OVERVIEW
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Large B-cell Lymphoma, Follicular Lymphoma
Gender
N/A
Date
Study Type
Expanded_access
Study Phase
Product
Axicabtagene Ciloleucel
Eligibility information
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
Locations
Locations (128)
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
City of Hope Medical Center
Duarte, California, United States, 91010
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
The University of Kansas Medical Center
Westwood, Kansas, United States, 66205
University of Maryland Cancer Center
Baltimore, Maryland, United States, 21201
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute - Chestnut Hill
Boston, Massachusetts, United States, 02215
Washington University School of Medicine- Siteman Cancer Center
St Louis, Missouri, United States, 63110
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Weill Cornell Medicine - NewYork-Presbyterian Hospital
New York, New York, United States, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
University of Rochester Medical Center
Rochester, New York, United States, 14642
Montefiore Medical Center (MMC)
The Bronx, New York, United States, 10467
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
The Ohio State University Wexner Medical Center- James Cancer Hospital
Columbus, Ohio, United States, 43201
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Oregon Health & Science University
Portland, Oregon, United States, 97239
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingrim Cancer Center
Nashville, Tennessee, United States, 37232
Baylor University Medical Center
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Methodist Healthcare System of San Antonio dba Methodist Hospital
San Antonio, Texas, United States, 782229
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22903
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
West Virginia University
Morgantown, West Virginia, United States, 26506
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Japan, 730-8619
Yokohama City University Medical Center
Kanagawa, Japan, 232-0024
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566,
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, Japan, 4538511
Niigata University Medical & Dental Hospital
Niigata, Japan, 951-8520
Jichi Medical University Saitama Medical Center
Saitama, Japan, 330-8503
Shiga University of Medical Science Hospital
Shiga, Japan, 520-2192
Juntendo University School of Medicine Juntendo Clinic
Tokyo, Japan, 113-8431
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo, Japan, 113-8677
Join Gilead Trial Connect and help advance clinical research. Your participation is key to developing future treatments.
Share Trial