Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 23-004786
- Rochester, Minnesota: 23-004786
NCT ID: NCT05776160
Sponsor Protocol Number: KT-US-471-0140
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 |
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
|
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
|
More information
Publications
Publications are currently not available