CAR-T Long Term Follow Up (LTFU) Study (PAVO)

Novartis

Status and phase: Enrolling; Phase 3

Conditions: Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

Treatments: Genetic: Previously treated CAR-T patients

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02445222

2014-001673-14 (EudraCT Number)

CCTL019A2205B

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,400 participants in 1 patient group

Previously treated CAR-T patients

Other group

Description:

Patients who previously were exposed to lentiviral-based CART cell therapy

Treatment:

Genetic: Previously treated CAR-T patients