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
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Melbourne,Victoria,3000,Australia
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Camperdown,NSW,Australia
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Parkville,Victoria,3052,Australia
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Wien,A 1090,Austria
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Gent,9000,Belgium
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Montreal,Quebec,H1T 2M4,Canada
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Toronto,Ontario,M5G 1X8,Canada
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Montreal,Quebec,H3T 1C5,Canada
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Hamilton,Ontario,L8V 1C3,Canada
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Copenhagen,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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Berlin,13353,Germany
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Wuerzburg,97080,Germany
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Leipzig,04103,Germany
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Hamburg,20246,Germany
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Ulm,89081,Germany
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Muenchen,81377,Germany
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Frankfurt,60590,Germany
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Regensburg,Bavaria,93053,Germany
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Koeln,50937,Germany
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Tel Aviv,6423906,Israel
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Ramat Gan,52621,Israel
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Roma,RM,00165,Italy
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Monza,MB,20900,Italy
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Kyoto,606 8507,Japan
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Chuo ku,Tokyo,104 0045,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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Fukuoka city,Fukuoka,812-8582,Japan
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Oslo,0424,Norway
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Oslo,NO 0424,Norway
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Singapore,169608,Singapore
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Salamanca,Castilla Y Leon,37007,Spain
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Madrid,28009,Spain
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Valencia,Comunidad Valenciana,46010,Spain
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Sevilla,Andalucia,41013,Spain
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Esplugues De Llobregat,Barcelona,08950,Spain
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Madrid,28041,Spain
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Barcelona,Catalunya,08035,Spain
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Hospitalet de LLobregat,Catalunya,08907,Spain
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Madrid,28046,Spain
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Barcelona,08041,Spain
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Taipei,10002,Taiwan
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London,SE5 9RS,United Kingdom
UCSF Medical Center .
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San Francisco,Carey Kokkonen (415-514-6281) email: [email protected] -- Charalambos Andreadis,94143 - California,United States
University of Utah Clinical Trials Office
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Salt Lake City,Luke Stone (801-213-3395) email: [email protected] -- Michael Boyer, MD -- Michael Boyer,84108 - Utah,United States
Cincinnati Children's Hospital Medical Center
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Cincinnati,Melanie Jordan (513-636-9292) email: [email protected] -- Stella M. Davies,45229-3039 - Ohio,United States
University of Chicago Medical Center, Hematology & Oncology
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Chicago,Howie Weiner (773-834-0982) email: [email protected] -- Michael R. Bishop,60637 - Illinois,United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State Univ.
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Columbus,Poesha Smith (614-688-9494) email: [email protected] -- Samantha Jaglowski,43210 - Ohio,United States
University of Wisconsin Hospital and Clinics
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Madison,Jenny Weiland (608-890-8070) email: [email protected] -- Celeste Matsushima (+1 608-890-8069) email: [email protected] -- Christian Capitini,53792 - Wisconsin,United States
Duke Unversity Medical Center SC - CTL019B2205J
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Durham,Kristine Edwards (919-668-2967) email: [email protected] -- Erin Arbuckle (919-684-3293) email: [email protected] -- Paul L. Martin,27705 - North Carolina,United States
University of Kansas Cancer Center SC
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Westwood,Janie Smart (913-588-6029) email: [email protected] -- Joseph P McGuirk,66205 - Kansas,United States
Oregon Health & Science University
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Portland,Beth Zentzis (503-346-1507) email: [email protected] -- Brandon Hayes-Lattin,97239 - Oregon,United States
UTSW/Children's Medical Center
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Dallas,Alison Patterson (214-456-2726) email: [email protected] -- Theodore Laetsch, MD -- Theodore Laetsch,75235 - Texas,United States
Emory University School of Medicine/Winship Cancer Institute
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Atlanta,Keshawna L. Sherer (404-778-3708) email: [email protected] -- Jonathon Cohen,30322 - Georgia,United States
University of Michigan .
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Ann Arbor,Connie Varner email: [email protected] -- Gregory Yanik,48109-2800 - Michigan,United States
MD Anderson Cancer Center SC
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Houston,Souzanne T. Ouzounian (713-792-2171) email: [email protected] -- Laura Hargraves (713-792-6594) email: [email protected] -- Jason Westin,77030 - Texas,United States
University of Michigan Health System SC CTL019
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Ann Arbor,Michelle Smith Tucker (734-936-8538) email: [email protected] -- John Magenau,48109 - Michigan,United States
Children's Healthcare of Atlanta SC CTL019
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Atlanta,Sarah Votaw (404-785-2125) email: [email protected] -- Muna Qayed,30342 - Georgia,United States
Stanford Universtiy Medical Center SC - CTL019B2205J - B2206
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Stanford,Michael Kunicki (650-725-1662) email: [email protected] -- Kara Davis,94304 - California,United States
University of Minnesota SC-4
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Minneapolis,Danielle Jin (612-625-1610) email: [email protected] -- Veronika Bachanova,55455 - Minnesota,United States
Children's Mercy Hospital SC
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Kansas City,Rachel Wilcox (816-302-6851) email: [email protected] -- Gary Myers, MD -- Gary D. Myers,64108 - Missouri,United States
University of Pennsylvania
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Philadelphia,Michelle Caylor (215-898-9256) email: [email protected] -- Noelle Frey,19104 - Pennsylvania,United States
Childrens Hospital Los Angeles SC CTL019
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Los Angeles,Lee Chen (323-361-8670) email: [email protected] -- Alan Wayne,90027 - California,United States
Worldwide Contacts
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