Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02445222 · ClinicalTrials.gov registry record · Phase 3
CAR-T Long Term Follow Up (LTFU) Study
A Phase 3 study of Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,400
- Enrollment target
- 20
- Study locations
NCT02445222 is a Phase 3 study of Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 1,400 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT02445222, a Phase 3 study of Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,400 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,400 participants |
| Start Date | 2015-11-02 |
| Est. Completion | 2036-02-22 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. 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 1,375 total studies on file at ClinicalTrials.gov.
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.
NCT02445222 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Michigan, Georgia.
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.
What interventions are being tested in trial NCT02445222?
The interventions under investigation include: Previously treated CAR-T patients (GENETIC).
Who is sponsoring clinical trial NCT02445222?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.