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CAR-T Long Term Follow Up (LTFU) Study

NCT ID: NCT02445222

Last Updated: 2025-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-02

Study Completion Date

2036-02-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Previously treated CAR-T patients

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

Group Type OTHER

Previously treated CAR-T patients

Intervention Type GENETIC

Lentiviral-based CAR-T cell therapy

Interventions

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Previously treated CAR-T patients

Lentiviral-based CAR-T cell therapy

Intervention Type GENETIC

Eligibility Criteria

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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 .
Minimum Eligible Age

0 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Mayo Clinic Arizona

Phoenix, Arizona, United States

Site Status COMPLETED

City of Hope National Medical Center

Duarte, California, United States

Site Status RECRUITING

Childrens Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

UCLA Medical Center

Los Angeles, California, United States

Site Status RECRUITING

UCSF Medical Center

San Francisco, California, United States

Site Status RECRUITING

Stanford University Medical Center

Stanford, California, United States

Site Status RECRUITING

Emory University School of Medicine-Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University School of Medicine/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Childrens Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status RECRUITING

Uni of Chi Medi Ctr Hema and Onco

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago Medical Center, Hematology & Oncology

Chicago, Illinois, United States

Site Status RECRUITING

University of Kansas Cancer Center SC

Westwood, Kansas, United States

Site Status RECRUITING

University of Kansas Cancer Center

Westwood, Kansas, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Beth Israel Deaconess Med Center

Boston, Massachusetts, United States

Site Status RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Uni Of Michigan Health System

Ann Arbor, Michigan, United States

Site Status RECRUITING

University of Michigan Health System SC CTL019

Ann Arbor, Michigan, United States

Site Status RECRUITING

Wayne State University-Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

University of Minnesota

Minneapolis, Minnesota, United States

Site Status WITHDRAWN

Children s Mercy Hospital

Kansas City, Missouri, United States

Site Status RECRUITING

Children's Mercy Hospital SC

Kansas City, Missouri, United States

Site Status RECRUITING

Weill Cornell Medical College

New York, New York, United States

Site Status WITHDRAWN

Duke Unversity Medical Center SC - CTL019B2205J

Durham, North Carolina, United States

Site Status RECRUITING

Duke Unversity Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Cinn Children Hosp Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Ohio ST Compr Cancer Ctr James Hosp

Columbus, Ohio, United States

Site Status RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Oregon Health Sciences University

Portland, Oregon, United States

Site Status RECRUITING

The Childrens Hosp of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status RECRUITING

UTSW/Children's Medical Center

Dallas, Texas, United States

Site Status RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

MD Anderson Cancer Center SC

Houston, Texas, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

University of Utah Clinical Trials Office

Salt Lake City, Utah, United States

Site Status RECRUITING

University of Utah Clinical Trials Office

Salt Lake City, Utah, United States

Site Status RECRUITING

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status RECRUITING

University of Wisconsin Hospital

Madison, Wisconsin, United States

Site Status RECRUITING

Novartis Investigative Site

Camperdown, New South Wales, Australia

Site Status RECRUITING

Novartis Investigative Site

Melbourne, Victoria, Australia

Site Status RECRUITING

Novartis Investigative Site

Melbourne, Victoria, Australia

Site Status RECRUITING

Novartis Investigative Site

Parkville, Victoria, Australia

Site Status WITHDRAWN

Novartis Investigative Site

Murdoch, Western Australia, Australia

Site Status RECRUITING

Novartis Investigative Site

Herston, , Australia

Site Status RECRUITING

Novartis Investigative Site

Linz, , Austria

Site Status WITHDRAWN

Novartis Investigative Site

Salzburg, , Austria

Site Status RECRUITING

Novartis Investigative Site

Vienna, , Austria

Site Status RECRUITING

Novartis Investigative Site

Vienna, , Austria

Site Status RECRUITING

Novartis Investigative Site

Ghent, , Belgium

Site Status RECRUITING

Novartis Investigative Site

Hamilton, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status RECRUITING

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status RECRUITING

Novartis Investigative Site

Beijing, , China

Site Status RECRUITING

Novartis Investigative Site

Copenhagen, , Denmark

Site Status RECRUITING

Novartis Investigative Site

Helsinki, , Finland

Site Status RECRUITING

Novartis Investigative Site

Nantes, , France

Site Status RECRUITING

Novartis Investigative Site

Paris, , France

Site Status RECRUITING

Novartis Investigative Site

Paris, , France

Site Status RECRUITING

Novartis Investigative Site

Pierre-Bénite, , France

Site Status RECRUITING

Novartis Investigative Site

Villejuif, , France

Site Status RECRUITING

Novartis Investigative Site

Munich, Bavaria, Germany

Site Status RECRUITING

Novartis Investigative Site

Regensburg, Bavaria, Germany

Site Status RECRUITING

Novartis Investigative Site

Würzburg, Bavaria, Germany

Site Status RECRUITING

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Novartis Investigative Site

Leipzig, Saxony, Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Hamburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Ulm, , Germany

Site Status RECRUITING

Novartis Investigative Site

Chaïdári, , Greece

Site Status RECRUITING

Novartis Investigative Site

Hong Kong, , Hong Kong

Site Status RECRUITING

Novartis Investigative Site

Ramat Gan, , Israel

Site Status RECRUITING

Novartis Investigative Site

Tel Aviv, , Israel

Site Status RECRUITING

Novartis Investigative Site

Bologna, BO, Italy

Site Status RECRUITING

Novartis Investigative Site

Monza, MB, Italy

Site Status RECRUITING

Novartis Investigative Site

Milan, MI, Italy

Site Status RECRUITING

Novartis Investigative Site

Milan, MI, Italy

Site Status RECRUITING

Novartis Investigative Site

Rozzano, MI, Italy

Site Status RECRUITING

Novartis Investigative Site

Roma, RM, Italy

Site Status RECRUITING

Novartis Investigative Site

Roma, RM, Italy

Site Status RECRUITING

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Novartis Investigative Site

Sendai, Miyagi, Japan

Site Status RECRUITING

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Site Status WITHDRAWN

Novartis Investigative Site

Kyoto, , Japan

Site Status RECRUITING

Novartis Investigative Site

Amsterdam, North Holland, Netherlands

Site Status COMPLETED

Novartis Investigative Site

Utrecht, , Netherlands

Site Status COMPLETED

Novartis Investigative Site

Utrecht, , Netherlands

Site Status WITHDRAWN

Novartis Investigative Site

Oslo, , Norway

Site Status RECRUITING

Novartis Investigative Site

Oslo, , Norway

Site Status RECRUITING

Novartis Investigative Site

Riyadh, , Saudi Arabia

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Esplugues, Barcelona, Spain

Site Status RECRUITING

Novartis Investigative Site

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Novartis Investigative Site

Salamanca, Castille and León, Spain

Site Status RECRUITING

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status RECRUITING

Novartis Investigative Site

Pamplona, Navarre, Spain

Site Status RECRUITING

Novartis Investigative Site

Barcelona, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Seville, , Spain

Site Status RECRUITING

Novartis Investigative Site

Valencia, , Spain

Site Status RECRUITING

Novartis Investigative Site

Taipei, , Taiwan

Site Status RECRUITING

Novartis Investigative Site

Birmingham, , United Kingdom

Site Status RECRUITING

Novartis Investigative Site

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Austria Belgium Canada China Denmark Finland France Germany Greece Hong Kong Israel Italy Japan Netherlands Norway Saudi Arabia Singapore South Korea Spain Taiwan United Kingdom

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

1-888-669-6682

Novartis Pharmaceuticals

Role: CONTACT

+41613241111

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lee Chen

Role: primary

[email protected]
323-361-5812

Role: primary

310-825-4493

Jenai Wilmoth

Role: primary

[email protected]
415-514-6281

Christina Baggott

Role: primary

[email protected]
650-723-4000

Sharah Triplett

Role: primary

[email protected]

Keshawna L. Sherer

Role: primary

[email protected]
404-778-3708

Audry Grizzle Tumlin

Role: primary

[email protected]
+1 404 785 2125

Linda Schroeder

Role: primary

[email protected]
773-834-0982

Howie Weiner

Role: primary

[email protected]
773-834-0982

Janie Smart

Role: primary

[email protected]
913-588-6029

Maghen Farris

Role: primary

[email protected]
913-588-6029

Role: primary

617-667-7000

Role: primary

617-632-3985

Sabrina Hargrove

Role: primary

[email protected]

Sabrina Hargrove

Role: primary

[email protected]
734-936-8538

Michelle Smith Tucker

Role: primary

[email protected]
734-936-8538

Role: primary

313-576-8716

Allison Miles

Role: primary

[email protected]
816-855-1886

Rachel Wilcox

Role: primary

[email protected]
816-302-6851

Kristine Edwards

Role: primary

[email protected]
919-668-2967

Erin Arbuckle

Role: backup

[email protected]
919-684-3293

Nelson Chao

Role: primary

[email protected]

Melanie Jordan

Role: primary

[email protected]
513-636-9292

Kristie Evans Stricker

Role: primary

[email protected]
+1 513 636 9292

Molly Vittorio

Role: primary

[email protected]
614-688-9494

Beth Zentzis

Role: primary

[email protected]
503-346-1507

Mai-Lee Lee Yap

Role: primary

[email protected]
+1 503 494 6865

Lauren Vernau

Role: primary

[email protected]
215-590-7399

Michelle Caylor

Role: primary

[email protected]
215-898-9256

Desire Fenderson

Role: primary

[email protected]
215-615-1725

Role: primary

215-955-8699

Alison Patterson

Role: primary

[email protected]
214-456-2726

Cris Molina

Role: primary

[email protected]
214-648-6449

Souzanne T. Ouzounian

Role: primary

[email protected]
713-792-2171

Laura Hargraves

Role: backup

[email protected]
713-792-6594

Souzanne T Ouzounian

Role: primary

[email protected]
713-792-2171

Luke Stone

Role: primary

[email protected]
801-213-3395

Sydney Goosen

Role: primary

[email protected]
801-213-3401

Jenny Weiland

Role: primary

[email protected]
608-890-8070

Celeste Matsushima

Role: backup

[email protected]
+1 608-890-8069

Kreg M Grindle

Role: primary

[email protected]

Other Identifiers

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2014-001673-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CCTL019A2205B

Identifier Type: -

Identifier Source: org_study_id

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