CAR-T Long Term Follow Up (LTFU) Study
0 Years and older, Male and Female
CCTL019A2205B (primary)
NCI-2015-01238
2014-001673-14
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.
Eligibility
- 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 .
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.