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Tisagenlecleucel
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Journal Articles
Ariel Perez Perez, MD, Christina A Bachmeier, PharmD, Renee Smilee, Albert J Ribickas, Aleksandr Lazaryan, MDPhDMPH, Julio C. Chavez, MD, Claudio Anasetti, MD, Bijal Shah, MD, Farhad Khimani, MBBS, Taiga Nishihori, MD, Marco L. Davila, MD PhD, Frederick L. Locke, MD, Michael D. Jain, MDPhD, Hien D. Liu, MD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 4–5.
Published: 2020
... with relapsed/refractory diffuse large B cell lymphoma (DLBCL) who underwent leukapheresis for Kymriah® (tisagenlecleucel) at our institution from May 1 st , 2018 to July 1 st , 2020. The study was approved by the Institutional Review Board. Non-stimulated mononuclear cell (MNC) collections were performed...
Journal Articles
Ulrich Jaeger, MD, Michael R. Bishop, MD, Gilles Salles, MDPhD, Stephen J. Schuster, MD, Richard T. Maziarz, MD, Xia Han, MS, Alexander Savchenko, MD, Nathan Roscoe, Mbt, Elena Orlando, PhD, Dawson Knoblock, PhD, Ranjan Tiwari, MSc, Lida Bubuteishvili Pacaud, MD, Paolo Corradini
Journal:
Blood
Blood (2020) 136 (Supplement 1): 48–49.
Published: 2020
...: Tisagenlecleucel (tisa-cel; autologous anti-CD19 CAR-T cell therapy) has demonstrated durable responses and a manageable safety profile in adult pts with r/r DLBCL in the JULIET trial. Here we report updated efficacy results with a 40 month median follow-up and associations with baseline Myc overexpression...
Journal Articles
Adrian Minson, MBBS,FRACP,FRCPA, Nada Hamad, MBBS,BSc,MSc,FRACP FRCPA, Jason P Butler, MBBS, MMedSc, FRACP, FRCPA, David Alan Westerman, MBBS, FRCPA, FRACP, David Ritchie, MB ChB, PhD FRACP, FRCPA, Piers Blombery, MBBS, John F. Seymour, Constantine S. Tam, MBBS, Michael Dickinson, DMed Sci
Journal:
Blood
Blood (2020) 136 (Supplement 1): 34–35.
Published: 2020
... of brexucabtagene autoleucel in MCL. Rationale Tisagenlecleucel (Novartis) is a CAR T-cell product directed against CD19 that is approved in many countries for the treatment of relapsed DLBCL and ALL. MCL consistently expresses CD19 at diagnosis and relapse and is therefore a promising target. Pre-clinical data...
Journal Articles
Julio C. Chavez, MD, Frederick L. Locke, MD, Ellen Napier, CRNP, Carl Simon, MS, Andrew Lewandowski, PhD, Rakesh Awasthi, PhD, Boris Engels, PhD, Petrina Georgala, PhD, Attilio Bondanza, MD, Stephen J. Schuster, MD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 3–4.
Published: 2020
...Julio C. Chavez, MD; Frederick L. Locke, MD; Ellen Napier, CRNP; Carl Simon, MS; Andrew Lewandowski, PhD; Rakesh Awasthi, PhD; Boris Engels, PhD; Petrina Georgala, PhD; Attilio Bondanza, MD; Stephen J. Schuster, MD Background: Tisagenlecleucel (tisa-cel), an autologous anti-CD19 chimeric antigen...
Journal Articles
Veit Buecklein, MD, Viktoria Blumenberg, MD, Josephine Ackermann, Christian Schmidt, MD, Kai Rejeski, MD, Niklas Mueller, MD, Anna Reischer, MD, Louisa von Baumgarten, MD, Florian Schoeberl, MD, Andreas Humpe, MD, Michael von Bergwelt, MD PhD, Marion Subklewe, MD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 34–35.
Published: 2020
Journal Articles
Gloria Iacoboni, MD, Josu Iraola-Truchuelo, Nuria Martinez-Cibrian, MD, Rebeca Bailén, MD, Lucia Lopez Corral, PhD MD, Jose M. Sanchez, MD, Manuel Guerreiro, MD, ANA Carolina Carolina CABALLERO González, Alberto Mussetti, MD, Juan-Manuel Sancho, MD PhD, Rafael Hernani, MD, Carlos Solano, MD PhD, Anna Sureda Balari, MD PhD, Javier Briones, MD PhD, Alejandro Martin Garcia-Sancho, MD PhD, Mi Kwon, MD PhD, Juan Luis Reguera, MD PhD, Pere Barba, MD PhD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 19–21.
Published: 2020
...; Anna Sureda Balari, MD PhD; Javier Briones, MD PhD; Alejandro Martin Garcia-Sancho, MD PhD; Mi Kwon, MD PhD; Juan Luis Reguera, MD PhD; Pere Barba, MD PhD Introduction Tisagenlecleucel (tisa-cel) is a second generation, CD19-targeted Chimeric Antigen Receptor (CAR) T-cell therapy for relapsed...
Journal Articles
Michael W Boyer, MD, Sonali Chaudhury, MBBS,MD, Kara L Davis, DO, Timothy Alan Driscoll, MD, Stephan A Grupp, MD PhD, Michelle Hermiston, MD PhD, Samuel John, MD, Amy K Keating, MD PhD, Christina Kovacs, BS, JD, Andrea Magley, BS, Gary Douglas Myers, MD, Christine L Phillips, MD, Michael A Pulsipher, MD, Das Purkayastha, PhD, Julie-An Talano, MD, Jennifer Willert, MD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 23–24.
Published: 2020
... A Pulsipher, MD; Das Purkayastha, PhD; Julie-An Talano, MD; Jennifer Willert, MD Background: Tisagenlecleucel is an anti-CD19 chimeric antigen receptor (CAR)-T cell therapy approved for pediatric and young adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and adult...
Journal Articles
Journal:
Blood
Blood (2020) 136 (Supplement 1): 12.
Published: 2020
...Marjorie E Zettler, PhD MPH; Bruce Feinberg, DO; Alexandrina Balanean; Ajeet Gajra, MD MBBS Introduction: Tisagenlecleucel (tisa-cel) is a chimeric antigen receptor (CAR) T-cell therapy approved by the United States (US) Food and Drug Administration (FDA) for the treatment of patients up to 25...
Journal Articles
Agrima Mian, MBBS, MD, Wei Wei, MS, Brian T. Hill, MD, Betty K. Hamilton, MD, Allison M. Winter, MD, Jack Khouri, MD, Brad Pohlman, MD, Deepa Jagadeesh, MDMPH, Alex V. Mejia Garcia, MD, Faiz Anwer, MD, Aaron T. Gerds, MDMS, Matt Kalaycio, MD, Robert M. Dean, MD, Ronald Sobecks, MD, Navneet S. Majhail, MD MS
Journal:
Blood
Blood (2020) 136 (Supplement 1): 38–39.
Published: 2020
... systematically compared. We characterized institutional resources used around Tisagenlecleucel (tisa-cel) and Axicabtagene ciloleucel (axi-cel) infusion and identified factors that led to longer hospitalization during the first 100 days of therapy. Methods We reviewed medical records of consecutive adult...
Journal Articles
Nathan H Fowler, MD, Michael Dickinson, DMed Sci, Martin Dreyling, MD, Joaquin Martinez-Lopez, MD, Arne Kolstad, MD PhD, Jason P Butler, MBBS, MMedSc, FRACP, FRCPA, Monalisa Ghosh, MD, Leslie L. Popplewell, MD FACP, Julio C. Chavez, MD, Emmanuel Bachy, MD PhD, Koji Kato, MD PhD, Hideo Harigae, MD PhD, Marie José Kersten, MD PhD, Charalambos Andreadis, MD, Peter A. Riedell, MD, P. Joy Ho, MB.BS. (Hons), D.Phil (Oxon), FRACP, FRCPA, FFSc(RCPA), Jose Antonio Pérez-Simón, MD, Sarah J. Nagle, MD, Loretta J. Nastoupil, MD, Bastian von Tresckow, MD, Andres JM Ferreri, MD, Takanori Teshima, MD, Piers Patten, MD PhD, Joseph P. McGuirk, DO, Andreas Petzer, MD, Fritz C. Offner, MD PhD, Andreas Viardot, Professor Dr, Pier Luigi Zinzani, MD, Ram Malladi, MBBS(Lond), MRCP(UK), FRCPath, Lida Bubuteishvili Pacaud, MD, Alessandra Forcina, MD, Aiesha Zia, Stephen J. Schuster, MD, Catherine Thieblemont, MD PhD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 1–3.
Published: 2020
... Background: Follicular lymphoma (FL) remains an incurable disease for most patients (pts), characterized by a relapsing and remitting pattern. For pts with relapsed/refractory (r/r) FL, treatment outcomes typically worsen with each subsequent line of therapy, highlighting an unmet need. Tisagenlecleucel...
Journal Articles
Jenna Rossoff, MD, Christina Baggott, RN, PhD, Snehit Prabhu, PhD, Holly Pacenta, MD, Christine L Phillips, MD, Heather Stefanski, MDPhD, Julie-An Talano, MD, Amy Moskop, MD, Steven P. Margossian, MD PhD, Michael R Verneris, MD, Gary Douglas Myers, MD, Nicole Karras, MD, Patrick A. Brown, MD, Muna Qayed, MDMSc, Michelle Hermiston, MD PhD, Prakash Satwani, MD, Christa Krupski, DO, MPH, Amy Keating, MD, Rachel Wilcox, Cara A Rabik, MDPhD, Vanessa Fabrizio, MD, Michael Kunicki, Vasant Chinnabhandar, MD, A. Yasemin Goksenin, MD PhD MA, MPH, Kevin J. Curran, MD, Crystal L. Mackall, MD, Theodore W. Laetsch, MD, Liora M. Schultz, MD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 42–44.
Published: 2020
... those in these pivotal clinical trials. The Managed Access Program (MAP) provides access to tisagenlecleucel for patients with B-ALL or diffuse large B-cell lymphoma that is out of specification (OOS) for whom repeat leukapheresis is not feasible. Patients may also receive OOS tisagenlecleucel...
Journal Articles
David G. Maloney, MD PhD, John Kuruvilla, MD, Christopher P Fox, MD PhD, Guillaume Cartron, MD PhD, Daniel Li, PhD, Jens Hasskarl, MD, Ashley Bonner, PhD, Yixie Zhang, PhD, Fei Fei Liu, BSc, MBA
Journal:
Blood
Blood (2020) 136 (Supplement 1): 18–19.
Published: 2020
... in patients with R/R LBCL, yet no head-to-head clinical trials comparing options exist to date. We conducted 2 separate pair-wise MAICs to compare treatment effects of liso-cel vs both axi-cel and tisagenlecleucel. Methods: MAICs were used to estimate population-adjusted relative treatment effects associated...
Journal Articles
Liora M. Schultz, MD, Christina Baggott, RN, PhD, Snehit Prabhu, PhD, Holly Pacenta, MD, Christine L Phillips, MD, Jenna Rossoff, MD, Heather Stefanski, MDPhD, Julie-An Talano, MD, Amy Moskop, MD, Steven P. Margossian, MD PhD, Michael R Verneris, MD, Gary Douglas Myers, MD, Nicole Karras, MD, Patrick A. Brown, MD, Muna Qayed, MDMSc, Michelle Hermiston, MD PhD, Prakash Satwani, MD, Christa Krupski, DO, MPH, Amy Keating, MD, Rachel Wilcox, Cara A Rabik, MDPhD, Vanessa Fabrizio, MD, Michael Kunicki, Vasant Chinnabhandar, MD, A. Yasemin Goksenin, MD PhD MA, MPH, Kevin J. Curran, MD, Crystal L. Mackall, MD, Theodore W. Laetsch, MD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 14–15.
Published: 2020
.... Mackall, MD; Theodore W. Laetsch, MD Introduction: Chimeric Antigen Receptor (CAR) T cell therapy targeting CD19 has shifted our treatment approach for relapsed and refractory (r/r) pediatric B cell acute lymphoblastic leukemia (ALL). The landmark ELIANA pediatric trial studying tisagenlecleucel, CD19...
Journal Articles
Geoffrey Shouse, DO, PhD, Sylvia O Dulan, RN, Jamie Wagner, BS, Michelle Mott, RN, Alex Ly, Donna Ujiiye, Mary C. Clark, PhD, Kathie Viers, RN, Stephen J. Forman, MD, Eileen P. Smith, MD, David S Snyder, MD, Lihua E Budde, MD PhD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 10.
Published: 2020
... a retrospective analysis of electronically submitted SOC deviations for patients treated with commercially available chimeric antigen receptor (CAR) T cell products (tisagenlecleucel or axicabtagene ciloleucel [Axi-cel]) between December 2017- March 2020 at COH. Methods During the reporting timeframe, 122...
Journal Articles
Sara Ghorashian, FRCPath, PhD, Caroline Furness, Michelle Cummins, John A Snowden, BSc (Hons), MBChB, MD FRCP, FRCPath, Maeve A O'Reilly, MBBCHBAO, Claire Roddie, PhD MD, Lorna Neill, Emma Nicholson, Caroline Besley, MBBChir, MRCPath, MRCP, Sridhar Chaganti, MDPhDMRCP,FRCPath, John Gillson, MD, Antonio Pagliuca, MBBS, MA, FRCP, FRCPath, Anna Castleton, FRCPath, Amit Patel, MBBS,PhDFRCPath,MRCP, Peter Clark, MA MDFRCP, Robert Fernley, Robert Wynn, MD, Ajay Vora, MD, David I. Marks, MB, MS, FRACP, PhD FRCPath, Geoff Shenton, Persis J Amrolia, FRCP, FRCPath, PhD, Denise Bonney, Rachael E Hough, MD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 18–19.
Published: 2020
... Background: Tisagenlecleucel was approved in Europe for relapsed/refractory acute lymphoblastic leukemia (ALL) in young patients in 2018. In England, a national CAR T cell panel (NCCP ALL) ensures equity of access and assesses eligibility using inclusion and exclusion criteria based on the ELIANA study. All...
Journal Articles
Aimee C Talleur, MD, Renee M. Madden, MS, MD, Amr Qudeimat, MD, Ewelina Mamcarz, MD, Akshay Sharma, MBBS, Ashok Srinivasan, MD, Ali Y Suliman, MD, Mireya Paulina Velasquez, MD, Timothy Lockey, PhD, Alisha Gaboriault, Seth E. Karol, MD, Hiroto Inaba, MD PhD, Ying Li, MD PhD, Pam Young, Guolian Kang, PhD, Cheng Cheng, PhD, Wenting Zheng, PhD, Sheng Zhou, PhD, Salem M. Akel, PhD, Terrence L Geiger, MD PhD, Michael M Meagher, PhD, Ching-Hon Pui, MD, Brandon M Triplett, MD, Stephen Gottschalk, MD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 39–40.
Published: 2020
... be observed or proceed to consolidative allogeneic hematopoietic cell transplantation (HCT). To address this question, we reviewed the clinical course of all patients (n=22) who received either an investigational CAR T-cell product (Phase I study: SJCAR19 [NCT03573700]; n=12) or tisagenlecleucel (n=10) at our...
Journal Articles
Viktoria Blumenberg, MD, Maria-Luisa Schubert, MD, Eli Zamir, Sabine Schmidt, Roman Rohrbach, Philipp Waldhoff, Daria Bozic, Hendrik Pock, MD, Eran Elinav, Christian Schmidt, MD, Veit Buecklein, MD, Carsten Müller-Tidow, MD, Peter Dreger, MD, Michael von Bergwelt, MD PhD, Michael Schmitt, MD, Marion Subklewe, MD, Christoph Stein-Thöringer, MD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 33–34.
Published: 2020
...; Marion Subklewe, MD; Christoph Stein-Thöringer, MD Viktoria Blumenberg and Maria-Luisa Schubert contributed equally. Introduction: The CD19 specific chimeric antigen receptor (CAR) T-cell products Axicabtagene-Ciloleucel and Tisagenlecleucel are approved for the treatment of refractory/relapsed B-cell...
Journal Articles
Agne Taraseviciute, MD, Seth M. Steinberg, PhD, Regina M. Myers, MD, Lia Gore, MD, Adam J. Lamble, MD, Patrick A. Brown, MD, Jennifer Sheppard, Bonnie Yates, NP, Perry Chung, MD, Lee Chen, Colleen Annesley, MD, Deepa Bhojwani, MD, Theodore W. Laetsch, MD, Rebecca A Gardner, MD, Susan R. Rheingold, MD, Michael A Pulsipher, MD, Nirali N. Shah, MD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 13–14.
Published: 2020
... for increased relapse risk and/or CAR non-response due to selective pressure on CD19. The tisagenlecleucel registration trial in pediatric ALL excluded patients who had received prior blina. Thus, there is limited data regarding the impact of blina on long-term outcomes in patients receiving subsequent CD19 CAR...
Journal Articles
Chiara Monfrini, Vanessa Aragona, Martina Magni, Riccardo Betta, Cristina Vella, Chiara Paolizzi, Anna Dodero, Annalisa Chiappella, Anna Guidetti, Paolo Corradini, Cristiana Carniti
Journal:
Blood
Blood (2020) 136 (Supplement 1): 48–49.
Published: 2020
.../refractory lymphomas. High rates of complete remission (CR) observed in clinical trials, led to fast-track FDA and EMA approval and commercialization of two CD19-directed CAR T-cell products (tisagenlecleucel/Tisa-cel/Kymriah and axicabtagene ciloleucel/Axi-cel/Yescarta) for refractory/relapsed diffuse large...
Journal Articles
Ilaria M. Michelozzi, PhD, Eduardo Gomez-Castaneda, PhD, Ruben V.C. Pohle, Ferran Cardoso Rodriguez, Jahangir Sufi, Pau Puigdevall, PhD, Meera Subramaniyam, Si Wei Wu, Aleks Guvenel, PhD, Sara Ghorashian, FRCPath, PhD, Martin Pule, MDPhD, Christopher J. Tape, PhD, Sergi Castellano, PhD, Persis J Amrolia, FRCP, FRCPath, PhD, Alice Giustacchini, PhD
Journal:
Blood
Blood (2020) 136 (Supplement 1): 52–53.
Published: 2020
... affinity (FMC63 based) CAR used in Tisagenlecleucel in pre-clinical models. Furthermore, CAT CAR T cells showed an excellent toxicity profile, enhanced in vivo expansion and long-term persistence in a Phase I clinical study (Ghorashian et al Nature Med 2019). However the molecular mechanisms behind...
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