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Clinical Trial Details

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Brief Title CD19 CART Long Term Follow Up (LTFU) Study
Official Title Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 Directed CAR T-Cell Therapy
Principal Investigator Bishop, Michael
Brief 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 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.
Gender All
Ages N/A
Enrollment 620
Accepts Healthy Volunteers No
Lead Sponsor Novartis PharmaceuticalsIndustry
Collaborator University of PennsylvaniaOther
Study Design
Study Phase N/A
Study Type Interventional
Contact Name Jose F. Leis
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy
Detail for Health Professional (on clinicaltrials.gov)
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