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CAR-T Long Term Follow Up (LTFU) Study
Recruiting
Trial ID: NCT02445222
Purpose
Per Health Authorities guidelines for gene therapy medicinal products that utilize
integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of
treated patients is required. The purpose of this study is to monitor all patients exposed to
CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the
risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and
assess long-term efficacy, including vector persistence.
Official Title
Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- All patients who have received a CAR-T therapy and completed or discontinued early
from a Novartis sponsored treatment protocol that utilized CAR-T cells or from any
CAR-T trial sponsored by the University of Pennsylvania with which Novartis has a
contractual agreement to co-develop the CAR technology.
- Patients who have provided informed consent for the long term follow up study prior to
their study participation .
Exclusion Criteria:
- There are no specific exclusion criteria for this study.
Intervention(s):
genetic: Previously treated CAR-T patients
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305