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Recruiting Phase 3 Interventional

CAR-T Long Term Follow Up (LTFU) Study

ClinicalTrials.gov ID: NCT02445222

Public ClinicalTrials.gov record NCT02445222. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 12:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02445222
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
1,105 participants

Conditions and interventions

Eligibility (public fields only)

Age range
0 Years to 100 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2, 2015 (Actual)
Primary completion
Apr 18, 2039 (Estimated)
Completion
Apr 18, 2039 (Estimated)
Last update posted
Oct 2, 2026

2015 – 2039

United States locations

U.S. sites
42
U.S. states
18
U.S. cities
24
Facility City State ZIP Site status
Mayo Clinic Arizona Phoenix Arizona 85054 Completed
City of Hope National Medical Center Duarte California 91010-3000 Recruiting
Childrens Hospital Los Angeles Los Angeles California 90027 Recruiting
UCLA Medical Center Los Angeles California 90095 Recruiting
UCSF Medical Center San Francisco California 94143 Recruiting
Stanford University Medical Center Stanford California 94304 Recruiting
Emory University School of Medicine-Winship Cancer Institute Atlanta Georgia 30322 Recruiting
Emory University School of Medicine/Winship Cancer Institute Atlanta Georgia 30322 Recruiting
Childrens Healthcare of Atlanta Atlanta Georgia 30342 Recruiting
Uni of Chi Medi Ctr Hema and Onco Chicago Illinois 60637 Recruiting
University of Chicago Medical Center, Hematology & Oncology Chicago Illinois 60637 Recruiting
University of Kansas Cancer Center SC Westwood Kansas 66205 Recruiting
University of Kansas Cancer Center Westwood Kansas 66205 Recruiting
Massachusetts General Hospital Boston Massachusetts 02114 Recruiting
Beth Israel Deaconess Med Center Boston Massachusetts 02215 Recruiting
Dana Farber Cancer Institute Boston Massachusetts 02215 Recruiting
University of Michigan Ann Arbor Michigan 48109-2800 Recruiting
Uni Of Michigan Health System Ann Arbor Michigan 48109 Recruiting
University of Michigan Health System SC CTL019 Ann Arbor Michigan 48109 Recruiting
Wayne State University-Karmanos Cancer Institute Detroit Michigan 48201 Recruiting
University of Minnesota Minneapolis Minnesota 55455 Withdrawn
Children s Mercy Hospital Kansas City Missouri 64108 Recruiting
Children's Mercy Hospital SC Kansas City Missouri 64108 Recruiting
Weill Cornell Medical College New York New York 10065 Withdrawn
Duke Unversity Medical Center SC - CTL019B2205J Durham North Carolina 27705 Recruiting
Duke Unversity Medical Center Durham North Carolina 27705 Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229-3039 Recruiting
Cinn Children Hosp Medical Center Cincinnati Ohio 45229-3039 Recruiting
Ohio ST Compr Cancer Ctr James Hosp Columbus Ohio 43210 Recruiting
Oregon Health & Science University Portland Oregon 97239 Recruiting
Oregon Health Sciences University Portland Oregon 97239 Recruiting
The Childrens Hosp of Philadelphia Philadelphia Pennsylvania 19104 Recruiting
University of Pennsylvania Philadelphia Pennsylvania 19104 Recruiting
Thomas Jefferson University Philadelphia Pennsylvania 19107 Recruiting
Tennessee Oncology Nashville Tennessee 37203 Recruiting
UTSW/Children's Medical Center Dallas Texas 75235 Recruiting
University of Texas Southwestern Medical Center Dallas Texas 75390 Recruiting
MD Anderson Cancer Center SC Houston Texas 77030 Recruiting
MD Anderson Cancer Center Houston Texas 77030 Recruiting
University of Utah Clinical Trials Office Salt Lake City Utah 84108 Recruiting
University of Wisconsin Hospital and Clinics Madison Wisconsin 53792 Recruiting
University of Wisconsin Hospital Madison Wisconsin 53792 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 76 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02445222, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 2, 2026 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02445222 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →