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
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Parkville,Victoria,3052,Australia
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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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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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Berlin,13353,Germany
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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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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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Sapporo city,Hokkaido,060 8648,Japan
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Sendai city,Miyagi,980 8574,Japan
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Chuo ku,Tokyo,104 0045,Japan
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Kyoto,606 8507,Japan
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Fukuoka city,Fukuoka,812-8582,Japan
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Utrecht,3584cx,Netherlands
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Oslo,0424,Norway
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Oslo,0310,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
Oregon Health & Science University
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Portland,Oregon,97239,United States
Brandon Hayes-Lattin
Emory University School of Medicine/Winship Cancer Institute
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Atlanta,Georgia,30322,United States
Jonathon Cohen
MD Anderson Cancer Center SC
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Houston,Texas,77030,United States
Jason Westin
Dana Farber Cancer Institute Harvard Cancer Center
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Boston,Massachusetts,02215,United States
Adam Sperling
Jessica Liegel
Childrens Hospital Los Angeles SC CTL019
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Los Angeles,California,90027,United States
Alan Wayne
University of Wisconsin Hospital and Clinics
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Madison,Wisconsin,53792,United States
Christian Capitini
Duke Unversity Medical Center SC - CTL019B2205J
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Durham,North Carolina,27705,United States
Paul L. Martin
University of Pennsylvania
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Philadelphia,Pennsylvania,19104,United States
Noelle Frey
Stephan Grupp
University of Kansas Cancer Center SC
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Westwood,Kansas,66205,United States
Joseph P McGuirk
University of Minnesota SC-4
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Minneapolis,Minnesota,55455,United States
Veronika Bachanova
Childrens Healthcare of Atlanta SC CTL019
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Atlanta,Georgia,30342,United States
Muna Qayed
UCSF Medical Center .
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San Francisco,California,94143,United States
Charalambos Andreadis
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 Michigan .
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Ann Arbor,Michigan,48109-2800,United States
Connie Varner
Gregory Yanik
University of Utah Clinical Trials Office
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Salt Lake City,Utah,84108,United States
Michael Boyer, MD
Michael Boyer
UTSW/Children's Medical Center
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Dallas,Texas,75235,United States
Theodore Laetsch, MD
Theodore Laetsch
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 Ohio State Univ.
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Columbus,Ohio,43210,United States
Samantha Jaglowski
Stanford University Medical Center SC - CTL019B2205J - B2206
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Stanford,California,94304,United States
Kara Davis
University of Michigan Health System SC CTL019
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Ann Arbor,Michigan,48109,United States
John Magenau
Worldwide Contacts
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