Clinical TrialsThe James Cancer Center Columbus, OH
open for enrollment
CD19 CART Long Term Follow Up (LTFU) Study
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.
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?
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 .
There are no specific exclusion criteria for this study.