CAR-T Long Term Follow Up (LTFU) Study


Trial ID: NCT02445222


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)


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.


genetic: Previously treated CAR-T patients


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305