Study Details

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.

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

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 (56)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

City of Hope Medical Center

Duarte, California, United States, 91010

Colorado Blood Cancer Institute

Denver, Colorado, United States, 80218

Winship Cancer Institute

Atlanta, Georgia, United States, 30322

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

University of Michigan

Ann Arbor, Michigan, United States, 48109

Mayo Clinic

Rochester, Minnesota, United States, 55902

Washington University School of Medicine- Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27514

Cleveland Clinic

Cleveland, Ohio, United States, 44195

The Ohio State University Wexner Medical Center- James Cancer Hospital

Columbus, Ohio, United States, 43201

Oregon Health & Science University

Portland, Oregon, United States, 97239

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

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

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Tokyo Medical And Dental University Hospital

Bunkyo-ku, Japan, 113-8519

Chiba University Hospital

Chiba, Japan, 260-8677

Hamanomachi Hospital

Fukuokaken, Japan, 810-0072

Gifu Municipal Hospital

Gifu, Japan, 500-8513

Kobe City Medical Center General Hospital

Hyogo, Japan, 650-0047

Hyogo Medical University Hospital

Hyogo, Japan, 663-8501

University of Tsukuba Hospital

Ibaraki, Japan, 305-8576

Kanazawa University Hospital

Kanazawa, Japan, 920-8641

Kumamoto University Hospital

Kumamoto, Japan, 860-8556

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan, 602-8566,

Kyoto University Hospital

Kyoto, Japan, 606-8507

Tohoku University Hospital

Miyagi, Japan, 980-8574

Shinshu University Hospital

Nagano, Japan, 390-8621

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

Nagoya, Japan, 4538511

Nagoya University Hospital

Nagoya, Japan, 466-8560

Kurashiki Central Hospital

Okayama, Japan, 7108602

Osaka University Hospital

Osaka, Japan, 565-0871

Kansai Medical University Hospital

Osaka, Japan, 573-1191

Kindai University Hospital

Osaka, Japan, 589-8511

Hokkaido University Hospital

Sapporo Hokkaido, Japan, 060-8648

Hamamatsu University Hospital

Shizuoka, Japan, 431-3192

Jichi Medical University Hospital

Tochigi, Japan, 329-0498

National Cancer Center Hospital

Tokyo, Japan, 104-0045

Toranomon Hospital

Tokyo, Japan, 105-8470

Jikei University Hospital

Tokyo, Japan, 105-8471

Juntendo University School of Medicine Juntendo Clinic

Tokyo, Japan, 113-8431

The University of Tokyo Hospital

Tokyo, Japan, 113-8655

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Tokyo, Japan, 113-8677

Keio University Hospital

Tokyo, Japan, 160-8582

Yamagata University Hospital

Yamagata, Japan, 990-9585

Yokohama City University Hospital

Yokohama, Japan, 236-0004

Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel

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