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RECRUITING Phase 3

CAR-T Long Term Follow Up (LTFU) Study

NCT02445222 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • GENETIC Previously treated CAR-T patients

Study Locations (20)

California

  • City of Hope National Medical Center — Duarte
  • Childrens Hospital Los Angeles — Los Angeles
  • UCLA Medical Center — Los Angeles
  • UCSF Medical Center — San Francisco
  • Stanford University Medical Center — Stanford

Michigan

  • University of Michigan — Ann Arbor
  • Uni Of Michigan Health System — Ann Arbor
  • University of Michigan Health System SC CTL019 — Ann Arbor
  • Wayne State University-Karmanos Cancer Institute — Detroit

Georgia

  • Emory University School of Medicine-Winship Cancer Institute — Atlanta
  • Emory University School of Medicine/Winship Cancer Institute — Atlanta
  • Childrens Healthcare of Atlanta — Atlanta

Massachusetts

  • Massachusetts General Hospital — Boston
  • Beth Israel Deaconess Med Center — Boston
  • Dana Farber Cancer Institute — Boston

Illinois

  • Uni of Chi Medi Ctr Hema and Onco — Chicago
  • University of Chicago Medical Center, Hematology & Oncology — Chicago

Kansas

  • University of Kansas Cancer Center SC — Westwood
  • University of Kansas Cancer Center — Westwood

Arizona

  • Mayo Clinic Arizona — Phoenix

Trial Details

FieldValue
Enrollment Target 1,400 participants
Start Date 2015-11-02
Est. Completion 2036-02-22
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02445222

The ClinicalTrials.gov registry entry for NCT02445222 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program appearing as the primary indexed condition, and to 1 intervention — of which Previously treated CAR-T patients is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02445222 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Michigan, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02445222 about?

NCT02445222 is a clinical study titled "CAR-T Long Term Follow Up (LTFU) 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 foll...

What is the current status of trial NCT02445222?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,400 participants. The study started on 2015-11-02. Estimated completion is 2036-02-22.

What conditions does trial NCT02445222 study?

This clinical trial studies the following conditions: Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02445222?

The interventions under investigation include: Previously treated CAR-T patients (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02445222?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02445222 being conducted?

This trial has 20 study locations across Arizona, California, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial