CAR-T Long Term Follow Up (LTFU) Study

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

ClinicalTrials.gov Identifier: NCT02445222

Novartis Reference Number: CCTL019A2205B

Last Update: Mar 10, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

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

Phase

Not Applicable

Overall status

Recruiting

Start date

Nov 02, 2015

Completion date

Feb 22, 2036

Gender

All

Age(s)

(Child, Adult, Older Adult)

Interventions

Genetic

Previously treated CAR-T patients

Lentiviral-based CAR-T cell therapy

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.

Study Locations

United States

Childrens Hospital Los Angeles SC CTL019

Recruiting

Los Angeles, 90027 - California

Contact: Lee Chen (323-361-8670) - [email protected] - Alan Wayne

United States

UCSF Medical Center

Recruiting

San Francisco, 94143 - California

Contact: Jenai A. Wilmoth (415-514-6281) - [email protected] - Charalambos Andreadis

United States

Stanford Universtiy Medical Center SC - CTL019B2205J - B2206

Recruiting

Stanford, 94304 - California

Contact: Michael Kunicki (650-725-1662) - [email protected] - Kara Davis

United States

Emory University School of Medicine/Winship Cancer Institute

Recruiting

Atlanta, 30322 - Georgia

Contact: Keshawna L. Sherer (404-778-3708) - [email protected] - Jonathon Cohen

United States

Children's Healthcare of Atlanta SC CTL019

Recruiting

Atlanta, 30342 - Georgia

Contact: Megan Grizzle Hanby (+1 404 785 2125) - [email protected] - Muna Qayed

United States

University of Chicago Medical Center, Hematology & Oncology

Recruiting

Chicago, 60637 - Illinois

Contact: Howie Weiner (773-834-0982) - [email protected] - Michael R. Bishop

United States

University of Kansas Cancer Center SC

Recruiting

Westwood, 66205 - Kansas

Contact: Janie Smart (913-588-6029) - [email protected] - Joseph P McGuirk

United States

University of Michigan

Recruiting

Ann Arbor, 48109-2800 - Michigan

Contact: Sheryl Morgan - [email protected] - Gregory Yanik

United States

University of Michigan Health System SC CTL019

Recruiting

Ann Arbor, 48109 - Michigan

Contact: Michelle Smith Tucker (734-936-8538) - [email protected] - John Magenau

United States

University of Minnesota SC-4

Recruiting

Minneapolis, 55455 - Minnesota

Contact: Danielle Jin (612-625-1610) - [email protected] - Veronika Bachanova

United States

Children's Mercy Hospital SC

Recruiting

Kansas City, 64108 - Missouri

Contact: Rachel Wilcox (816-302-6851) - [email protected] - Gary Myers, MD Gary D. Myers

United States

Duke Unversity Medical Center SC - CTL019B2205J

Recruiting

Durham, 27705 - North Carolina

Contact: Kristine Edwards (919-668-2967) - [email protected] - Erin Arbuckle (919-684-3293) - [email protected] - Paul L. Martin

United States

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, 45229-3039 - Ohio

Contact: Melanie Jordan (513-636-9292) - [email protected] - Stella M. Davies

United States

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

Recruiting

Columbus, 43210 - Ohio

Contact: Poesha Smith (614-688-9494) - [email protected] - Samantha Jaglowski

United States

Oregon Health & Science University

Recruiting

Portland, 97239 - Oregon

Contact: Beth Zentzis (503-346-1507) - [email protected] - Brandon Hayes-Lattin

United States

The Childrens Hospital of Philadelphia CHOP

Recruiting

Philadelphia, 19104 - Pennsylvania

Contact: Brendan S. Molander (267-425-5837) - [email protected] - Stephan Grupp

United States

University of Pennsylvania

Recruiting

Philadelphia, 19104 - Pennsylvania

Contact: Michelle Caylor (215-898-9256) - [email protected] - Noelle Frey

United States

UTSW/Children's Medical Center

Recruiting

Dallas, 75235 - Texas

Contact: Alison Patterson (214-456-2726) - [email protected] - Theodore Laetsch, MD Theodore Laetsch

United States

MD Anderson Cancer Center SC

Recruiting

Houston, 77030 - Texas

Contact: Souzanne T. Ouzounian (713-792-2171) - [email protected] - Laura Hargraves (713-792-6594) - [email protected] - Jason Westin

United States

University of Utah Clinical Trials Office

Recruiting

Salt Lake City, 84108 - Utah

Contact: Luke Stone (801-213-3395) - [email protected] - Michael Boyer, MD Michael Boyer

United States

University of Wisconsin Hospital and Clinics

Recruiting

Madison, 53792 - Wisconsin

Contact: Jenny Weiland (608-890-8070) - [email protected] - Celeste Matsushima (+1 608-890-8069) - [email protected] - Christian Capitini

United States

Australia