CAR-T Long Term Follow Up (LTFU) Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Previously treated CAR-T patients: Lentiviral-based CAR-T cell therapy

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.

Eligibility

Primary outcome measure(s)

• Percentage of patients with certain events (see description) — at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15.
  The percentage of pts with listed categories: New secondary malignancies, new serious infection, new incidence of serious neurologic disorder, New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, New incidence of a hematologic disorder

Trial sites (118)

+ 78 more sites — see the full list on the official registry below.

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