Follicular Lymphoma Clinical Trial
Official title:
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
| NCT number | NCT05776160 |
| Other study ID # | KT-US-471-0140 |
| Secondary ID | jRCT2033230370 |
| Status | Available |
| Phase | |
| First received | |
| Last updated |
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.
| Status | Available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Tokyo Medical And Dental University Hospital | Bunkyo-ku | |
| Japan | Chiba University Hospital | Chiba | |
| Japan | Hamanomachi Hospital | Fukuokaken | |
| Japan | Gifu Municipal Hospital | Gifu | |
| Japan | Hyogo Medical University Hospital | Hyogo | |
| Japan | Kobe City Medical Center General Hospital | Hyogo | |
| Japan | University of Tsukuba Hospital | Ibaraki | |
| Japan | Kanazawa University Hospital | Kanazawa | |
| Japan | Kumamoto University Hospital | Kumamoto | |
| Japan | Kyoto University Hospital | Kyoto | |
| Japan | University Hospital Kyoto Prefectural University of Medicine | 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 | Kansai Medical University Hospital | Osaka | |
| Japan | Kindai University Hospital | Osaka | |
| Japan | Osaka University Hospital | Osaka | |
| Japan | Hokkaido University Hospital | Sapporo Hokkaido | |
| Japan | Hamamatsu University Hospital | Shizuoka | |
| Japan | Jichi Medical University Hospital | Tochigi | |
| Japan | Jikei University Hospital | Tokyo | |
| Japan | Juntendo University School of Medicine Juntendo Clinic | Tokyo | |
| Japan | Keio University Hospital | Tokyo | |
| Japan | National Cancer Center Hospital | Tokyo | |
| Japan | The University of Tokyo Hospital | Tokyo | |
| Japan | Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital | Tokyo | |
| Japan | Toranomon Hospital | Tokyo | |
| Japan | Yamagata University Hospital | Yamagata | |
| Japan | Yokohama City University Hospital | Yokohama | |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Winship Cancer Institute | Atlanta | Georgia |
| United States | University of Maryland Cancer Center | Baltimore | Maryland |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Dana Farber Cancer Institute - Chestnut Hill | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | UNC Hospitals, The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | Northwestern Memorial Hospital | Chicago | Illinois |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | The Ohio State University Wexner Medical Center- James Cancer Hospital | Columbus | Ohio |
| United States | Colorado Blood Cancer Institute | Denver | Colorado |
| United States | City of Hope Medical Center | Duarte | California |
| United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
| United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Sarah Cannon Research Institute | Nashville | Tennessee |
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| United States | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Washington University School of Medicine- Siteman Cancer Center | Saint Louis | Missouri |
| United States | Methodist Healthcare System of San Antonio dba Methodist Hospital | San Antonio | Texas |
| United States | Fred Hutchinson Cancer Center | Seattle | Washington |
| United States | Avera Cancer Institute | Sioux Falls | South Dakota |
| United States | The University of Kansas Medical Center | Westwood | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Kite, A Gilead Company |
United States, Japan,
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