Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

CD19 CART Long Term Follow Up (LTFU) Study

Protocol: OSU-15042

Full Title

Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 directed CART Cell Therapy


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 CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (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.

Study Objective

Patients are enrolled following completion or early discontinuation from a Novartis

sponsored or supported study of CD19 directed CAR T-Cell treatment and will be followed for

15 years post treatment from the last CD19 directed CAR T-Cell treatment. Patients will be

monitored for safety and efficacy within the primary treatment protocols for the protocol

defined duration. While every effort will be made to keep patients in follow-up within the

respective treatment protocol itself, patients can drop off treatment protocols at any time.

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

CD19 CART therapy within the concept of a single protocol.

Collection of such long term effects of CD19 CART cell therapy will help to further define

the risk-benefit profile of CD19 CART.

Are you eligible?

Inclusion Criteria:

All patients who have received anti-CD19 directed CART therapy and completed or

discontinued early from a Novartis sponsored treatment protocol that utilized

CD19-directed CART cells or from any CD19 CART trial sponsored by the University of

Pennsylvania with which Novartis has a contractual agreement to co-develop the CAR


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.