- CAR-T Long Term Follow Up (LTFU) Study — Recruiting • Phase III • Rare Diseases • NCT02445222.
- Study tracking safety and effectiveness of CAR-T cancer therapy in patients for 15 years after treatment to detect delayed problems.
Verify eligibility, endpoints and current status on the original ClinicalTrials.gov registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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. Conditions: Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access…