CAR-T Long Term Follow Up (LTFU) Study

Conditions

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

Eligibility Criteria

Sex

ALL

Age

0 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Previously treated CAR-T patients — GENETIC
  Lentiviral-based CAR-T cell therapy

Study Details

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.

Key Dates

Start date

Nov 2, 2015

Status verified

Oct 2025

Primary completion

Feb 22, 2036

Completion

Feb 22, 2036

Study Design

Enrollment

1,400 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Other: Previously treated CAR-T patients
  Patients who previously were exposed to lentiviral-based CART cell therapy

Primary Outcome Measure

Percentage of patients with certain events (see description) [ Time Frame: at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15. ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
• Novartis Pharmaceuticals
  +41613241111

Locations (44)

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