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RECRUITING
NCT02445222
PHASE3

CAR-T Long Term Follow Up (LTFU) Study

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

GENETIC

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