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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

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

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Investigador principal de Mayo Clinic

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

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20564174

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