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.
Novartis Investigative Site
Recruiting
Melbourne,Victoria,3000,Australia
Novartis Investigative Site
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Camperdown,Nsw,Australia
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Wien,1090,Austria
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Wien,A 1090,Austria
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Gent,9000,Belgium
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Montreal,Quebec,H3t 1c5,Canada
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Hamilton,Ontario,L8v 1c3,Canada
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Toronto,Ontario,M5g 1x8,Canada
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Montreal,Quebec,H1t 2m4,Canada
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Copenhagen,Dk-2100,Denmark
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Helsinki,00029,Finland
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Paris 10,75475,France
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Paris,75019,France
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Pierre Benite,69495,France
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Muenchen,81377,Germany
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Berlin,13353,Germany
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Ulm,89081,Germany
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Frankfurt,60590,Germany
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Wuerzburg,97080,Germany
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Hamburg,20246,Germany
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Koeln,50937,Germany
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Leipzig,04103,Germany
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Regensburg,Bavaria,93053,Germany
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Ramat Gan,52621,Israel
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Tel Aviv,6423906,Israel
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Monza,MB,20900,Italy
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Roma,RM,00165,Italy
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Fukuoka city,Fukuoka,812-8582,Japan
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Sapporo city,Hokkaido,060 8648,Japan
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Sendai city,Miyagi,980 8574,Japan
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Kyoto,606 8507,Japan
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Oslo,0310,Norway
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Oslo,0424,Norway
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Singapore,169608,Singapore
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Valencia,Comunidad Valenciana,46010,Spain
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Barcelona,08041,Spain
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Sevilla,Andalucia,41013,Spain
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Madrid,28009,Spain
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Esplugues De Llobregat,Barcelona,08950,Spain
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Madrid,28041,Spain
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Salamanca,Castilla Y Leon,37007,Spain
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Madrid,28046,Spain
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Barcelona,Catalunya,08035,Spain
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Hospitalet de LLobregat,Catalunya,08907,Spain
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Taipei,10002,Taiwan
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London,Se5 9rs,United Kingdom
Children's Mercy Hospital SC
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Kansas City,Missouri,64108,United States
Gary D. Myers
Gary Myers, MD
Childrens Healthcare of Atlanta
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Atlanta,Georgia,30342,United States
Muna Qayed
UTSW/Children's Medical Center
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Dallas,Texas,75235,United States
Theodore Laetsch, MD
Theodore Laetsch
The Childrens Hosp of Philadelphia
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Philadelphia,Pennsylvania,19104,United States
Stephan Grupp
Noelle Frey
Beth Israel Deaconess Medical Cente
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Boston,Massachusetts,02215,United States
Adam Sperling
Jessica Liegel
Childrens Hospital Los Angeles
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Los Angeles,California,90027,United States
Alan Wayne
Oregon Health & Science University
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Portland,Oregon,97239,United States
Brandon Hayes-Lattin
University of Chicago Medical Center, Hematology & Oncology
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Chicago,Illinois,60637,United States
Michael R. Bishop
University of Michigan
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Ann Arbor,Michigan,48109-2800,United States
Sabrina Hargrove
Gregory Yanik
University of Utah Clinical Trials Office
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Salt Lake City,Utah,84108,United States
Michael Boyer
Michael Boyer, MD
Duke Unversity Medical Center SC - CTL019B2205J
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Durham,North Carolina,27705,United States
Paul L. Martin
Ohio ST Compr Cancer Ctr James Hosp
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Columbus,Ohio,43210,United States
Samantha Jaglowski
University of Wisconsin Hospital and Clinics
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Madison,Wisconsin,53792,United States
Christian Capitini
MD Anderson Cancer Center SC
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Houston,Texas,77030,United States
Jason Westin
University of Michigan Health System SC CTL019
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Ann Arbor,Michigan,48109,United States
John Magenau
UCSF Medical Center
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San Francisco,California,94143,United States
Charalambos Andreadis
University of Kansas Cancer Center SC
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Westwood,Kansas,66205,United States
Joseph P McGuirk
Cincinnati Children's Hospital Medical Center
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Cincinnati,Ohio,45229-3039,United States
Stella M. Davies
Stanford University Medical Center
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Stanford,California,94304,United States
Kara Davis
Emory University School of Medicine/Winship Cancer Institute
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Atlanta,Georgia,30322,United States
Jonathon Cohen
Worldwide Contacts
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