CD19 CART Long Term Follow Up (LTFU) Study

  • Interventional
  • Recruiting
  • NCT02445222
Eligibility Details Visit Clinicaltrials.gov

Long Term Follow-Up of Patients Exposed to Lentiviral-Based 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.

Patients are enrolled following completion or early discontinuation from a Novartis sponsored or supported study of CD19 directed CAR T-Cell treatment and will be followed for 15 years post treatment from the last CD19 directed CAR T-Cell treatment. Patients will be monitored for safety and efficacy within the primary treatment protocols for the protocol defined duration. While every effort will be made to keep patients in follow-up within the respective treatment protocol itself, patients can drop off treatment protocols at any time. Patients discontinuing from the primary treatment protocols for any reason will be enrolled in this long term follow up (LTFU). This will allow collecting data on long term safety and efficacy (as applicable) as mandated by the health authorities of all patients treated with CD19 CART therapy within the concept of a single protocol.

     Collection of such long term effects of CD19 CART cell therapy will help to further define the risk-benefit profile of CD19 CART.

Gender
All

Age Group
Any

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - 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.

         - Patients who have provided informed consent for the long term follow up study prior to their study participation .

        Exclusion Criteria:

         - There are no specific exclusion criteria for this study.

At a Glance

National Government IDNCT02445222

IRB#IRB15-0095

Lead SponsorNovartis Pharmaceuticals

Lead PhysicianMichael R. Bishop

Collaborator(s)N/A

EligibilityAll
Recruiting