CAR-T Long Term Follow Up (LTFU) Study

Trial ID or NCT#

NCT02445222

Status

recruiting iconRECRUITING

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

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * There are no specific exclusion criteria for this study.
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Investigator(s)

Kara Davis

View on ClinicalTrials.gov