UPCC 43914 Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 directed CART Cell Therapy (PAVO)

Investigation of Long-Term Safety and Efficacy in CAR-T Therapy Patients

Enrolling By Invitation
100 years or below
All
Phase 3
1400 participants needed
1 Location

Brief description of study

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.

Detailed description of study

Patients are enrolled following completion or early discontinuation from a Novartis sponsored or supported study of CAR T-Cell treatment. Patients will be followed for 15 years post treatment from the last treatment. They will be monitored for safety and efficacy within the primary treatment protocols for the protocol defined duration. Patients can drop off treatment protocols at any time to enter this long term Follow up study. 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 CAR-T therapy within the concept of a single protocol.

Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
  • Age: 100 years or below
  • Gender: All

Inclusion Criteria:

  • All patients who have received a CAR-T therapy and completed or discontinued early from a Novartis sponsored treatment protocol that utilized CAR-T cells or from any CAR-T 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.

This study investigates the long-term safety and efficacy of patients who have undergone CAR-T cell therapy. The purpose of this study is to monitor these patients for 15 years following their last CAR-T infusion to assess any delayed adverse events, check for replication competent lentivirus, and evaluate long-term efficacy, including the persistence of the vector used in the therapy.

Participants will be enrolled after completing or discontinuing a prior CAR-T cell treatment study. They will be monitored for safety and efficacy as per the primary treatment protocols. This long-term follow-up will allow researchers to collect data on the long-term effects of CAR-T cell therapy, which is important for understanding the overall risk-benefit profile of such treatments.

  • Who can participate: Patients who have received CAR-T therapy and completed or discontinued early from a related treatment protocol are eligible. Informed consent for the long-term follow-up study is required.
  • Study details: Participants will be monitored for long-term safety and efficacy following their CAR-T therapy. This involves regular assessments to check for any delayed adverse events and the persistence of the therapy's effects.
  • Study timelines: The study will last 15 years.
Updated on 28 Oct 2025. Study ID: 15-0124
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