Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
Novartis Pharmaceuticals
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.
Description
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…
Eligibility
- Age range
- 0–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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: * There are no specific exclusion criteria for this study.
Interventions
- GeneticPreviously treated CAR-T patients
Lentiviral-based CAR-T cell therapy
Locations (118)
- Mayo Clinic ArizonaPhoenix, Arizona
- City of Hope National Medical CenterDuarte, California
- Childrens Hospital Los AngelesLos Angeles, California
- UCLA Medical CenterLos Angeles, California
- UCSF Medical CenterSan Francisco, California
- Stanford University Medical CenterStanford, California