Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria
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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)
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Deemed medically fit and stable to receive the product per the investigator's evaluation
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Repeat leukapheresis is not feasible per the investigator's assessment
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Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release
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In the investigator's opinion, there is no satisfactory alternative therapy available to the individual
Exclusion Criteria:
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History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel
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Uncontrolled active infection or inflammation per physician assessment
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Primary central nervous system lymphoma
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kite, A Gilead Company
Investigators
- Study Director: Kite Study Director, Kite, A Gilead Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KT-US-471-0140