Trial Title:
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
NCT ID:
NCT05776160
Condition:
Large B-cell Lymphoma
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Axicabtagene ciloleucel
Study type:
Expanded Access
Overall status:
Available
Intervention:
Intervention type:
Drug
Intervention name:
Axicabtagene Ciloleucel
Description:
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg
administered intravenously.
Other name:
Yescarta®
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Available
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Available
Facility:
Name:
Colorado Blood Cancer Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Available
Facility:
Name:
Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Available
Facility:
Name:
Northwestern Memorial Hospital
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Available
Facility:
Name:
The University of Kansas Medical Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Available
Facility:
Name:
University of Maryland Cancer Center
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Status:
Available
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Available
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Available
Facility:
Name:
Dana Farber Cancer Institute - Chestnut Hill
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Available
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Available
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55902
Country:
United States
Status:
Available
Facility:
Name:
Washington University School of Medicine- Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Available
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Available
Facility:
Name:
UNC Hospitals, The University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Available
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Available
Facility:
Name:
The Ohio State University Wexner Medical Center- James Cancer Hospital
Address:
City:
Columbus
Zip:
43201
Country:
United States
Status:
Available
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Available
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Available
Facility:
Name:
Avera Cancer Institute
Address:
City:
Sioux Falls
Zip:
57105
Country:
United States
Status:
Available
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Available
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Available
Facility:
Name:
Methodist Healthcare System of San Antonio dba Methodist Hospital
Address:
City:
San Antonio
Zip:
782229
Country:
United States
Status:
Available
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Available
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Available
Facility:
Name:
Tokyo Medical And Dental University Hospital
Address:
City:
Bunkyo-ku
Zip:
113-8519
Country:
Japan
Status:
Available
Facility:
Name:
Chiba University Hospital
Address:
City:
Chiba
Zip:
260-8677
Country:
Japan
Status:
Available
Facility:
Name:
Hamanomachi Hospital
Address:
City:
Fukuokaken
Zip:
810-0072
Country:
Japan
Status:
Available
Facility:
Name:
Gifu Municipal Hospital
Address:
City:
Gifu
Zip:
500-8513
Country:
Japan
Status:
Available
Facility:
Name:
Kobe City Medical Center General Hospital
Address:
City:
Hyogo
Zip:
650-0047
Country:
Japan
Status:
Available
Facility:
Name:
Hyogo Medical University Hospital
Address:
City:
Hyogo
Zip:
663-8501
Country:
Japan
Status:
Available
Facility:
Name:
University of Tsukuba Hospital
Address:
City:
Ibaraki
Zip:
305-8576
Country:
Japan
Status:
Available
Facility:
Name:
Kanazawa University Hospital
Address:
City:
Kanazawa
Zip:
920-8641
Country:
Japan
Status:
Available
Facility:
Name:
Kumamoto University Hospital
Address:
City:
Kumamoto
Zip:
860-8556
Country:
Japan
Status:
Available
Facility:
Name:
University Hospital Kyoto Prefectural University of Medicine
Address:
City:
Kyoto
Zip:
602-8566,
Country:
Japan
Status:
Available
Facility:
Name:
Kyoto University Hospital
Address:
City:
Kyoto
Zip:
606-8507
Country:
Japan
Status:
Available
Facility:
Name:
Tohoku University Hospital
Address:
City:
Miyagi
Zip:
980-8574
Country:
Japan
Status:
Available
Facility:
Name:
Shinshu University Hospital
Address:
City:
Nagano
Zip:
390-8621
Country:
Japan
Status:
Available
Facility:
Name:
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Address:
City:
Nagoya
Zip:
4538511
Country:
Japan
Status:
Available
Facility:
Name:
Nagoya University Hospital
Address:
City:
Nagoya
Zip:
466-8560
Country:
Japan
Status:
Available
Facility:
Name:
Kurashiki Central Hospital
Address:
City:
Okayama
Zip:
7108602
Country:
Japan
Status:
Available
Facility:
Name:
Osaka University Hospital
Address:
City:
Osaka
Zip:
565-0871
Country:
Japan
Status:
Available
Facility:
Name:
Kansai Medical University Hospital
Address:
City:
Osaka
Zip:
573-1191
Country:
Japan
Status:
Available
Facility:
Name:
Kindai University Hospital
Address:
City:
Osaka
Zip:
589-8511
Country:
Japan
Status:
Available
Facility:
Name:
Hokkaido University Hospital
Address:
City:
Sapporo Hokkaido
Zip:
060-8648
Country:
Japan
Status:
Available
Facility:
Name:
Hamamatsu University Hospital
Address:
City:
Shizuoka
Zip:
431-3192
Country:
Japan
Status:
Available
Facility:
Name:
Jichi Medical University Hospital
Address:
City:
Tochigi
Zip:
329-0498
Country:
Japan
Status:
Available
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Status:
Available
Facility:
Name:
Toranomon Hospital
Address:
City:
Tokyo
Zip:
105-8470
Country:
Japan
Status:
Available
Facility:
Name:
Jikei University Hospital
Address:
City:
Tokyo
Zip:
105-8471
Country:
Japan
Status:
Available
Facility:
Name:
Juntendo University School of Medicine Juntendo Clinic
Address:
City:
Tokyo
Zip:
113-8431
Country:
Japan
Status:
Available
Facility:
Name:
The University of Tokyo Hospital
Address:
City:
Tokyo
Zip:
113-8655
Country:
Japan
Status:
Available
Facility:
Name:
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Address:
City:
Tokyo
Zip:
113-8677
Country:
Japan
Status:
Available
Facility:
Name:
Keio University Hospital
Address:
City:
Tokyo
Zip:
160-8582
Country:
Japan
Status:
Available
Facility:
Name:
Yamagata University Hospital
Address:
City:
Yamagata
Zip:
990-9585
Country:
Japan
Status:
Available
Facility:
Name:
Yokohama City University Hospital
Address:
City:
Yokohama
Zip:
236-0004
Country:
Japan
Status:
Available
Lead sponsor:
Agency:
Kite, A Gilead Company
Agency class:
Industry
Source:
Gilead Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05776160
https://www.gileadclinicaltrials.com/study?nctid=NCT05776160
