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RECRUITING Phase 3 ClinicalTrials.gov

CAR-T Long Term Follow Up (LTFU) Study

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT02445222

Registry updated: 2026-10-02
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Description

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.

Interventions

  • Previously treated CAR-T patients (Genetic)
    Lentiviral-based CAR-T cell therapy

Eligibility criteria

Inclusion Criteria: * All patients who have received a CAR-T therapy and completed or discontinued early from a Novartis sponsored treatment protocol that utilized CAR-T cells or from any CAR-T trial sponsored by the University of Pennsylvania with which Novartis has a contractual agreement to co-develop the CAR technology. * Patients who have provided informed consent for the long term follow up study prior to their study participation . Exclusion Criteria: * There are no specific exclusion criteria for this study.

Conditions

Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

Locations

  • 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
  • Tennessee Oncology — 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 — 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 — Paris, France
  • Novartis Investigative Site — Pessac, France
  • Novartis Investigative Site — Pierre-Bénite, France
  • Novartis Investigative Site — Strasbourg, 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 — Sapporo, Hokkaido, Japan
  • Novartis Investigative Site — Sendai, Miyagi, Japan
  • Novartis Investigative Site — Chuo Ku, Tokyo, Japan
  • Novartis Investigative Site — Fukuoka, 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 — Pamplona, Navarre, Spain
  • Novartis Investigative Site — Barcelona, Spain
  • Novartis Investigative Site — Barcelona, Spain
  • Novartis Investigative Site — Madrid, Spain
  • Novartis Investigative Site — Madrid, Spain
  • Novartis Investigative Site — Madrid, Spain
  • Novartis Investigative Site — Salamanca, Spain
  • Novartis Investigative Site — Seville, Spain
  • Novartis Investigative Site — Valencia, Spain
  • Novartis Investigative Site — Taipei, Taiwan
  • Novartis Investigative Site — Birmingham, West Midlands, United Kingdom
  • Novartis Investigative Site — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record