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 (106)

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

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

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Northside Hospital

Atlanta, Georgia, United States, 30342

St. Luke's Cancer Institute

Boise, Idaho, United States, 83712

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

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Montefiore Medical Center (MMC)

Bronx, New York, United States, 10467

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

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

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

Houston Methodist Hospital

Houston, Texas, United States, 77030

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

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

Nagoya Medical Center

Aichi, Japan, 460-0001

Akita University Hospital

Akita, Japan, 010-8543

Tokyo Medical And Dental University Hospital

Bunkyo-ku, Japan, 113-8519

Chiba University Hospital

Chiba, Japan, 260-8677

Niigata University Medical & Dental Hospital

Chuo-ku, Japan, 951-8520

Ehime University Hospital

Ehime, Japan, 791-0295

Hamanomachi Hospital

Fukuokaken, Japan, 810-0072

Kyushu Medical Center

Fukuoka, Japan, 810-8563

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Kurume University Hospital

Fukuoka, Japan, 830-0011

Gifu Municipal Hospital

Gifu, Japan, 500-8513

Gunma University Hospital

Gunma, Japan, 371-8511

Japanese Red Cross Kyoto Daiichi Hospital

Higashiyama-ku, Japan, 605-0981

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, Japan, 730-8619

Hiroshima University Hospital

Hiroshima, Japan, 734-8551

Kobe University Hospital

Hyogo, Japan, 650-0017

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

Teikyo University Hospital

Itabashi-Ku, Japan, 173-8606

Kagawa University Hospital

Kagawa, Japan, 761-0793

Kagoshima University Hospital

Kagoshimaken, Japan, 890-0075

Kanazawa University Hospital

Kanazawa, Japan, 920-8641

Kokura Kinen Hospital

Kokurakita-ku, Japan, 802-8555

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

Mie University Hospital

Mie, Japan, 514-8507

Tohoku University Hospital

Miyagi, Japan, 980-8574

University of Miyazaki Hospital

Miyazaki City, Japan, 889-1692

Aichi Medical University Hospital

Nagakute, Japan, 480-1195

Shinshu University Hospital

Nagano, Japan, 390-8621

Nagasaki University Hospital

Nagasaki, Japan, 852-8501

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

Nagoya, Japan, 4538511

Nagoya University Hospital

Nagoya, Japan, 466-8560

Univercity of the Ryukyus Hospital

Nakagami-gun, Japan, 903-0125

Oita University Hospital

Oita, Japan, 879-5593

Okayama University Hospital

Okayama, Japan, 700-8558

Kurashiki Central Hospital

Okayama, Japan, 7108602

Osaka Red Cross Hospital

Osaka-shi, Japan, 543-8555

Osaka International Cancer Institute

Osaka, Japan, 541-8567

Osaka University Hospital

Osaka, Japan, 565-0871

Kansai Medical University Hospital

Osaka, Japan, 573-1191

Kindai University Hospital

Osaka, Japan, 589-8511

Jichi Medical University Saitama Medical Center

Saitama, Japan, 330-8503

Hokkaido University Hospital

Sapporo Hokkaido, Japan, 060-8648

Shiga University of Medical Science Hospital

Shiga, Japan, 520-2192

Shimane University Hospital

Shimane, Japan, 693-8501

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

Nihon University Itabashi Hospital

Tokyo, Japan, 173-8610

Yamaguchi University Hospital

Ube City, Japan, 755-8505

Wakayama Medical University Hospital

Wakayama, Japan, 641-8510

Yamagata University Hospital

Yamagata, Japan, 990-9585

Yokohama City University Medical Center

Yokohama, Japan, 232-0024

Yokohama City University Hospital

Yokohama, Japan, 236-0004

Tottori Univeristy Hospital

Yonago-shi, Japan, 683-8504

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

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