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

NCT05776160

AvailableN/A

Sponsor: Kite, A Gilead Company

Conditions: Large B-cell Lymphoma, Follicular Lymphoma

Interventions: Axicabtagene Ciloleucel

Countries: United States, Japan

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 overview

Sex: ALL

Age: 18 Years to —

Study type: EXPANDED_ACCESS

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
Locations (128)
  • Birmingham, Alabama, United States
  • Gilbert, Arizona, United States
  • Tucson, Arizona, United States
  • Duarte, California, United States
  • Denver, Colorado, United States
  • Jacksonville, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Boise, Idaho, United States
  • Chicago, Illinois, United States
  • Westwood, Kansas, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • Hackensack, New Jersey, United States
  • Buffalo, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • The Bronx, New York, United States
  • Chapel Hill, North Carolina, United States
  • Cincinnati, Ohio, United States
  • + 98 more on CT.gov