Clinical trial NCT05776160: Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Official title: Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Large B-cell Lymphoma
Follicular Lymphoma
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2023-03-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Boise
country: United States
facility: St. Luke's Cancer Institute
state: Idaho
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Westwood
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Cancer Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute - Chestnut Hill
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine- Siteman Cancer Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center (MMC)
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine - NewYork-Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals, The University of North Carolina at Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center- James Cancer Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingrim Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare System of San Antonio dba Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute, University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Aichi
country: Japan
facility: Nagoya Medical Center
city: Akita
country: Japan
facility: Akita University Hospital
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chuo-ku
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Ehime
country: Japan
facility: Ehime University Hospital
city: Fukuokaken
country: Japan
facility: Hamanomachi Hospital
city: Fukuoka
country: Japan
facility: Kyushu Medical Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Gifu
country: Japan
facility: Gifu Municipal Hospital
city: Gunma
country: Japan
facility: Gunma University Hospital
city: Higashiyama-ku
country: Japan
facility: Japanese Red Cross Kyoto Daiichi Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hyogo
country: Japan
facility: Kobe University Hospital
city: Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Itabashi-Ku
country: Japan
facility: Teikyo University Hospital
city: Kagawa
country: Japan
facility: Kagawa University Hospital
city: Kagoshimaken
country: Japan
facility: Kagoshima University Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kokurakita-ku
country: Japan
facility: Kokura Kinen Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Mie
country: Japan
facility: Mie University Hospital
city: Miyagi
country: Japan
facility: Tohoku University Hospital
city: Miyazaki City
country: Japan
facility: University of Miyazaki Hospital
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
city: Nagano
country: Japan
facility: Shinshu University Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Nakagami-gun
country: Japan
facility: Univercity of the Ryukyus Hospital
city: Oita
country: Japan
facility: Oita University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Okayama
country: Japan
facility: Kurashiki Central Hospital
city: Osaka-shi
country: Japan
facility: Osaka Red Cross Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Kansai Medical University Hospital
city: Osaka
country: Japan
facility: Kindai University Hospital
city: Saitama
country: Japan
facility: Jichi Medical University Saitama Medical Center
city: Sapporo Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Shiga
country: Japan
facility: Shiga University of Medical Science Hospital
city: Shimane
country: Japan
facility: Shimane University Hospital
city: Shizuoka
country: Japan
facility: Hamamatsu University Hospital
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: Jikei University Hospital
city: Tokyo
country: Japan
facility: Juntendo University School of Medicine Juntendo Clinic
city: Tokyo
country: Japan
facility: The University of Tokyo Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hospital
city: Ube City
country: Japan
facility: Yamaguchi University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
city: Yonago-shi
country: Japan
facility: Tottori Univeristy Hospital
Study officials:
affiliation: Kite, A Gilead Company
name: Kite Study Director
role: STUDY_DIRECTOR
References: