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Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 directed CART Cell Therapy (ADULT)

Primary Investigator
Magenau, John
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT02445222
UM Number
2015.063
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Bone Marrow Transplant
ID (Protocol)
4241
Secondary Protocol No
HUM00101108
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Lymphoid Leukemia
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: Inclusion Criteria
  •   Ages Eligible for Study: Ages Eligible for Study:
  •   Ages Eligible for Study: Child, Adult, Senior
  •   Child, Adult, Senior
  •   All patients who have received anti-CD19 directed CART therapy and completed or discontinued early from a Novartis sponsored treatment protocol that utilized CD19-directed CART cells or from any CD19 CART trial sponsored by the University of Pennsylvania with which Novartis has a contractual agreement to co-develop the CAR technology.
  •   Both
  •   Patients who have provided informed consent for the long term follow up study prior to their study participation .
  •   No
Exclusion Criteria
  •   There are no specific exclusion criteria for this study.