CAR-T Long Term Follow Up (LTFU) Study

NCT02445222 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: CCTL019A2205B2014-001673-142014
• Study Type: interventional
• Target: 1,105
• Locations: 22 countries
• Sites: 117

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with certain events (see description)

  The percentage of pts with listed categories: New secondary malignancies, new serious infection, new incidence of serious neurologic disorder, New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, New incidence of a hematologic disorder

  at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15.

Secondary Outcomes (5)

• Percentage of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre- specified time points

  at M3 post treatment, M6, M9, M12 and every 6M up to year 5, yearly until year 15.

• Percentage of patients with detectable RCL by VSV-G

  at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15

• Percentage of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death

  at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15.

• B- and T- lymphocyte count

  at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15.

• Height and weight, Tanner staging, menstruation status

  at M3 post treatment then M6, M12 and every year until year 15.

Study Arms (1)

Previously treated CAR-T patients

OTHER

Patients who previously were exposed to lentiviral-based CART cell therapy

Genetic: Previously treated CAR-T patients

Interventions

Previously treated CAR-T patients GENETIC

Lentiviral-based CAR-T cell therapy

Previously treated CAR-T patients

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• University of Pennsylvania: collaborator

Study Sites (120)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

COMPLETED

City of Hope National Medical Center

Duarte, California, 91010-3000, United States

RECRUITING

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

UCSF Medical Center

San Francisco, California, 94143, United States

RECRUITING

Stanford University Medical Center

Stanford, California, 94304, United States

RECRUITING

Emory University School of Medicine-Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory University School of Medicine/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Childrens Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

RECRUITING

Uni of Chi Medi Ctr Hema and Onco

Chicago, Illinois, 60637, United States

RECRUITING

University of Chicago Medical Center, Hematology & Oncology

Chicago, Illinois, 60637, United States

RECRUITING

University of Kansas Cancer Center SC

Westwood, Kansas, 66205, United States

RECRUITING

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beth Israel Deaconess Med Center

Boston, Massachusetts, 02215, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109-2800, United States

RECRUITING

Uni Of Michigan Health System

Ann Arbor, Michigan, 48109, United States

RECRUITING

University of Michigan Health System SC CTL019

Ann Arbor, Michigan, 48109, United States

RECRUITING

Wayne State University-Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

WITHDRAWN

Children s Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

Children's Mercy Hospital SC

Kansas City, Missouri, 64108, United States

RECRUITING

Weill Cornell Medical College

New York, New York, 10065, United States

WITHDRAWN

Duke Unversity Medical Center SC - CTL019B2205J

Durham, North Carolina, 27705, United States

RECRUITING

Duke Unversity Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

RECRUITING

Cinn Children Hosp Medical Center

Cincinnati, Ohio, 45229-3039, United States

RECRUITING

Ohio ST Compr Cancer Ctr James Hosp

Columbus, Ohio, 43210, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Oregon Health Sciences University

Portland, Oregon, 97239, United States

RECRUITING

The Childrens Hosp of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

UTSW/Children's Medical Center

Dallas, Texas, 75235, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MD Anderson Cancer Center SC

Houston, Texas, 77030, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Utah Clinical Trials Office

Salt Lake City, Utah, 84108, United States

RECRUITING

University of Utah Clinical Trials Office

Salt Lake City, Utah, 84108, United States

RECRUITING

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

RECRUITING

University of Wisconsin Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

Novartis Investigative Site

Camperdown, New South Wales, 2050, Australia

RECRUITING

Novartis Investigative Site

Melbourne, Victoria, 3000, Australia

RECRUITING

Novartis Investigative Site

Melbourne, Victoria, 3004, Australia

RECRUITING

Novartis Investigative Site

Parkville, Victoria, 3052, Australia

WITHDRAWN

Novartis Investigative Site

Murdoch, Western Australia, 6150, Australia

RECRUITING

Novartis Investigative Site

Herston, 4006, Australia

RECRUITING

Novartis Investigative Site

Linz, 4020, Austria

WITHDRAWN

Novartis Investigative Site

Salzburg, 5020, Austria

RECRUITING

Novartis Investigative Site

Vienna, 1090, Austria

RECRUITING

Novartis Investigative Site

Ghent, 9000, Belgium

RECRUITING

Novartis Investigative Site

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

Novartis Investigative Site

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Novartis Investigative Site

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Novartis Investigative Site

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Novartis Investigative Site

Beijing, 100036, China

RECRUITING

Novartis Investigative Site

Copenhagen, 2100, Denmark

RECRUITING

Novartis Investigative Site

Helsinki, 00029, Finland

RECRUITING

Novartis Investigative Site

Nantes, 44093, France

RECRUITING

Novartis Investigative Site

Paris, 75013, France

RECRUITING

Novartis Investigative Site

Paris, 75019, France

RECRUITING

Novartis Investigative Site

Paris, 75475, France

RECRUITING

Novartis Investigative Site

Pessac, 33604, France

RECRUITING

Novartis Investigative Site

Pierre-Bénite, 69495, France

RECRUITING

Novartis Investigative Site

Strasbourg, 67091, France

RECRUITING

Novartis Investigative Site

Villejuif, 94800, France

RECRUITING

Novartis Investigative Site

Munich, Bavaria, 81377, Germany

RECRUITING

Novartis Investigative Site

Regensburg, Bavaria, 93053, Germany

RECRUITING

Novartis Investigative Site

Würzburg, Bavaria, 97080, Germany

RECRUITING

Novartis Investigative Site

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Novartis Investigative Site

Leipzig, Saxony, 04103, Germany

RECRUITING

Novartis Investigative Site

Berlin, 13353, Germany

RECRUITING

Novartis Investigative Site

Hamburg, 20246, Germany

RECRUITING

Novartis Investigative Site

Ulm, 89081, Germany

RECRUITING

Novartis Investigative Site

Chaïdári, 124 62, Greece

RECRUITING

Novartis Investigative Site

Hong Kong, 999077, Hong Kong

RECRUITING

Novartis Investigative Site

Ramat Gan, 5265601, Israel

RECRUITING

Novartis Investigative Site

Tel Aviv, 6423906, Israel

RECRUITING

Novartis Investigative Site

Bologna, BO, 40138, Italy

RECRUITING

Novartis Investigative Site

Monza, MB, 20900, Italy

RECRUITING

Novartis Investigative Site

Milan, MI, 20132, Italy

RECRUITING

Novartis Investigative Site

Milan, MI, 20133, Italy

RECRUITING

Novartis Investigative Site

Rozzano, MI, 20089, Italy

RECRUITING

Novartis Investigative Site

Roma, RM, 00165, Italy

RECRUITING

Novartis Investigative Site

Roma, RM, 00168, Italy

RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, 0608648, Japan

RECRUITING

Novartis Investigative Site

Sendai, Miyagi, 9808574, Japan

RECRUITING

Novartis Investigative Site

Chuo Ku, Tokyo, 1040045, Japan

WITHDRAWN

Novartis Investigative Site

Fukuoka, 8128582, Japan

RECRUITING

Novartis Investigative Site

Kyoto, 6068507, Japan

RECRUITING

Novartis Investigative Site

Amsterdam, North Holland, 1105 AZ, Netherlands

COMPLETED

Novartis Investigative Site

Utrecht, 3584 CS, Netherlands

COMPLETED

Novartis Investigative Site

Utrecht, 3584 CX, Netherlands

WITHDRAWN

Novartis Investigative Site

Oslo, 0310, Norway

RECRUITING

Novartis Investigative Site

Oslo, 0424, Norway

RECRUITING

Novartis Investigative Site

Riyadh, 11211, Saudi Arabia

RECRUITING

Novartis Investigative Site

Singapore, 119074, Singapore

RECRUITING

Novartis Investigative Site

Singapore, 169608, Singapore

RECRUITING

Novartis Investigative Site

Seoul, 03080, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 03722, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 05505, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 06351, South Korea

RECRUITING

Novartis Investigative Site

Esplugues, Barcelona, 08950, Spain

RECRUITING

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

RECRUITING

Novartis Investigative Site

Barcelona, 08035, Spain

RECRUITING

Novartis Investigative Site

Barcelona, 08041, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28009, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28041, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28046, Spain

RECRUITING

Novartis Investigative Site

Salamanca, 37007, Spain

RECRUITING

Novartis Investigative Site

Seville, 41013, Spain

RECRUITING

Novartis Investigative Site

Valencia, 46010, Spain

RECRUITING

Novartis Investigative Site

Taipei, 10002, Taiwan

RECRUITING

Novartis Investigative Site

Birmingham, West Midlands, B15 2TH, United Kingdom

RECRUITING

Novartis Investigative Site

London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (1)

• Maziarz RT, Bishop MR, Tam CS, Borchmann P, Worel N, McGuirk JP, Holte H, Waller EK, Jaglowski S, Andreadis C, Foley SR, Westin JR, Fleury I, Ho PJ, Mielke S, Teshima T, Janakiram M, Hsu J, Izutsu K, Kersten MJ, Ghosh M, Wagner-Johnston N, Kato K, Corradini P, Ma W, Han X, Nuortti M, Awasthi R, Mundt KE, Majdan M, Maier HJ, Jegerlehner A, Salles G, Schuster SJ. Five-Year Analysis of the JULIET Trial of Tisagenlecleucel in Patients With Relapsed/Refractory Large B-Cell Lymphoma. J Clin Oncol. 2026 Jan 10;44(2):86-91. doi: 10.1200/JCO-25-00507. Epub 2025 Nov 18.

  PMID: 41252666 DERIVED

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 15, 2015
• Study Start: November 2, 2015
• Primary Completion (Estimated): April 18, 2039
• Study Completion (Estimated): April 18, 2039
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

GB (2); GR (1); CN (1); FI (1); BE (1); FR (8); SG (2); CA (4); NL (3); SA (1); ES (11); DE (9); NO (2); US (44); IL (2); AU (6); IT (7); TW (1); DK (1); HK (1); JP (5); KR (4)