158, Japan
National Cancer Center Hospital
Tokyo 1850147, Japan
Toranomon Hospital
Tokyo 1850147, Japan
Jikei University Hospital
Tokyo 1850147, Japan
Juntendo University School of Medicine Juntendo Clinic
Tokyo 1850147, Japan
Institute of Science Tokyo Hospital
Tokyo 1850147, Japan
The University of Tokyo Hospital
Tokyo 1850147, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo 1850147, Japan
Keio University Hospital
Tokyo 1850147, Japan
Teikyo University Hospital
Tokyo 1850147, Japan
Nihon University Itabashi Hospital
Tokyo 1850147, Japan
Tottori Univeristy Hospital
Tottori 1849893, Japan
Wakayama Medical University Hospital
Wakayama 1926004, Japan
Yamagata University Hospital
Yamagata 2110556, Japan
Yamaguchi University Hospital
Yamaguchi 1848689, Japan
Medical Information
844-454-5483(1-844-454-KITE)
medinfo@kitepharma.com
Kite Study Director, Study Director
Kite, A Gilead Company