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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: Recruiting 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.
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, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage of pts with listed categories: New secondary malignancies, new serious infection, new incidence of serious neurologic disorder, New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, New incidence of a hematologic disorder
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 |
What NCT02445222 shows while recruiting
NCT02445222 is an interventional study that assigns participants to a tested intervention. Its 1,400 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% higher).
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 names 20 study sites across 7 states, led by 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
How this trial's enrollment target compares
Where NCT02445222's enrollment target sits among peer trials
1,400 172nd of 2000 higher than 1,827 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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