CAR-T Long Term Follow Up (LTFU) Study

Last updated: April 22, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Previously treated CAR-T patients

Clinical Study ID

NCT02445222
CCTL019A2205B
2014-001673-14
  • Ages < 100
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients who have received a CAR-T therapy and completed or discontinued earlyfrom a Novartis sponsored treatment protocol that utilized CAR-T cells or from anyCAR-T trial sponsored by the University of Pennsylvania with which Novartis has acontractual agreement to co-develop the CAR technology.

  • Patients who have provided informed consent for the long term follow up study priorto their study participation .

Exclusion

Exclusion Criteria:

  • There are no specific exclusion criteria for this study.

Study Design

Total Participants: 1400
Treatment Group(s): 1
Primary Treatment: Previously treated CAR-T patients
Phase: 3
Study Start date:
November 02, 2015
Estimated Completion Date:
February 22, 2036

Study Description

Patients are enrolled following completion or early discontinuation from a Novartis sponsored or supported study of CAR T-Cell treatment. Patients will be followed for 15 years post treatment from the last treatment. They will be monitored for safety and efficacy within the primary treatment protocols for the protocol defined duration. Patients can drop off treatment protocols at any time to enter this long term Follow up study. Patients discontinuing from the primary treatment protocols for any reason will be enrolled in this long term follow up (LTFU). This will allow collecting data on long term safety and efficacy (as applicable) as mandated by the health authorities of all patients treated with CAR-T therapy within the concept of a single protocol.

Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies.

Connect with a study center

  • Novartis Investigative Site

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Novartis Investigative Site

    East Melbourne, VIC 3002
    Australia

    Site Not Available

  • Novartis Investigative Site

    Linz, 4020
    Austria

    Site Not Available

  • Novartis Investigative Site

    Vienna, A 1090
    Austria

    Site Not Available

  • Novartis Investigative Site

    Wien, A 1090
    Austria

    Active - Recruiting

  • Novartis Investigative Site

    Gent, 9000
    Belgium

    Active - Recruiting

  • Novartis Investigative Site

    Hamilton, Ontario L8V 1C3
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Montreal, Quebec H1T 2M4
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Copenhagen, DK-2100
    Denmark

    Active - Recruiting

  • Novartis Investigative Site

    Helsinki, 00029
    Finland

    Active - Recruiting

  • Novartis Investigative Site

    Paris, 75019
    France

    Active - Recruiting

  • Novartis Investigative Site

    Paris 10, 75475
    France

    Active - Recruiting

  • Novartis Investigative Site

    Paris Cedex 10, 75475
    France

    Site Not Available

  • Novartis Investigative Site

    Paris Cedex 19, 75935
    France

    Site Not Available

  • Novartis Investigative Site

    Pierre Benite, 69495
    France

    Active - Recruiting

  • Novartis Investigative Site

    Pierre Benite Cedex, 69495
    France

    Site Not Available

  • Novartis Investigative Site

    Regensburg, Bavaria 93053
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Frankfurt am Main, Hessen 60590
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Frankfurt, 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Koeln, 50937
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Köln, 50937
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 81377
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Ulm, 89081
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Wuerzburg, 97080
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Wurzburg, 97080
    Germany

    Site Not Available

  • Novartis Investigative Site

    Würzburg, 97080
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Monza, MB 20900
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Roma, RM 00165
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Fukuoka city, Fukuoka 812-8582
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Sapporo city, Hokkaido 060 8648
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Sapporo-city, Hokkaido 060-8648
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sakyo Ku, Kyoto 606 8507
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sakyo-ku, Kyoto 606 8507
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sendai city, Miyagi 980 8574
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Chuo ku, Tokyo 104 0045
    Japan

    Site Not Available

  • Novartis Investigative Site

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kyoto, 606 8507
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Amsterdam, 1105 AZ
    Netherlands

    Completed

  • Novartis Investigative Site

    Utrecht, 3584
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Oslo, 0310
    Norway

    Active - Recruiting

  • Novartis Investigative Site

    Singapore, 169608
    Singapore

    Active - Recruiting

  • Novartis Investigative Site

    Sevilla, Andalucia 41013
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Esplugues De Llobregat, Barcelona 08950
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Salamanca, Castilla Y Leon 37007
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Hospitalet de LLobregat, Catalunya 08907
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Valencia, Comunidad Valenciana 46010
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Madrid, 28046
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Novartis Investigative Site

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona 85054
    United States

    Completed

  • Mayo Clinic Arizona Mayo Clinic Building

    Phoenix, Arizona 85054
    United States

    Completed

  • Childrens Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Childrens Hospital Los Angeles SC CTL019

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • UCSF Medical Center

    San Francisco, California 94143
    United States

    Active - Recruiting

  • UCSF Medical Center .

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Stanford University Medical Center

    Stanford, California 94304
    United States

    Active - Recruiting

  • Stanford University Medical Center SC - CTL019B2205J - B2206

    Stanford, California 94304
    United States

    Active - Recruiting

  • Stanford Universtiy Medical Center SC - CTL019B2205J - B2206

    Stanford, California 94304
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta SC CTL019

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Childrens Healthcare of Atlanta

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Childrens Healthcare of Atlanta SC CTL019

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Emory University School of Medicine/Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • University of Chicago Medical Center, Hematology & Oncology

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Kansas Cancer Center SC

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Cente

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute Harvard Cancer Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109-2800
    United States

    Active - Recruiting

  • University of Michigan .

    Ann Arbor, Michigan 48109-2800
    United States

    Active - Recruiting

  • University of Michigan Health System SC CTL019

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of Minnesota SC-4

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Children's Mercy Hospital SC

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Site Not Available

  • Duke Unversity Medical Center SC - CTL019B2205J

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229-3039
    United States

    Active - Recruiting

  • Ohio ST Compr Cancer Ctr James Hosp

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Ohio ST Compr Cancer Ctr James Hosp Ohio State Univ.

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State Univ.

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • The Childrens Hosp of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • The Childrens Hosp of Philadelphia CHOP

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • The Childrens Hospital of Philadelphia CHOP

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • UTSW/Children's Medical Center

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • MD Anderson Cancer Center SC

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah Clinical Trials Office

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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