Last Update: Oct 28, 2025 Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy ClinicalTrials.gov Identifier: [NCT02445222](https://clinicaltrials.gov/ct2/show/NCT02445222) Novartis Reference Number:CCTL019A2205B [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## 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. Condition Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program Phase Phase3 Overall Status Recruiting Number of Participants1400 Start Date Nov 02, 2015 Completion Date Feb 22, 2036 Gender All Age(s) 0 Years - 100 Years (Child, Adult, Older Adult) ## Interventions Genetic ### Previously treated CAR-T patients Lentiviral-based CAR-T cell therapy ## 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. Australia #### Novartis Investigative Site Recruiting Melbourne,Victoria,3000,Australia #### Novartis Investigative Site Recruiting Camperdown,New South Wales,2050,Australia #### Novartis Investigative Site Recruiting Melbourne,Victoria,3004,Australia #### Novartis Investigative Site Recruiting Herston,Qld 4006,Australia #### Novartis Investigative Site Recruiting Murdoch,Western Australia,6150,Australia Austria #### Novartis Investigative Site Recruiting Salzburg,5020,Austria #### Novartis Investigative Site Recruiting Vienna,1090,Austria #### Novartis Investigative Site Recruiting Vienna,A 1090,Austria Belgium #### Novartis Investigative Site Recruiting Ghent,9000,Belgium Canada #### Novartis Investigative Site Recruiting Hamilton,Ontario,L8v 1c3,Canada #### Novartis Investigative Site Recruiting Toronto,Ontario,M5g 1x8,Canada #### Novartis Investigative Site Recruiting Montreal,Quebec,H1t 2m4,Canada #### Novartis Investigative Site Recruiting Montreal,Quebec,H3t 1c5,Canada China 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Emory University School of Medicine-Winship Cancer Institute Recruiting Atlanta,Georgia,30322,United States ###### Jonathon Cohen ###### Keshawna L. Sherer Phone: [404-778-3708](tel:404-778-3708) Email: ###### Sharah Triplett Email: #### Uni of Chi Medi Ctr Hema and Onco Recruiting Chicago,Illinois,60637,United States ###### Howie Weiner Phone: [773-834-0982](tel:773-834-0982) Email: ###### Linda Schroeder Phone: [773-834-0982](tel:773-834-0982) Email: ###### Michael R Bishop ###### Michael R. Bishop #### University of Kansas Cancer Center Recruiting Westwood,Kansas,66205,United States ###### Janie Smart Phone: [913-588-6029](tel:913-588-6029) Email: ###### Joseph P McGuirk ###### Maghen Farris Phone: [913-588-6029](tel:913-588-6029) Email: #### Uni Of Michigan Health System Recruiting Ann Arbor,Michigan,48109,United States ###### John Magenau ###### Michelle Smith Tucker Phone: [734-936-8538](tel:734-936-8538) Email: ###### Sabrina Hargrove Phone: [734-936-8538](tel:734-936-8538) Email: #### Children s Mercy Hospital Recruiting Kansas City,Missouri,64108,United States ###### Allison Miles Phone: [816-855-1886](tel:816-855-1886) Email: ###### Gary D. Myers ###### Gary Myers, MD ###### Rachel Wilcox Phone: [816-302-6851](tel:816-302-6851) Email: #### Duke Unversity Medical Center Recruiting Durham,North Carolina,27705,United States ###### Erin Arbuckle Phone: [919-684-3293](tel:919-684-3293) Email: ###### Kristine Edwards Phone: [919-668-2967](tel:919-668-2967) Email: ###### Nelson Chao Email: ###### Paul L. Martin #### Cinn Children Hosp Medical Center Recruiting Cincinnati,Ohio,45229-3039,United States ###### Kristie Evans Stricker Phone: [+1 513 636 9292]() Email: ###### Melanie Jordan Phone: [513-636-9292](tel:513-636-9292) Email: ###### Stella M. Davies #### Oregon Health Sciences University Recruiting Portland,Oregon,97239,United States ###### Beth Zentzis Phone: [503-346-1507](tel:503-346-1507) Email: ###### Brandon Hayes-Lattin ###### Mai-Lee Lee Yap Phone: [+1 503 494 6865]() Email: #### The Childrens Hosp of Philadelphia Recruiting Philadelphia,Pennsylvania,19104,United States ###### Desire Fenderson Phone: [215-615-1725](tel:215-615-1725) Email: ###### Lauren Vernau Phone: [215-590-7399](tel:215-590-7399) Email: ###### Michelle Caylor Phone: [215-898-9256](tel:215-898-9256) Email: ###### Noelle Frey ###### Stephan Grupp #### UTSW/Children's Medical Center Recruiting Dallas,Texas,75235,United States ###### Alison Patterson Phone: [214-456-2726](tel:214-456-2726) Email: ###### Theodore Laetsch, MD ###### Theodore Laetsch #### MD Anderson Cancer Center Recruiting Houston,Texas,77030,United States ###### Jason Westin ###### Laura Hargraves Phone: [713-792-6594](tel:713-792-6594) Email: ###### Souzanne T Ouzounian Phone: [713-792-2171](tel:713-792-2171) Email: ###### Souzanne T. Ouzounian Phone: [713-792-2171](tel:713-792-2171) Email: #### University of Utah Clinical Trials Office Recruiting Salt Lake City,Utah,84108,United States ###### Luke Stone Phone: [801-213-3395](tel:801-213-3395) Email: ###### Michael Boyer, MD ###### Michael Boyer ###### Michael Pulsipher ###### Sydney Goosen Phone: [801-213-3401](tel:801-213-3401) Email: #### University of Wisconsin Hospital Recruiting Madison,Wisconsin,53792,United States ###### Celeste Matsushima Phone: [+1 608-890-8069]() Email: ###### Christian Capitini ###### Jenny Weiland Phone: [608-890-8070](tel:608-890-8070) Email: ###### Kreg M Grindle Email: #### Childrens Hospital Los Angeles Recruiting Los Angeles,California,90027,United States ###### Alan Wayne ###### Lee Chen Phone: [323-361-5812](tel:323-361-5812) Email: #### UCSF Medical Center Recruiting San Francisco,California,94143,United States ###### Charalambos Andreadis ###### Jenai Wilmoth Phone: [415-514-6281](tel:415-514-6281) Email: #### Stanford University Medical Center Recruiting Stanford,California,94304,United States ###### Christina Baggott Phone: [650-723-4000](tel:650-723-4000) Email: ###### Kara Davis #### Childrens Healthcare of Atlanta Recruiting Atlanta,Georgia,30342,United States ###### Audry Grizzle Tumlin Phone: [+1 404 785 2125]() Email: ###### Muna Qayed #### Beth Israel Deaconess Med Center Recruiting Boston,Massachusetts,02215,United States Phone: [617-632-3985](tel:617-632-3985) Phone: [617-667-7000](tel:617-667-7000) ###### Adam Sperling ###### Jacalyn Rosenblatt #### University of Michigan Recruiting Ann Arbor,Michigan,48109-2800,United States ###### Gregory Yanik ###### Sabrina Hargrove Email: #### Ohio ST Compr Cancer Ctr James Hosp Recruiting Columbus,Ohio,43210,United States ###### David A Bond ###### Molly Vittorio Phone: [614-688-9494](tel:614-688-9494) Email: #### Massachusetts General Hospital Recruiting Boston,Massachusetts,02114,United States ###### Matthew Frigault #### City of Hope National Medical Center Recruiting Duarte,California,91010 3000,United States ###### Leslie Popplewell #### UCLA Medical Center Recruiting Los Angeles,California,90095,United States Phone: [310-825-4493](tel:310-825-4493) ###### Aravind Ramakrishnan #### Wayne State University-Karmanos Cancer Institute Recruiting Detroit,Michigan,48201,United States Phone: [313-576-8716](tel:313-576-8716) ###### Abhinav Deol #### University of Texas Southwestern Medical Center Recruiting Dallas,Texas,75390,United States ###### Cris Molina Phone: [214-648-6449](tel:214-648-6449) Email: ###### Samuel John #### Thomas Jefferson University Recruiting Philadelphia,Pennsylvania,19107,United States Phone: [215-955-8699](tel:215-955-8699) ###### Usama Gergis #### Sarah Cannon Research Institute Recruiting Nashville,Tennessee,37203,United States ###### Ian W Flinn ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: [](mailto:)