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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001673-14 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously treated CAR-T patients | Other | Patients who previously were exposed to lentiviral-based CART cell therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Previously treated CAR-T patients | Genetic | Lentiviral-based CAR-T cell therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with certain events (see description) | The percentage of pts with listed categories: New secondary malignancies, new serious infection, new incidence of serious neurologic disorder, New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder, New incidence of a hematologic disorder | at M3 post treatment, M6, M9, M12 and then, every 6M up to year 5, yearly until year 15. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre- specified time points | at M3 post treatment, M6, M9, M12 and every 6M up to year 5, yearly until year 15. | |
| Percentage of patients with detectable RCL by VSV-G |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | ||
| Novartis Pharmaceuticals | Contact | +41613241111 |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Completed | Phoenix | Arizona | 85054 | United States | |
| City of Hope National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41252666 | Derived | Maziarz RT, Bishop MR, Tam CS, Borchmann P, Worel N, McGuirk JP, Holte H, Waller EK, Jaglowski S, Andreadis C, Foley SR, Westin JR, Fleury I, Ho PJ, Mielke S, Teshima T, Janakiram M, Hsu J, Izutsu K, Kersten MJ, Ghosh M, Wagner-Johnston N, Kato K, Corradini P, Ma W, Han X, Nuortti M, Awasthi R, Mundt KE, Majdan M, Maier HJ, Jegerlehner A, Salles G, Schuster SJ. Five-Year Analysis of the JULIET Trial of Tisagenlecleucel in Patients With Relapsed/Refractory Large B-Cell Lymphoma. J Clin Oncol. 2026 Jan 10;44(2):86-91. doi: 10.1200/JCO-25-00507. Epub 2025 Nov 18. |
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| at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15 |
| Percentage of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death | at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15. |
| B- and T- lymphocyte count | at M3 post treatment then M6, M9, M12 and every 6M up to year 5, yearly until year 15. |
| Height and weight, Tanner staging, menstruation status | at M3 post treatment then M6, M12 and every year until year 15. |
| Recruiting |
| Duarte |
| California |
| 91010 3000 |
| United States |
|
| Childrens Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
|
| UCLA Medical Center | Recruiting | Los Angeles | California | 90095 | United States |
|
| UCSF Medical Center | Recruiting | San Francisco | California | 94143 | United States |
|
| Stanford University Medical Center | Recruiting | Stanford | California | 94304 | United States |
|
| Emory University School of Medicine-Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Emory University School of Medicine/Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Childrens Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 30342 | United States |
|
| Uni of Chi Medi Ctr Hema and Onco | Recruiting | Chicago | Illinois | 60637 | United States |
|
| University of Chicago Medical Center, Hematology & Oncology | Recruiting | Chicago | Illinois | 60637 | United States |
|
| University of Kansas Cancer Center SC | Recruiting | Westwood | Kansas | 66205 | United States |
|
| University of Kansas Cancer Center | Recruiting | Westwood | Kansas | 66205 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Beth Israel Deaconess Med Center | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109-2800 | United States |
|
| Uni Of Michigan Health System | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| University of Michigan Health System SC CTL019 | Recruiting | Ann Arbor | Michigan | 48109 | United States |
|
| Wayne State University-Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
|
| University of Minnesota | Withdrawn | Minneapolis | Minnesota | 55455 | United States |
| Children s Mercy Hospital | Recruiting | Kansas City | Missouri | 64108 | United States |
|
| Children's Mercy Hospital SC | Recruiting | Kansas City | Missouri | 64108 | United States |
|
| Weill Cornell Medical College | Withdrawn | New York | New York | 10065 | United States |
| Duke Unversity Medical Center SC - CTL019B2205J | Recruiting | Durham | North Carolina | 27705 | United States |
|
| Duke Unversity Medical Center | Recruiting | Durham | North Carolina | 27705 | United States |
|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229-3039 | United States |
|
| Cinn Children Hosp Medical Center | Recruiting | Cincinnati | Ohio | 45229-3039 | United States |
|
| Ohio ST Compr Cancer Ctr James Hosp | Recruiting | Columbus | Ohio | 43210 | United States |
|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
|
| Oregon Health Sciences University | Recruiting | Portland | Oregon | 97239 | United States |
|
| The Childrens Hosp of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| UTSW/Children's Medical Center | Recruiting | Dallas | Texas | 75235 | United States |
|
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
|
| MD Anderson Cancer Center SC | Recruiting | Houston | Texas | 77030 | United States |
|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| University of Utah Clinical Trials Office | Recruiting | Salt Lake City | Utah | 84108 | United States |
|
| University of Utah Clinical Trials Office | Recruiting | Salt Lake City | Utah | 84108 | United States |
|
| University of Wisconsin Hospital and Clinics | Recruiting | Madison | Wisconsin | 53792 | United States |
|
| University of Wisconsin Hospital | Recruiting | Madison | Wisconsin | 53792 | United States |
|
| Novartis Investigative Site | Recruiting | Camperdown | New South Wales | 2050 | Australia |
| Novartis Investigative Site | Recruiting | Melbourne | Victoria | 3000 | Australia |
| Novartis Investigative Site | Recruiting | Melbourne | Victoria | 3004 | Australia |
| Novartis Investigative Site | Withdrawn | Parkville | Victoria | 3052 | Australia |
| Novartis Investigative Site | Recruiting | Murdoch | Western Australia | 6150 | Australia |
| Novartis Investigative Site | Recruiting | Herston | QLD 4006 | Australia |
| Novartis Investigative Site | Withdrawn | Linz | 4020 | Austria |
| Novartis Investigative Site | Recruiting | Salzburg | 5020 | Austria |
| Novartis Investigative Site | Recruiting | Vienna | 1090 | Austria |
| Novartis Investigative Site | Recruiting | Vienna | A 1090 | Austria |
| Novartis Investigative Site | Recruiting | Ghent | 9000 | Belgium |
| 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 |
| Novartis Investigative Site | Recruiting | Beijing | 100036 | China |
| Novartis Investigative Site | Recruiting | Copenhagen | DK-2100 | Denmark |
| Novartis Investigative Site | Recruiting | Helsinki | 00029 | Finland |
| Novartis Investigative Site | Recruiting | Nantes | 44093 | France |
| Novartis Investigative Site | Recruiting | Paris | 75019 | France |
| Novartis Investigative Site | Recruiting | Paris | 75475 | France |
| Novartis Investigative Site | Recruiting | Pierre-Bénite | 69495 | France |
| Novartis Investigative Site | Recruiting | Villejuif | 94800 | France |
| Novartis Investigative Site | Recruiting | Munich | Bavaria | 81377 | Germany |
| Novartis Investigative Site | Recruiting | Regensburg | Bavaria | 93053 | Germany |
| Novartis Investigative Site | Recruiting | Würzburg | Bavaria | 97080 | Germany |
| Novartis Investigative Site | Recruiting | Frankfurt am Main | Hesse | 60590 | Germany |
| Novartis Investigative Site | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Novartis Investigative Site | Recruiting | Leipzig | Saxony | 04103 | Germany |
| Novartis Investigative Site | Recruiting | Berlin | 13353 | Germany |
| Novartis Investigative Site | Recruiting | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Recruiting | Ulm | 89081 | Germany |
| Novartis Investigative Site | Recruiting | Chaïdári | 124 62 | Greece |
| Novartis Investigative Site | Recruiting | Hong Kong | Hong Kong |
| Novartis Investigative Site | Recruiting | Ramat Gan | 5265601 | Israel |
| Novartis Investigative Site | Recruiting | Tel Aviv | 6423906 | Israel |
| Novartis Investigative Site | Recruiting | Bologna | BO | 40138 | Italy |
| Novartis Investigative Site | Recruiting | Monza | MB | 20900 | Italy |
| Novartis Investigative Site | Recruiting | Milan | MI | 20132 | Italy |
| Novartis Investigative Site | Recruiting | Milan | MI | 20133 | Italy |
| Novartis Investigative Site | Recruiting | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Recruiting | Roma | RM | 00165 | Italy |
| Novartis Investigative Site | Recruiting | Roma | RM | 00168 | Italy |
| Novartis Investigative Site | Recruiting | Fukuoka | Fukuoka | 812-8582 | Japan |
| Novartis Investigative Site | Recruiting | Sapporo | Hokkaido | 060 8648 | Japan |
| Novartis Investigative Site | Recruiting | Sendai | Miyagi | 980 8574 | Japan |
| Novartis Investigative Site | Withdrawn | Chuo Ku | Tokyo | 104 0045 | Japan |
| Novartis Investigative Site | Recruiting | Kyoto | 606 8507 | Japan |
| Novartis Investigative Site | Completed | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Novartis Investigative Site | Completed | Utrecht | 3584 CS | Netherlands |
| Novartis Investigative Site | Withdrawn | Utrecht | 3584 CX | Netherlands |
| Novartis Investigative Site | Recruiting | Oslo | 0310 | Norway |
| Novartis Investigative Site | Recruiting | Oslo | 0424 | Norway |
| Novartis Investigative Site | Recruiting | Riyadh | 11211 | Saudi Arabia |
| Novartis Investigative Site | Recruiting | Singapore | 119074 | Singapore |
| Novartis Investigative Site | Recruiting | Singapore | 169608 | Singapore |
| Novartis Investigative Site | Recruiting | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Recruiting | Esplugues | Barcelona | 08950 | Spain |
| Novartis Investigative Site | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Novartis Investigative Site | Recruiting | Salamanca | Castille and León | 37007 | Spain |
| Novartis Investigative Site | Recruiting | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Recruiting | Pamplona | Navarre | 31008 | Spain |
| Novartis Investigative Site | Recruiting | Barcelona | 08041 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 28009 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 28041 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 28046 | Spain |
| Novartis Investigative Site | Recruiting | Seville | 41013 | Spain |
| Novartis Investigative Site | Recruiting | Valencia | 46010 | Spain |
| Novartis Investigative Site | Recruiting | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Recruiting | Birmingham | B15 2TH | United Kingdom |
| Novartis Investigative Site | Recruiting | London | SE5 9RS | United Kingdom |