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

Overview

About this study

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 eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Eligibility last updated 5/4/23. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yi Lin, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Madiha Iqbal, M.B.B.S., M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20564174

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