NCT02445222
CAR-T Long Term Follow Up (LTFU) Study
RecruitingPHASE3
Study 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.
At a glance
- Conditions
- Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
- Interventions
- Previously treated CAR-T patients
- Lead sponsor
- Novartis Pharmaceuticals
- Target enrollment
- 1105 participants
- Age
- 0 Years – 100 Years
- Sex
- ALL
- Locations
- Novartis Investigative Site
- Registry
- View on ClinicalTrials.gov ↗
Eligibility criteria
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.