Last Update: Mar 05, 2024
Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
ClinicalTrials.gov Identifier:
NCT02445222
Novartis Reference Number:CCTL019A2205B
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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. 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.

Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Phase3
Recruiting
1400
Nov 02, 2015
Feb 22, 2036
All
- (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 Location

Novartis Investigative Site

Recruiting

Melbourne,Victoria,3000,Australia

Novartis Investigative Site

Recruiting

Camperdown,Nsw,Australia

Novartis Investigative Site

Recruiting

Parkville,Victoria,3052,Australia

Novartis Investigative Site

Recruiting

Wien,A 1090,Austria

Novartis Investigative Site

Recruiting

Gent,9000,Belgium

Novartis Investigative Site

Recruiting

Hamilton,Ontario,L8v 1c3,Canada

Novartis Investigative Site

Recruiting

Montreal,Quebec,H1t 2m4,Canada

Novartis Investigative Site

Recruiting

Toronto,Ontario,M5g 1x8,Canada

Novartis Investigative Site

Recruiting

Montreal,Quebec,H3t 1c5,Canada

Novartis Investigative Site

Recruiting

Copenhagen,2100,Denmark

Novartis Investigative Site

Recruiting

Helsinki,00029,Finland

Novartis Investigative Site

Recruiting

Pierre Benite,69495,France

Novartis Investigative Site

Recruiting

Paris 10,75475,France

Novartis Investigative Site

Recruiting

Paris,75019,France

Novartis Investigative Site

Recruiting

Ulm,89081,Germany

Novartis Investigative Site

Recruiting

Muenchen,81377,Germany

Novartis Investigative Site

Recruiting

Frankfurt,60590,Germany

Novartis Investigative Site

Recruiting

Regensburg,Bavaria,93053,Germany

Novartis Investigative Site

Recruiting

Koeln,50937,Germany

Novartis Investigative Site

Recruiting

Berlin,13353,Germany

Novartis Investigative Site

Recruiting

Wuerzburg,97080,Germany

Novartis Investigative Site

Recruiting

Leipzig,04103,Germany

Novartis Investigative Site

Recruiting

Hamburg,20246,Germany

Novartis Investigative Site

Recruiting

Ramat Gan,52621,Israel

Novartis Investigative Site

Recruiting

Tel Aviv,6423906,Israel

Novartis Investigative Site

Recruiting

Monza,MB,20900,Italy

Novartis Investigative Site

Recruiting

Roma,RM,00165,Italy

Novartis Investigative Site

Recruiting

Sendai city,Miyagi,980 8574,Japan

Novartis Investigative Site

Recruiting

Fukuoka city,Fukuoka,812-8582,Japan

Novartis Investigative Site

Recruiting

Kyoto,606 8507,Japan

Novartis Investigative Site

Recruiting

Chuo ku,Tokyo,104 0045,Japan

Novartis Investigative Site

Recruiting

Sapporo city,Hokkaido,060 8648,Japan

Novartis Investigative Site

Recruiting

Oslo,0424,Norway

Novartis Investigative Site

Recruiting

Oslo,No 0424,Norway

Novartis Investigative Site

Recruiting

Singapore,169608,Singapore

Novartis Investigative Site

Recruiting

Madrid,28009,Spain

Novartis Investigative Site

Recruiting

Valencia,Comunidad Valenciana,46010,Spain

Novartis Investigative Site

Recruiting

Sevilla,Andalucia,41013,Spain

Novartis Investigative Site

Recruiting

Esplugues De Llobregat,Barcelona,08950,Spain

Novartis Investigative Site

Recruiting

Madrid,28041,Spain

Novartis Investigative Site

Recruiting

Barcelona,Catalunya,08035,Spain

Novartis Investigative Site

Recruiting

Hospitalet de LLobregat,Catalunya,08907,Spain

Novartis Investigative Site

Recruiting

Madrid,28046,Spain

Novartis Investigative Site

Recruiting

Barcelona,08041,Spain

Novartis Investigative Site

Recruiting

Salamanca,Castilla Y Leon,37007,Spain

Novartis Investigative Site

Recruiting

Taipei,10002,Taiwan

Novartis Investigative Site

Recruiting

London,Se5 9rs,United Kingdom

University of Michigan Health System SC CTL019

Recruiting

Ann Arbor,Michigan,48109,United States

Stanford Universtiy Medical Center SC - CTL019B2205J - B2206

Recruiting

Stanford,California,94304,United States

MD Anderson Cancer Center SC

Recruiting

Houston,Texas,77030,United States

Children's Healthcare of Atlanta SC CTL019

Recruiting

Atlanta,Georgia,30342,United States

University of Minnesota SC-4

Recruiting

Minneapolis,Minnesota,55455,United States

University of Pennsylvania

Recruiting

Philadelphia,Pennsylvania,19104,United States

Children's Mercy Hospital SC

Recruiting

Kansas City,Missouri,64108,United States

UCSF Medical Center .

Recruiting

San Francisco,California,94143,United States

Childrens Hospital Los Angeles SC CTL019

Recruiting

Los Angeles,California,90027,United States

University of Utah Clinical Trials Office

Recruiting

Salt Lake City,Utah,84108,United States

University of Chicago Medical Center, Hematology & Oncology

Recruiting

Chicago,Illinois,60637,United States

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati,Ohio,45229-3039,United States

University of Wisconsin Hospital and Clinics

Recruiting

Madison,Wisconsin,53792,United States

University of Kansas Cancer Center SC

Recruiting

Westwood,Kansas,66205,United States

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

Recruiting

Columbus,Ohio,43210,United States

Duke Unversity Medical Center SC - CTL019B2205J

Recruiting

Durham,North Carolina,27705,United States

UTSW/Children's Medical Center

Recruiting

Dallas,Texas,75235,United States

University of Michigan .

Recruiting

Ann Arbor,Michigan,48109-2800,United States

Oregon Health & Science University

Recruiting

Portland,Oregon,97239,United States

Emory University School of Medicine/Winship Cancer Institute

Recruiting

Atlanta,Georgia,30322,United States

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

+41613241111

Novartis Pharmaceuticals

1-888-669-6682