CD19 CART Long Term Follow Up (LTFU) Study
Condition(s)
Leukemia Lymphoma
Leukemia Lymphoma
Age Group
0-9 years 10-17 years 18-26 years 27 years and older
0-9 years 10-17 years 18-26 years 27 years and older
Phase(s)
Other
Other
Genetic
Previously treated CART CD 19 patients
Trial Summary & Details
Ages: Child, Adult, Older Adult
Condition: Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy
Condition: Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy
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 CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (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.