CAR-T Long Term Follow Up (LTFU) Study

Active:	Yes
Cancer Type:	Unknown Primary	NCT ID:	NCT02445222
Trial Phases:	Phase III	Protocol IDs:	CCTL019A2205B (primary) NCI-2015-01238 2014-001673-14
Eligibility:	0 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Novartis Pharmaceuticals Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT02445222

Summary

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.

Objectives

Patients are enrolled following completion or early discontinuation from a Novartis sponsored
or supported study of CAR T-Cell treatment. Patients will be followed for 15 years post
treatment from the last treatment. They will be monitored for safety and efficacy within the
primary treatment protocols for the protocol defined duration. Patients can drop off
treatment protocols at any time to enter this long term Follow up study. Patients
discontinuing from the primary treatment protocols for any reason will be enrolled in this
long term follow up (LTFU). This will allow collecting data on long term safety and efficacy
(as applicable) as mandated by the health authorities of all patients treated with CAR-T
therapy within the concept of a single protocol.

Collection of such long term effects of CAR-T cell therapy will help to further define the
risk-benefit profile of CAR-T Therapies.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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