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CAR-T Long Term Follow Up (LTFU) Study
Sponsor: Novartis Pharmaceuticals
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.
Official title: Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
Key Details
Gender
All
Age Range
0 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
1400
Start Date
2015-11-02
Completion Date
2036-02-22
Last Updated
2025-10-28
Healthy Volunteers
No
Conditions
Interventions
Previously treated CAR-T patients
Lentiviral-based CAR-T cell therapy
Locations (118)
Mayo Clinic Arizona
Phoenix, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
UCSF Medical Center
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia, United States
Emory University School of Medicine/Winship Cancer Institute
Atlanta, Georgia, United States
Childrens Healthcare of Atlanta
Atlanta, Georgia, United States
Uni of Chi Medi Ctr Hema and Onco
Chicago, Illinois, United States
University of Chicago Medical Center, Hematology & Oncology
Chicago, Illinois, United States
University of Kansas Cancer Center SC
Westwood, Kansas, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Med Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Uni Of Michigan Health System
Ann Arbor, Michigan, United States
University of Michigan Health System SC CTL019
Ann Arbor, Michigan, United States
Wayne State University-Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Children s Mercy Hospital
Kansas City, Missouri, United States
Children's Mercy Hospital SC
Kansas City, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
Duke Unversity Medical Center SC - CTL019B2205J
Durham, North Carolina, United States
Duke Unversity Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cinn Children Hosp Medical Center
Cincinnati, Ohio, United States
Ohio ST Compr Cancer Ctr James Hosp
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Oregon Health Sciences University
Portland, Oregon, United States
The Childrens Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
UTSW/Children's Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center SC
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Utah Clinical Trials Office
Salt Lake City, Utah, United States
University of Utah Clinical Trials Office
Salt Lake City, Utah, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
Novartis Investigative Site
Camperdown, New South Wales, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Murdoch, Western Australia, Australia
Novartis Investigative Site
Herston, Australia
Novartis Investigative Site
Linz, Austria
Novartis Investigative Site
Salzburg, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Ghent, Belgium
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Copenhagen, Denmark
Novartis Investigative Site
Helsinki, Finland
Novartis Investigative Site
Nantes, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Pierre-Bénite, France
Novartis Investigative Site
Villejuif, France
Novartis Investigative Site
Munich, Bavaria, Germany
Novartis Investigative Site
Regensburg, Bavaria, Germany
Novartis Investigative Site
Würzburg, Bavaria, Germany
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
Novartis Investigative Site
Leipzig, Saxony, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Chaïdári, Greece
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Ramat Gan, Israel
Novartis Investigative Site
Tel Aviv, Israel
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Monza, MB, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Sendai, Miyagi, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Novartis Investigative Site
Kyoto, Japan
Novartis Investigative Site
Amsterdam, North Holland, Netherlands
Novartis Investigative Site
Utrecht, Netherlands
Novartis Investigative Site
Utrecht, Netherlands
Novartis Investigative Site
Oslo, Norway
Novartis Investigative Site
Oslo, Norway
Novartis Investigative Site
Riyadh, Saudi Arabia
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Esplugues, Barcelona, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Salamanca, Castille and León, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Pamplona, Navarre, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Seville, Spain
Novartis Investigative Site
Valencia, Spain
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Birmingham, United Kingdom
Novartis Investigative Site
London, United Kingdom