Recruiting

Phase 3

CAR-TCAR-T Long Term Follow Up (LTFU) Study

Sponsor:

Novartis Pharmaceuticals

Code:

NCT02445222

Conditions

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

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

Previously treated CAR-T patients

Study Details

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

Study ID

NCT02445222

Start date

Nov 2, 2015

Status verified date

Oct, 2025

Completion date

Feb 22, 2036

Anticipated

Primary completion date

Feb 22, 2036

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Previously treated CAR-T patients

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

Interventions

Previously treated CAR-T patients

Lentiviral-based CAR-T cell therapy

Primary outcome measure

Percentage of patients with certain events (see description) [ Time Frame: at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15. ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682

Novartis Pharmaceuticals

+41613241111

Locations

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010 3000

Principal Investigator:

Leslie Popplewell

Childrens Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Lee Chen

323-361-5812 lchen@chla.usc.edu

Principal Investigator:

Alan Wayne

UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

310-825-4493

Principal Investigator:

Aravind Ramakrishnan

UCSF Medical Center

Recruiting

San Francisco, California, United States, 94143

Contacts

Jenai Wilmoth

415-514-6281 jenai.wilmoth@ucsf.edu

Principal Investigator:

Charalambos Andreadis

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94304

Contacts

Christina Baggott

650-723-4000 Baggott@stanford.edu

Principal Investigator:

Kara Davis

Emory University School of Medicine-Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Sharah Triplett

Sharra.triplett@emory.edu

Principal Investigator:

Jonathon Cohen

Emory University School of Medicine/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Keshawna L. Sherer

404-778-3708 keshawna.sherer@emoryhealthcare.org

Principal Investigator:

Jonathon Cohen

Childrens Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Audry Grizzle Tumlin

+1 404 785 2125 audrey.tumlin@choa.org

Principal Investigator:

Muna Qayed

Uni of Chi Medi Ctr Hema and Onco

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Linda Schroeder

773-834-0982 lschroed@medicine.bsd.uchicago.edu

Principal Investigator:

Michael R Bishop

University of Chicago Medical Center, Hematology & Oncology

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Howie Weiner

773-834-0982 hweiner@medicine.bsd.uchicago.edu

Principal Investigator:

Michael R. Bishop

University of Kansas Cancer Center SC

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Janie Smart

913-588-6029 nsmart@kumc.edu

Principal Investigator:

Joseph P McGuirk

University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Maghen Farris

913-588-6029 mfarris@kumc.edu

Principal Investigator:

Joseph P McGuirk

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Matthew Frigault

Beth Israel Deaconess Med Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

617-667-7000

Principal Investigator:

Jacalyn Rosenblatt

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

617-632-3985

Principal Investigator:

Adam Sperling

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109-2800

Contacts

Sabrina Hargrove

sgomes@med.umich.edu

Principal Investigator:

Gregory Yanik

Uni Of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Sabrina Hargrove

734-936-8538 sgomes@med.umich.edu

Principal Investigator:

John Magenau

University of Michigan Health System SC CTL019

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Michelle Smith Tucker

734-936-8538 smimiche@umich.edu

Principal Investigator:

John Magenau

Wayne State University-Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

313-576-8716

Principal Investigator:

Abhinav Deol

Children s Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Allison Miles

816-855-1886 almiles1@cmh.edu

Principal Investigator:

Gary D. Myers

Children's Mercy Hospital SC

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Rachel Wilcox

816-302-6851 rwilcox@cmh.edu

Principal Investigator:

Gary Myers, MD

Duke Unversity Medical Center SC - CTL019B2205J

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Kristine Edwards

919-668-2967 kristine.gurganus@dm.duke.edu

Erin Arbuckle

919-684-3293 erin.arbuckle@duke.edu

Principal Investigator:

Paul L. Martin

Duke Unversity Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Nelson Chao

nelson.chao@duke.edu

Principal Investigator:

Paul L. Martin

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229-3039

Contacts

Melanie Jordan

513-636-9292 melanie.jordan@cchmc.org

Principal Investigator:

Stella M. Davies

Cinn Children Hosp Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229-3039

Contacts

Kristie Evans Stricker

+1 513 636 9292 kristie.stricker@chmc.org

Principal Investigator:

Stella M. Davies

Ohio ST Compr Cancer Ctr James Hosp

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Molly Vittorio

614-688-9494 Molly.Vittorio@osumc.edu

Principal Investigator:

David A Bond

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Beth Zentzis

503-346-1507 zentzis@ohsu.edu

Principal Investigator:

Brandon Hayes-Lattin

Oregon Health Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Mai-Lee Lee Yap

+1 503 494 6865 yap@ohsu.edu

Principal Investigator:

Brandon Hayes-Lattin

The Childrens Hosp of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Lauren Vernau

215-590-7399 VERNAUL@EMAIL.CHOP.EDU

Principal Investigator:

Stephan Grupp

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Michelle Caylor

215-898-9256 mcaylor@mail.med.upenn.edu

Principal Investigator:

Noelle Frey

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Desire Fenderson

215-615-1725 dfend@upenn.edu

Principal Investigator:

Noelle Frey

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

215-955-8699

Principal Investigator:

Usama Gergis

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Ian W Flinn

UTSW/Children's Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Alison Patterson

214-456-2726 Alison.patterson@childrens.com

Principal Investigator:

Theodore Laetsch, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Cris Molina

214-648-6449 cris.molina@childrens.com

Principal Investigator:

Samuel John

MD Anderson Cancer Center SC

Recruiting

Houston, Texas, United States, 77030

Contacts

Souzanne T. Ouzounian

713-792-2171 souzouni@mdanderson.org

Laura Hargraves

713-792-6594 lehargraves@mdanderson.org

Principal Investigator:

Jason Westin

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Souzanne T Ouzounian

713-792-2171 souzouni@mdanderson.org

Principal Investigator:

Jason Westin

University of Utah Clinical Trials Office

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Luke Stone

801-213-3395 luke.stone@hsc.utah.edu

Principal Investigator:

Michael Boyer, MD

University of Utah Clinical Trials Office

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Sydney Goosen

801-213-3401 Sydney.Goosen@hsc.utah.edu

Principal Investigator:

Michael Pulsipher

University of Wisconsin Hospital and Clinics

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Jenny Weiland

608-890-8070 PedsHemOncResearch@lists.wisc.edu

Celeste Matsushima

+1 608-890-8069 camatsus@pediatrics.wisc.edu

Principal Investigator:

Christian Capitini

University of Wisconsin Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Kreg M Grindle

kgrindle@uwhealth.org

Principal Investigator:

Christian Capitini

Novartis Investigative Site

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H3T 1C5

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2025-10-28.