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
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Melbourne,Victoria,3000,Australia
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Camperdown,Nsw,Australia
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Wien,A 1090,Austria
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Wien,1090,Austria
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Gent,9000,Belgium
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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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Montreal,Quebec,H3t 1c5,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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Wuerzburg,97080,Germany
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Frankfurt,60590,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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Muenchen,81377,Germany
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Regensburg,Bavaria,93053,Germany
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Ulm,89081,Germany
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Berlin,13353,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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Sendai city,Miyagi,980 8574,Japan
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Kyoto,606 8507,Japan
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Fukuoka city,Fukuoka,812-8582,Japan
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Sapporo city,Hokkaido,060 8648,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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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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Valencia,Comunidad Valenciana,46010,Spain
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Barcelona,08041,Spain
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Sevilla,Andalucia,41013,Spain
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Taipei,10002,Taiwan
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London,Se5 9rs,United Kingdom
UTSW/Children's Medical Center
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Dallas,Texas,75235,United States
Theodore Laetsch
Theodore Laetsch, MD
Beth Israel Deaconess Medical Cente
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Boston,Massachusetts,02215,United States
Jessica Liegel
Adam Sperling
The Childrens Hosp of Philadelphia
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Philadelphia,Pennsylvania,19104,United States
Noelle Frey
Stephan Grupp
University of Wisconsin Hospital and Clinics
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Madison,Wisconsin,53792,United States
Christian Capitini
UCSF Medical Center
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San Francisco,California,94143,United States
Charalambos Andreadis
University of Chicago Medical Center, Hematology & Oncology
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Chicago,Illinois,60637,United States
Michael R. Bishop
Ohio ST Compr Cancer Ctr James Hosp
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Columbus,Ohio,43210,United States
Samantha Jaglowski
Duke Unversity Medical Center SC - CTL019B2205J
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Durham,North Carolina,27705,United States
Paul L. Martin
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
University of Kansas Cancer Center SC
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Westwood,Kansas,66205,United States
Joseph P McGuirk
Stanford University Medical Center
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Stanford,California,94304,United States
Kara Davis
Cincinnati Children's Hospital Medical Center
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Cincinnati,Ohio,45229-3039,United States
Stella M. Davies
Children's Mercy Hospital SC
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Kansas City,Missouri,64108,United States
Gary D. Myers
Gary Myers, MD
University of Utah Clinical Trials Office
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Salt Lake City,Utah,84108,United States
Michael Boyer, MD
Michael Boyer
Emory University School of Medicine/Winship Cancer Institute
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Atlanta,Georgia,30322,United States
Jonathon Cohen
University of Michigan
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Ann Arbor,Michigan,48109-2800,United States
Gregory Yanik
Sabrina Hargrove
Childrens Healthcare of Atlanta
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Atlanta,Georgia,30342,United States
Muna Qayed
Oregon Health & Science University
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Portland,Oregon,97239,United States
Brandon Hayes-Lattin
Childrens Hospital Los Angeles
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Los Angeles,California,90027,United States
Alan Wayne
Worldwide Contacts
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