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,New South Wales,2050,Australia
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Melbourne,Victoria,3004,Australia
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Herston,Qld 4006,Australia
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Murdoch,Western Australia,6150,Australia
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Vienna,A 1090,Austria
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Salzburg,5020,Austria
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Vienna,1090,Austria
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Ghent,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,75475,France
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Paris,75019,France
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Pierre-Bénite,69495,France
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Nantes,44093,France
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Villejuif,94800,France
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Regensburg,Bayern,93053,Germany
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Berlin,13353,Germany
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Hamburg,20246,Germany
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Cologne,50937,Germany
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Munich,Bavaria,81377,Germany
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Ulm,89081,Germany
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Würzburg,Bavaria,97080,Germany
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Frankfurt am Main,Hesse,60590,Germany
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Leipzig,Saxony,04103,Germany
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Hong Kong,Hong Kong
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Tel Aviv,6423906,Israel
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Ramat Gan,5265601,Israel
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Monza,MB,20900,Italy
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Roma,RM,00165,Italy
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Milan,MI,20133,Italy
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Rozzano,MI,20089,Italy
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Bologna,BO,40138,Italy
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Milan,MI,20132,Italy
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Roma,RM,00168,Italy
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Fukuoka,Fukuoka,812-8582,Japan
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Sapporo,Hokkaido,060 8648,Japan
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Sendai,Miyagi,980 8574,Japan
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Kyoto,606 8507,Japan
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Seoul,03722,Korea, Republic of
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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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Seoul,03722,South Korea
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Seville,Andalusia,41013,Spain
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Esplugues de Llobregat,Barcelona,08950,Spain
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Salamanca,Castille and León,37007,Spain
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Barcelona,Catalonia,08035,Spain
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Barcelona,08041,Spain
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Madrid,28009,Spain
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Madrid,28041,Spain
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Madrid,28046,Spain
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Pamplona,Navarre,31008,Spain
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L'Hospitalet de Llobregat,Barcelona,08907,Spain
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Valencia,46010,Spain
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Taipei,10002,Taiwan
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London,Se5 9rs,United Kingdom
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Birmingham,B15 2th,United Kingdom
Emory University School of Medicine-Winship Cancer Institute
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Atlanta,Georgia,30322,United States
Jonathon Cohen
Sharah Triplett
Uni of Chi Medi Ctr Hema and Onco
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Chicago,Illinois,60637,United States
Michael R Bishop
Michael R. Bishop
University of Kansas Cancer Center
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Westwood,Kansas,66205,United States
Joseph P McGuirk
Beth Israel Deaconess Med Center
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Boston,Massachusetts,02215,United States
Adam Sperling
Jacalyn Rosenblatt
Uni Of Michigan Health System
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Ann Arbor,Michigan,48109,United States
John Magenau
Children s Mercy Hospital
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Kansas City,Missouri,64108,United States
Gary D. Myers
Gary Myers, MD
Duke Unversity Medical Center
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Durham,North Carolina,27705,United States
Nelson Chao
Paul L. Martin
Cinn Children Hosp Medical Center
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Cincinnati,Ohio,45229-3039,United States
Stella M. Davies
Oregon Health Sciences University
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Portland,Oregon,97239,United States
Brandon Hayes-Lattin
The Childrens Hosp of Philadelphia
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Philadelphia,Pennsylvania,19104,United States
Noelle Frey
Stephan Grupp
UTSW/Children's Medical Center
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Dallas,Texas,75235,United States
Theodore Laetsch, MD
Theodore Laetsch
MD Anderson Cancer Center
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Houston,Texas,77030,United States
Jason Westin
University of Utah Clinical Trials Office
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Salt Lake City,Utah,84108,United States
Michael Boyer, MD
Michael Boyer
Michael Pulsipher
University of Wisconsin Hospital
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Madison,Wisconsin,53792,United States
Christian Capitini
Kreg M Grindle
Childrens Hospital Los Angeles
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Los Angeles,California,90027,United States
Alan Wayne
UCSF Medical Center
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San Francisco,California,94143,United States
Charalambos Andreadis
Stanford University Medical Center
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Stanford,California,94304,United States
Kara Davis
Childrens Healthcare of Atlanta
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Atlanta,Georgia,30342,United States
Muna Qayed
University of Michigan
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Ann Arbor,Michigan,48109-2800,United States
Gregory Yanik
Sabrina Hargrove
Ohio ST Compr Cancer Ctr James Hosp
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Columbus,Ohio,43210,United States
David A Bond
Massachusetts General Hospital
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Boston,Massachusetts,02114,United States
Matthew Frigault
City of Hope National Medical Center
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Duarte,California,91010 3000,United States
Leslie Popplewell
UCLA Medical Center
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Los Angeles,California,90095,United States
Aravind Ramakrishnan
Wayne State University-Karmanos Cancer Institute
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Detroit,Michigan,48201,United States
Abhinav Deol
University of Texas Southwestern Medical Center
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Dallas,Texas,75390,United States
Samuel John
Worldwide Contacts
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