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.
Interventions
Previously treated CAR-T patients
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
Parkville,Victoria,3052,Australia
Novartis Investigative Site
Recruiting
Melbourne,Victoria,3000,Australia
Novartis Investigative Site
Recruiting
Camperdown,Nsw,Australia
Novartis Investigative Site
Recruiting
Wien,1090,Austria
Novartis Investigative Site
Recruiting
Wien,A 1090,Austria
Novartis Investigative Site
Recruiting
Gent,9000,Belgium
Novartis Investigative Site
Recruiting
Montreal,Quebec,H3t 1c5,Canada
Novartis Investigative Site
Recruiting
Hamilton,Ontario,L8v 1c3,Canada
Novartis Investigative Site
Recruiting
Toronto,Ontario,M5g 1x8,Canada
Novartis Investigative Site
Recruiting
Montreal,Quebec,H1t 2m4,Canada
Novartis Investigative Site
Recruiting
Copenhagen,Dk-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
Regensburg,Bavaria,93053,Germany
Novartis Investigative Site
Recruiting
Muenchen,81377,Germany
Novartis Investigative Site
Recruiting
Wuerzburg,97080,Germany
Novartis Investigative Site
Recruiting
Frankfurt,60590,Germany
Novartis Investigative Site
Recruiting
Koeln,50937,Germany
Novartis Investigative Site
Recruiting
Ulm,89081,Germany
Novartis Investigative Site
Recruiting
Berlin,13353,Germany
Novartis Investigative Site
Recruiting
Leipzig,04103,Germany
Novartis Investigative Site
Recruiting
Hamburg,20246,Germany
Novartis Investigative Site
Recruiting
Tel Aviv,6423906,Israel
Novartis Investigative Site
Recruiting
Ramat Gan,52621,Israel
Novartis Investigative Site
Recruiting
Monza,MB,20900,Italy
Novartis Investigative Site
Recruiting
Roma,RM,00165,Italy
Novartis Investigative Site
Recruiting
Chuo ku,Tokyo,104 0045,Japan
Novartis Investigative Site
Recruiting
Sapporo city,Hokkaido,060 8648,Japan
Novartis Investigative Site
Recruiting
Fukuoka city,Fukuoka,812-8582,Japan
Novartis Investigative Site
Recruiting
Sendai city,Miyagi,980 8574,Japan
Novartis Investigative Site
Recruiting
Kyoto,606 8507,Japan
Novartis Investigative Site
Recruiting
Utrecht,3584cx,Netherlands
Novartis Investigative Site
Recruiting
Oslo,0310,Norway
Novartis Investigative Site
Recruiting
Oslo,0424,Norway
Novartis Investigative Site
Recruiting
Singapore,169608,Singapore
Novartis Investigative Site
Recruiting
Madrid,28009,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
Salamanca,Castilla Y Leon,37007,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
Sevilla,Andalucia,41013,Spain
Novartis Investigative Site
Recruiting
Valencia,Comunidad Valenciana,46010,Spain
Novartis Investigative Site
Recruiting
Taipei,10002,Taiwan
Novartis Investigative Site
Recruiting
London,Se5 9rs,United Kingdom
The Childrens Hosp of Philadelphia CHOP
Recruiting
Philadelphia,Pennsylvania,19104,United States
Stephan Grupp
Noelle Frey
Beth Israel Deaconess Medical Cente
Recruiting
Boston,Massachusetts,02215,United States
Jessica Liegel
Adam Sperling
Childrens Hospital Los Angeles SC CTL019
Recruiting
Los Angeles,California,90027,United States
Alan Wayne
Oregon Health & Science University
Recruiting
Portland,Oregon,97239,United States
Brandon Hayes-Lattin
University of Michigan .
Recruiting
Ann Arbor,Michigan,48109-2800,United States
Connie Varner
Gregory Yanik
MD Anderson Cancer Center SC
Recruiting
Houston,Texas,77030,United States
Jason Westin
Children's Mercy Hospital SC
Recruiting
Kansas City,Missouri,64108,United States
Gary D. Myers
Gary Myers, MD
University of Wisconsin Hospital and Clinics
Recruiting
Madison,Wisconsin,53792,United States
Christian Capitini
Duke Unversity Medical Center SC - CTL019B2205J
Recruiting
Durham,North Carolina,27705,United States
Paul L. Martin
UCSF Medical Center .
Recruiting
San Francisco,California,94143,United States
Charalambos Andreadis
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati,Ohio,45229-3039,United States
Stella M. Davies
Stanford University Medical Center SC - CTL019B2205J - B2206
Recruiting
Stanford,California,94304,United States
Kara Davis
University of Michigan Health System SC CTL019
Recruiting
Ann Arbor,Michigan,48109,United States
John Magenau
University of Chicago Medical Center, Hematology & Oncology
Recruiting
Chicago,Illinois,60637,United States
Michael R. Bishop
Ohio ST Compr Cancer Ctr James Hosp Ohio State Univ.
Recruiting
Columbus,Ohio,43210,United States
Samantha Jaglowski
Childrens Healthcare of Atlanta SC CTL019
Recruiting
Atlanta,Georgia,30342,United States
Muna Qayed
UTSW/Children's Medical Center
Recruiting
Dallas,Texas,75235,United States
Theodore Laetsch, MD
Theodore Laetsch
Emory University School of Medicine/Winship Cancer Institute
Recruiting
Atlanta,Georgia,30322,United States
Jonathon Cohen
University of Utah Clinical Trials Office
Recruiting
Salt Lake City,Utah,84108,United States
Michael Boyer, MD
Michael Boyer
University of Minnesota SC-4
Recruiting
Minneapolis,Minnesota,55455,United States
Veronika Bachanova
University of Kansas Cancer Center SC
Recruiting
Westwood,Kansas,66205,United States
Joseph P McGuirk
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.