CD19 CART Long Term Follow Up (LTFU) Study



Status:Recruiting
Healthy:No
Age Range:Any
Updated:3/31/2019
Start Date:November 2, 2015
End Date:May 17, 2035
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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Long Term Follow-Up of Patients Exposed to Lentiviral-Based CD19 Directed CAR T-Cell Therapy

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
CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (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 CD19 directed CAR T-Cell treatment and will be followed for 15 years
post treatment from the last CD19 directed CAR T-Cell treatment. Patients will be monitored
for safety and efficacy within the primary treatment protocols for the protocol defined
duration. While every effort will be made to keep patients in follow-up within the respective
treatment protocol itself, patients can drop off treatment protocols at any time. 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 CD19 CART
therapy within the concept of a single protocol.

Collection of such long term effects of CD19 CART cell therapy will help to further define
the risk-benefit profile of CD19 CART.

Inclusion Criteria:

- All patients who have received anti-CD19 directed CART therapy and completed or
discontinued early from a Novartis sponsored treatment protocol that utilized
CD19-directed CART cells or from any CD19 CART 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.
We found this trial at
23
sites
Minneapolis, Minnesota 55455
Principal Investigator: Veronika Bachanova
Phone: 612-625-1610
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Stella M. Davies
Phone: 513-636-9292
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Brandon Hayes-Lattin
Phone: 503-346-1507
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Principal Investigator: John Magenau
Phone: 734-936-8538
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Gregory Yanik
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30308
Principal Investigator: Jonathon Cohen
Phone: 404-778-3708
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Atlanta, Georgia 30342
Principal Investigator: Muna Qayed
Phone: +1 404 785 2125
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Chicago, Illinois 60637
Principal Investigator: Michael R. Bishop
Phone: 773-834-0982
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Columbus, Ohio 43210
Principal Investigator: Samantha Jaglowski
Phone: 614-688-9494
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Dallas, Texas 75235
Principal Investigator: Theodore Laetsch, MD
Phone: 214-456-2726
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Durham, North Carolina 27705
Principal Investigator: Paul L. Martin
Phone: 919-668-2967
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Houston, Texas 77030
Principal Investigator: Jason Westin
Phone: 713-792-2171
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Kansas City, Missouri 64108
Principal Investigator: Gary Myers, MD
Phone: 816-302-6851
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Los Angeles, California 90027
Principal Investigator: Michael Pulsipher
Phone: 323-361-8670
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Christian Capitini
Phone: 608-890-8070
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Melbourne, Victoria
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New York, New York 10021
Principal Investigator: Koen Van Besien
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Philadelphia, Pennsylvania 19104
Principal Investigator: Stephan Grupp
Phone: 267-425-5837
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Noelle Frey
Phone: 215-898-9256
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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13400 East Shea Boulevard
Phoenix, Arizona 85054
Principal Investigator: Jose F. Leis
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Salt Lake City, Utah 84108
Principal Investigator: Michael Boyer, MD
Phone: 801-213-3395
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San Francisco, California 94115
Principal Investigator: Charalambos Andreadis
Phone: 415-514-6281
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Westwood, Kansas 66205
Principal Investigator: Joseph P McGuirk
Phone: 913-588-6029
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