Home › NCT02445222

CAR-T Long Term Follow Up (LTFU) Study

RecruitingPhase 3

Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy

Who can join

Ages 0 to 100 · All sexes

Full 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.

About the study

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.

What is being tested

Previously treated CAR-T patients (genetic)

Sponsor: Novartis Pharmaceuticals · Participants: 1,400 · Started: Nov 2, 2015

Contact the study team

Novartis Pharmaceuticals · Phone: 1-888-669-6682
Novartis Pharmaceuticals · Phone: +41613241111

Official record on ClinicalTrials.gov — NCT02445222

Locations in the U.S.

California	City of Hope National Medical Center, Duarte Childrens Hospital Los Angeles, Los Angeles UCLA Medical Center, Los Angeles UCSF Medical Center, San Francisco Stanford University Medical Center, Stanford
Georgia	Childrens Healthcare of Atlanta, Atlanta Emory University School of Medicine-Winship Cancer Institute, Atlanta Emory University School of Medicine/Winship Cancer Institute, Atlanta
Illinois	Uni of Chi Medi Ctr Hema and Onco, Chicago University of Chicago Medical Center, Hematology & Oncology, Chicago
Kansas	University of Kansas Cancer Center, Westwood University of Kansas Cancer Center SC, Westwood
Massachusetts	Beth Israel Deaconess Med Center, Boston Dana Farber Cancer Institute, Boston Massachusetts General Hospital, Boston
Michigan	Uni Of Michigan Health System, Ann Arbor University of Michigan, Ann Arbor University of Michigan Health System SC CTL019, Ann Arbor Wayne State University-Karmanos Cancer Institute, Detroit
Missouri	Children s Mercy Hospital, Kansas City Children's Mercy Hospital SC, Kansas City
North Carolina	Duke Unversity Medical Center, Durham Duke Unversity Medical Center SC - CTL019B2205J, Durham
Ohio	Cincinnati Children's Hospital Medical Center, Cincinnati Cinn Children Hosp Medical Center, Cincinnati Ohio ST Compr Cancer Ctr James Hosp, Columbus
Oregon	Oregon Health & Science University, Portland Oregon Health Sciences University, Portland
Pennsylvania	The Childrens Hosp of Philadelphia, Philadelphia Thomas Jefferson University, Philadelphia University of Pennsylvania, Philadelphia University of Pennsylvania, Philadelphia
Tennessee	Sarah Cannon Research Institute, Nashville
Texas	UTSW/Children's Medical Center, Dallas University of Texas Southwestern Medical Center, Dallas MD Anderson Cancer Center, Houston MD Anderson Cancer Center SC, Houston
Utah	University of Utah Clinical Trials Office, Salt Lake City University of Utah Clinical Trials Office, Salt Lake City
Wisconsin	University of Wisconsin Hospital, Madison University of Wisconsin Hospital and Clinics, Madison

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.