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

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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.

Condition 
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
Phase 
Not Applicable
Overall status 
Recruiting
Enrollment count 
1250 participants
Start date 
Nov 02, 2015
Completion date 
Apr 28, 2035
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
Mayo Clinic Arizona Mayo Clinic Building
Completed
Phoenix, 85054
Arizona
United States
Childrens Hospital Los Angeles SC CTL019
Recruiting
Los Angeles, 90027
California
United States
UCSF Medical Center
Recruiting
San Francisco, 94143
California
United States
Stanford Universtiy Medical Center SC - CTL019B2205J - B2206
Recruiting
Stanford, 94304
California
United States
Emory University School of Medicine/Winship Cancer Institute
Recruiting
Atlanta, 30322
Georgia
United States
Children's Healthcare of Atlanta SC CTL019
Recruiting
Atlanta, 30342
Georgia
United States
University of Chicago Medical Center, Hematology & Oncology
Recruiting
Chicago, 60637
Illinois
United States
University of Kansas Cancer Center SC
Recruiting
Westwood, 66205
Kansas
United States
University of Michigan
Recruiting
Ann Arbor, 48109-2800
Michigan
United States
University of Michigan Health System SC CTL019
Recruiting
Ann Arbor, 48109
Michigan
United States
University of Minnesota SC-4
Recruiting
Minneapolis, 55455
Minnesota
United States
Children's Mercy Hospital SC
Recruiting
Kansas City, 64108
Missouri
United States
Weill Cornell Medical College
Recruiting
New York, 10065
New York
United States
Duke Unversity Medical Center SC - CTL019B2205J
Recruiting
Durham, 27705
North Carolina
United States
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati, 45229-3039
Ohio
United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State Univ.
Recruiting
Columbus, 43210
Ohio
United States
Oregon Health & Science University
Recruiting
Portland, 97239
Oregon
United States
The Childrens Hospital of Philadelphia CHOP
Recruiting
Philadelphia, 19104
Pennsylvania
United States
University of Pennsylvania
Recruiting
Philadelphia, 19104
Pennsylvania
United States
UTSW/Children's Medical Center
Recruiting
Dallas, 75235
Texas
United States
MD Anderson Cancer Center SC
Recruiting
Houston, 77030
Texas
United States
University of Utah Clinical Trials Office
Recruiting
Salt Lake City, 84108
Utah
United States
University of Wisconsin Hospital and Clinics
Recruiting
Madison, 53792
Wisconsin
United States
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3000
Victoria
Australia
Novartis Investigative Site
Recruiting
Parkville, 3052
Victoria
Australia
Novartis Investigative Site
Recruiting
Camperdown, NSW
-
Australia
Austria
Novartis Investigative Site
Recruiting
Linz, 4020
-
Austria
Novartis Investigative Site
Recruiting
Vienna, A-1090
-
Austria
Novartis Investigative Site
Recruiting
Wien, A 1090
-
Austria
Belgium
Novartis Investigative Site
Recruiting
Gent, 9000
-
Belgium
Canada
Novartis Investigative Site
Recruiting
Hamilton, L8V 1C3
Ontario
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 1X8
Ontario
Canada
Novartis Investigative Site
Recruiting
Montreal, H1T 2M4
Quebec
Canada
Novartis Investigative Site
Recruiting
Montreal, H3T 1C5
Quebec
Canada
Denmark
Novartis Investigative Site
Recruiting
Copenhagen, 2100
-
Denmark
France
Novartis Investigative Site
Recruiting
Paris Cedex 10, 75475
-
France
Novartis Investigative Site
Recruiting
Paris Cedex 19, 75935
-
France
Novartis Investigative Site
Recruiting
Paris, 75010
-
France
Novartis Investigative Site
Recruiting
Pierre Benite, 69310
-
France
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60590
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany
Italy
Novartis Investigative Site
Recruiting
Monza, 20900
MB
Italy
Japan
Novartis Investigative Site
Recruiting
Fukuoka city, 812-8582
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Sakyo Ku, 606 8507
Kyoto
Japan
Novartis Investigative Site
Recruiting
Sendai city, 980 8574
Miyagi
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104 0045
Tokyo
Japan
Netherlands
Novartis Investigative Site
Recruiting
Utrecht, 3584
CS
Netherlands
Novartis Investigative Site
Recruiting
Amsterdam, 1105 AZ
-
Netherlands
Norway
Novartis Investigative Site
Recruiting
Oslo, 0424
-
Norway
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Barcelona/ Cataluny/Espanya
Spain
Novartis Investigative Site
Recruiting
Esplugues de Llobregat, 08950
Barcelona
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Hospitalet de LLobregat, 08907
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28041
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28046
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Email: 
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]