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1. Durable response after tisagenlecleucel in adults with relapsed/refractory follicular lymphoma: ELARA trial update

Author

Dreyling, Martin, Fowler, Nathan Hale, Dickinson, Michael, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason, Ghosh, Monalisa, Popplewell, Leslie, Chavez, Julio C., Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie José, Andreadis, Charalambos, Riedell, Peter A., Ho, P. Joy, Pérez-Simón, José Antonio, Chen, Andy I., Nastoupil, Loretta J., von Tresckow, Bastian, María Ferreri, Andrés José, Teshima, Takanori, Patten, Piers E. M., McGuirk, Joseph P., Petzer, Andreas L., Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Paule, Ines, Zia, Aiesha, Awasthi, Rakesh, Han, Xia, Germano, Davide, O’Donovan, Darragh, Ramos, Roberto, Maier, Harald J., Masood, Aisha, Thieblemont, Catherine, and Schuster, Stephen J.

Published
2024
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2. Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up

Author

Schuster, Stephen J., primary, Fowler, Nathan H., additional, Dickinson, Michael, additional, Martinez-Lopez, Joaquin, additional, Kolstad, Arne, additional, Butler, Jason, additional, Ghosh, Monalisa, additional, Popplewell, Leslie, additional, Chavez, Julio C., additional, Bachy, Emmanuel, additional, Kato, Koji, additional, Harigae, Hideo, additional, Kersten, Marie José, additional, Andreadis, Charalambos, additional, Riedell, Peter A., additional, Ho, P Joy, additional, Pérez-Simón, José Antonio, additional, Chen, Andy I., additional, Nastoupil, Loretta J., additional, von Tresckow, Bastian, additional, Ferreri, Andres Jose Maria, additional, Teshima, Takanori, additional, Patten, Piers EM, additional, McGuirk, Joseph P., additional, Petzer, Andreas, additional, Offner, Fritz, additional, Viardot, Andreas, additional, Zinzani, Pier Luigi, additional, Malladi, Ram, additional, Zia, Aiesha, additional, Awasthi, Rakesh, additional, Paule, Ines, additional, Germano, Davide, additional, Ramos, Roberto, additional, Hsu, Pei, additional, Thieblemont, Catherine, additional, and Dreyling, Martin, additional

Published
2024
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3. Long-Term Durable Responses in Patients with Relapsed/Refractory (R/R) Acute Lymphoblastic Leukemia (ALL), Diffuse Large B-Cell Lymphoma (DLBCL), and Follicular Lymphoma (FL) Treated with Tisagenlecleucel and Its Association with Persistence of Chimeric Antigen Receptor (CAR) T Cells

Author

Awasthi, Rakesh, primary, Waldron, Edward, additional, Grupp, Stephan A., additional, Pulsipher, Mike A., additional, Bader, Peter, additional, Schuster, Stephen J., additional, Maziarz, Richard T., additional, Waller, Edmund K., additional, Jager, Ulrich, additional, Thieblemont, Catherine, additional, Dreyling, Martin, additional, Fowler, Nathan H., additional, Maier, Harald Jakob, additional, and Willert, Jennifer, additional

Published
2024
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4. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial

Author

Fowler, Nathan Hale, Dickinson, Michael, Dreyling, Martin, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason, Ghosh, Monalisa, Popplewell, Leslie, Chavez, Julio C., Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie José, Andreadis, Charalambos, Riedell, Peter A., Ho, P. Joy, Pérez-Simón, José Antonio, Chen, Andy I., Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andrés José María, Teshima, Takanori, Patten, Piers E. M., McGuirk, Joseph P., Petzer, Andreas L., Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Zia, Aiesha, Awasthi, Rakesh, Masood, Aisha, Anak, Oezlem, Schuster, Stephen J., and Thieblemont, Catherine

Published
2022
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5. Tisagenlecleucel immunogenicity in relapsed/refractory acute lymphoblastic leukemia and diffuse large B-cell lymphoma

Author

Thudium Mueller, Karen, Grupp, Stephan A., Maude, Shannon L., Levine, John E., Pulsipher, Michael A., Boyer, Michael W., August, Keith J., Myers, G. Doug, Tam, Constantine S., Jaeger, Ulrich, Foley, Stephen Ronan, Borchmann, Peter, Schuster, Stephen J., Waller, Edmund K., Awasthi, Rakesh, Potthoff, Bernd, Warren, Andy, Waldron, Edward R., McBlane, Fraser, Chassot-Agostinho, Andrea, and Laetsch, Theodore W.

Published
2021
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7. Tisagenlecleucel cellular kinetics, dose, and immunogenicity in relation to clinical factors in relapsed/refractory DLBCL

Author

Awasthi, Rakesh, Pacaud, Lida, Waldron, Edward, Tam, Constantine S., Jäger, Ulrich, Borchmann, Peter, Jaglowski, Samantha, Foley, Stephen Ronan, van Besien, Koen, Wagner-Johnston, Nina D., Kersten, Marie José, Schuster, Stephen J., Salles, Gilles, Maziarz, Richard T., Anak, Özlem, del Corral, Christopher, Chu, Jufen, Gershgorin, Irina, Pruteanu-Malinici, Iulian, Chakraborty, Abhijit, Mueller, Karen Thudium, and Waller, Edmund K.

Published
2020
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8. POSTER: CT-564 ELARA Trial Update: Long-Term Clinical Outcomes and Correlative Efficacy Analyses of Tisagenlecleucel in Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL)

Author

Fowler, Nathan, primary, Dreyling, Martin, additional, Dickinson, Michael, additional, Martinez-Lopez, Joaquin, additional, Kolstad, Arne, additional, Butler, Jason, additional, Ghosh, Monalisa, additional, Popplewell, Leslie, additional, Chavez, Julio, additional, Bachy, Emmanuel, additional, Kato, Koji, additional, Harigae, Hideo, additional, Kersten, Marie José, additional, Andreadis, Charalambos, additional, Riedell, Peter, additional, Ho, P. Joy, additional, Pérez-Simón, José Antonio, additional, Chen, Andy, additional, Nastoupil, Loretta, additional, Tresckow, Bastian von, additional, Ferreri, Andrés José María, additional, Teshima, Takanori, additional, Patten, Piers, additional, McGuirk, Joseph, additional, Petzer, Andreas, additional, Offner, Fritz, additional, Viardot, Andreas, additional, Zinzani, Pier, additional, Malladi, Ram, additional, Paule, Ines, additional, Zia, Aiesha, additional, Awasthi, Rakesh, additional, Han, Xia, additional, Germano, Davide, additional, O'Donovan, Darragh, additional, Ramos, Roberto, additional, Masood, Aisha, additional, Thieblemont, Catherine, additional, and Schuster, Stephen, additional

Published
2023
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9. CT-564 ELARA Trial Update: Long-Term Clinical Outcomes and Correlative Efficacy Analyses of Tisagenlecleucel in Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL)

Author

Fowler, Nathan, primary, Dreyling, Martin, additional, Dickinson, Michael, additional, Martinez-Lopez, Joaquin, additional, Kolstad, Arne, additional, Butler, Jason, additional, Ghosh, Monalisa, additional, Popplewell, Leslie, additional, Chavez, Julio, additional, Bachy, Emmanuel, additional, Kato, Koji, additional, Harigae, Hideo, additional, Kersten, Marie José, additional, Andreadis, Charalambos, additional, Riedell, Peter, additional, Ho, P. Joy, additional, Pérez-Simón, José Antonio, additional, Chen, Andy, additional, Nastoupil, Loretta, additional, Tresckow, Bastian von, additional, Ferreri, Andrés José María, additional, Teshima, Takanori, additional, Patten, Piers, additional, McGuirk, Joseph, additional, Petzer, Andreas, additional, Offner, Fritz, additional, Viardot, Andreas, additional, Zinzani, Pier, additional, Malladi, Ram, additional, Paule, Ines, additional, Zia, Aiesha, additional, Awasthi, Rakesh, additional, Han, Xia, additional, Germano, Davide, additional, O'Donovan, Darragh, additional, Ramos, Roberto, additional, Masood, Aisha, additional, Thieblemont, Catherine, additional, and Schuster, Stephen, additional

Published
2023
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13. Supplementary Data from Clinical Pharmacology of Tisagenlecleucel in B-cell Acute Lymphoblastic Leukemia

Author

Mueller, Karen Thudium, primary, Waldron, Edward, primary, Grupp, Stephan A., primary, Levine, John E., primary, Laetsch, Theodore W., primary, Pulsipher, Michael A., primary, Boyer, Michael W., primary, August, Keith J., primary, Hamilton, Jason, primary, Awasthi, Rakesh, primary, Stein, Andrew M., primary, Sickert, Denise, primary, Chakraborty, Abhijit, primary, Levine, Bruce L., primary, June, Carl H., primary, Tomassian, Lori, primary, Shah, Sweta S., primary, Leung, Mimi, primary, Taran, Tetiana, primary, Wood, Patricia A., primary, and Maude, Shannon L., primary

Published
2023
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15. Long-Term Clinical Outcomes and Correlative Efficacy Analyses in Patients (Pts) with Relapsed/Refractory Follicular Lymphoma (r/r FL) Treated with Tisagenlecleucel in the Elara Trial

Author

Dreyling, Martin, primary, Dickinson, Michael, additional, Martinez Lopez, Joaquin, additional, Kolstad, Arne, additional, Butler, Jason P, additional, Ghosh, Monalisa, additional, Popplewell, Leslie L., additional, Chavez, Julio, additional, Bachy, Emmanuel, additional, Kato, Koji, additional, Harigae, Hideo, additional, Kersten, Marie Jose, additional, Andreadis, Charalambos, additional, Riedell, Peter A., additional, Ho, Phoebe Joy, additional, Perez-Simon, Jose A., additional, Chen, Andy, additional, Nastoupil, Loretta J., additional, von Tresckow, Bastian, additional, Ferreri, Andrés J M, additional, Teshima, Takanori, additional, Patten, Piers E.M., additional, McGuirk, Joseph P., additional, Petzer, Andreas, additional, Offner, Fritz, additional, Viardot, Andreas, additional, Zinzani, Pier Luigi, additional, Malladi, Ram, additional, Paule, Ines, additional, Zia, Aiesha, additional, Awasthi, Rakesh, additional, Han, Xia, additional, Germano, Davide, additional, O'Donovan, Darragh, additional, Ramos, Roberto, additional, Masood, Aisha, additional, Thieblemont, Catherine, additional, Fowler, Nathan H., additional, and Schuster, Stephen J., additional

Published
2022
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16. Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma

Author

Bishop, Michael R., primary, Dickinson, Michael, additional, Purtill, Duncan, additional, Barba, Pere, additional, Santoro, Armando, additional, Hamad, Nada, additional, Kato, Koji, additional, Sureda, Anna, additional, Greil, Richard, additional, Thieblemont, Catherine, additional, Morschhauser, Franck, additional, Janz, Martin, additional, Flinn, Ian, additional, Rabitsch, Werner, additional, Kwong, Yok-Lam, additional, Kersten, Marie J., additional, Minnema, Monique C., additional, Holte, Harald, additional, Chan, Esther H.L., additional, Martinez-Lopez, Joaquin, additional, Müller, Antonia M.S., additional, Maziarz, Richard T., additional, McGuirk, Joseph P., additional, Bachy, Emmanuel, additional, Le Gouill, Steven, additional, Dreyling, Martin, additional, Harigae, Hideo, additional, Bond, David, additional, Andreadis, Charalambos, additional, McSweeney, Peter, additional, Kharfan-Dabaja, Mohamed, additional, Newsome, Simon, additional, Degtyarev, Evgeny, additional, Awasthi, Rakesh, additional, del Corral, Christopher, additional, Andreola, Giovanna, additional, Masood, Aisha, additional, Schuster, Stephen J., additional, Jäger, Ulrich, additional, Borchmann, Peter, additional, and Westin, Jason R., additional

Published
2022
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17. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial

Author

Fowler, Nathan Hale, primary, Dickinson, Michael, additional, Dreyling, Martin, additional, Martinez-Lopez, Joaquin, additional, Kolstad, Arne, additional, Butler, Jason, additional, Ghosh, Monalisa, additional, Popplewell, Leslie, additional, Chavez, Julio C., additional, Bachy, Emmanuel, additional, Kato, Koji, additional, Harigae, Hideo, additional, Kersten, Marie José, additional, Andreadis, Charalambos, additional, Riedell, Peter A., additional, Ho, P. Joy, additional, Pérez-Simón, José Antonio, additional, Chen, Andy I., additional, Nastoupil, Loretta J., additional, von Tresckow, Bastian, additional, Ferreri, Andrés José María, additional, Teshima, Takanori, additional, Patten, Piers E. M., additional, McGuirk, Joseph P., additional, Petzer, Andreas L., additional, Offner, Fritz, additional, Viardot, Andreas, additional, Zinzani, Pier Luigi, additional, Malladi, Ram, additional, Zia, Aiesha, additional, Awasthi, Rakesh, additional, Masood, Aisha, additional, Anak, Oezlem, additional, Schuster, Stephen J., additional, and Thieblemont, Catherine, additional

Published
2021
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18. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma

Author

Schuster, Stephen J., Bishop, Michael R., Tam, Constantine S., Waller, Edmund K., Borchmann, Peter, McGuirk, Joseph P., Jäger, Ulrich, Jaglowski, Samantha, Andreadis, Charalambos, Westin, Jason R., Fleury, Isabelle, Bachanova, Veronika, Foley, S. Ronan, Ho, P. Joy, Mielke, Stephan, Magenau, John M., Holte, Harald, Pantano, Serafino, Pacaud, Lida B., Awasthi, Rakesh, Chu, Jufen, Anak, Özlem, Salles, Gilles, Maziarz, Richard T., Study group members AMC, Kersten, Marie José J., Biemond, Bart J., Burger, Patrick, Claessen, Marie-José J. A. G., Hazenberg, Mette D., Kater, Arnon P., Kemper, E. M., Nur, Erfan, Spiering, Marjolein, Tonino, Sanne H., Voermans, Carlijn, Zeerleder, Sacha S., CCA - Cancer biology and immunology, Clinical Haematology, CCA - Cancer Treatment and Quality of Life, AII - Inflammatory diseases, Experimental Immunology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Pharmacy, Landsteiner Laboratory, ACS - Pulmonary hypertension & thrombosis, and ACS - Atherosclerosis & ischemic syndromes

Subjects
Oncology, medicine.medical_specialty, Chemotherapy, business.industry, medicine.medical_treatment, General Medicine, 030204 cardiovascular system & hematology, medicine.disease, Polatuzumab vedotin, Lymphoma, Transplantation, 03 medical and health sciences, 0302 clinical medicine, Refractory, Internal medicine, Medicine, Refractory Diffuse Large B-Cell Lymphoma, Chimeric Antigen Receptor T-Cell Therapy, 030212 general & internal medicine, Progression-free survival, business
Abstract

Background: Patients with diffuse large B-cell lymphoma that is refractory to primary and secondline therapies or that has relapsed after stem-cell transplantation have a poor prognosis. The chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel targets and eliminates CD19-expressing B cells and showed efficacy against B-cell lymphomas in a single-center, phase 2a study. Methods: We conducted an international, phase 2, pivotal study of centrally manufactured tisagenlecleucel involving adult patients with relapsed or refractory diffuse large B-cell lymphoma who were ineligible for or had disease progression after autologous hematopoietic stem-cell transplantation. The primary end point was the best overall response rate (i.e., the percentage of patients who had a complete or partial response), as judged by an independent review committee. Results: A total of 93 patients received an infusion and were included in the evaluation of efficacy. The median time from infusion to data cutoff was 14 months (range, 0.1 to 26). The best overall response rate was 52% (95% confidence interval, 41 to 62); 40% of the patients had complete responses, and 12% had partial responses. Response rates were consistent across prognostic subgroups. At 12 months after the initial response, the rate of relapse-free survival was estimated to be 65% (79% among patients with a complete response). The most common grade 3 or 4 adverse events of special interest included cytokine release syndrome (22%), neurologic events (12%), cytopenias lasting more than 28 days (32%), infections (20%), and febrile neutropenia (14%). Three patients died from disease progression within 30 days after infusion. No deaths were attributed to tisagenlecleucel, cytokine release syndrome, or cerebral edema. No differences between response groups in tumor expression of CD19 or immune checkpoint- related proteins were found. Conclusions: In this international study of CAR T-cell therapy in relapsed or refractory diffuse large B-cell lymphoma in adults, high rates of durable responses were produced with the use of tisagenlecleucel.

Published
2019

19. Ibrutinib before Apheresis May Improve Tisagenlecleucel Manufacturing in Relapsed/Refractory Adult Diffuse Large B-Cell Lymphoma: Initial Results from a Phase 1b Study

Author

Chavez, Julio C., primary, Locke, Frederick L., additional, Napier, Ellen, additional, Simon, Carl, additional, Lewandowski, Andrew, additional, Awasthi, Rakesh, additional, Engels, Boris, additional, Georgala, Petrina, additional, Bondanza, Attilio, additional, and Schuster, Stephen J., additional

Published
2020
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20. Bianca: Phase II, single-arm, global trial to determine efficacy and safety of tisagenlecleucel in pediatric/young adult (YA) patients (Pts) with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).

Author

Minard, Veronique, primary, Maude, Shannon L., additional, Buechner, Jochen, additional, Krueger, Joerg, additional, Locatelli, Franco, additional, Attarbaschi, Andishe, additional, Laetsch, Theodore Willis, additional, González Martínez, Berta, additional, Diaz de Heredia Rubio, Cristina, additional, Awasthi, Rakesh, additional, Newsome, Simon, additional, Davis, Jaclyn, additional, Bubuteishvili-Pacaud, Lida, additional, and Burkhardt, Birgit, additional

Published
2020
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21. Correlation of Bridging and Lymphodepleting Chemotherapy with Clinical Outcomes in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated with Tisagenlecleucel

Author

Andreadis, Charalambos, primary, Tam, Constantine S., additional, Borchmann, Peter, additional, Jaeger, Ulrich, additional, McGuirk, Joseph P., additional, Holte, Harald, additional, Waller, Edmund K., additional, Jaglowski, Samantha, additional, Bishop, Michael R., additional, Foley, Stephen Ronan, additional, Westin, Jason R., additional, Fleury, Isabelle, additional, Ho, P Joy, additional, Mielke, Stephan, additional, Teshima, Takanori, additional, Salles, Gilles A., additional, Schuster, Stephen J, additional, Bachanova, Veronika, additional, Maziarz, Richard T., additional, Van Besien, Koen, additional, Izutsu, Koji, additional, Magenau, John M., additional, Wagner-Johnston, Nina D., additional, Kato, Koji, additional, Corradini, Paolo, additional, Tiwari, Ranjan, additional, Awasthi, Rakesh, additional, Lawniczek, Tomasz, additional, Eldjerou, Lamis K., additional, and Kersten, Marie Jose, additional

Published
2019
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22. Tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma patients without measurable disease at infusion

Author

Bishop, Michael R., primary, Maziarz, Richard T., additional, Waller, Edmund K., additional, Jäger, Ulrich, additional, Westin, Jason R., additional, McGuirk, Joseph P., additional, Fleury, Isabelle, additional, Holte, Harald, additional, Borchmann, Peter, additional, del Corral, Christopher, additional, Tiwari, Ranjan, additional, Anak, Özlem, additional, Awasthi, Rakesh, additional, Pacaud, Lida, additional, Romanov, Vadim V., additional, and Schuster, Stephen J., additional

Published
2019
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23. Abstract CT237: Evaluation of in vivo chimeric antigen receptor (CAR) transgene levels in patients (pts) treated with tisagenlecleucel

Author

Awasthi, Rakesh, primary, Mueller, Karen Thudium, additional, Yanik, Gregory A., additional, Tam, Constantine S., additional, Rives, Susana, additional, McGuirk, Joseph P., additional, Pulsipher, Michael A., additional, Boyer, Michael W., additional, Jaeger, Ulrich, additional, Baruchel, Andre, additional, Myers, Gary D., additional, Borchmann, Peter, additional, Schuster, Stephen J., additional, Stefanski, Heather, additional, Bishop, Michael, additional, Waldron, Edward R., additional, Anak, Ozlem, additional, Chakraborty, Abhijit, additional, Bleickardt, Eric, additional, Wong, Stephane, additional, Pacaud, Lida Bubuteishvili, additional, Waller, Edmund K., additional, and Maude, Shannon L., additional

Published
2019
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24. Tisagenlecleucel Model‐Based Cellular Kinetic Analysis of Chimeric Antigen Receptor–T Cells

Author

Stein, Andrew M., primary, Grupp, Stephan A., additional, Levine, John E., additional, Laetsch, Theodore W., additional, Pulsipher, Michael A., additional, Boyer, Michael W., additional, August, Keith J., additional, Levine, Bruce L., additional, Tomassian, Lori, additional, Shah, Sweta, additional, Leung, Mimi, additional, Huang, Pai‐Hsi, additional, Awasthi, Rakesh, additional, Mueller, Karen Thudium, additional, Wood, Patricia A., additional, and June, Carl H., additional

Published
2019
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25. Clinical Pharmacology of Tisagenlecleucel in B-cell Acute Lymphoblastic Leukemia

Author

Mueller, Karen Thudium, primary, Waldron, Edward, additional, Grupp, Stephan A., additional, Levine, John E., additional, Laetsch, Theodore W., additional, Pulsipher, Michael A., additional, Boyer, Michael W., additional, August, Keith J., additional, Hamilton, Jason, additional, Awasthi, Rakesh, additional, Stein, Andrew M., additional, Sickert, Denise, additional, Chakraborty, Abhijit, additional, Levine, Bruce L., additional, June, Carl H., additional, Tomassian, Lori, additional, Shah, Sweta S., additional, Leung, Mimi, additional, Taran, Tetiana, additional, Wood, Patricia A., additional, and Maude, Shannon L., additional

Published
2018
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26. Evaluation of In Vivo CAR Transgene Levels in Relapsed/Refractory Pediatric and Young Adult ALL and Adult DLBCL Tisagenlecleucel-Treated Patients

Author

Awasthi, Rakesh, primary, Mueller, Karen Thudium, additional, Yanik, Gregory A., additional, Tam, Constantine S., additional, Rives, Susana, additional, McGuirk, Joseph P., additional, Pulsipher, Michael A., additional, Boyer, Michael W., additional, Jaeger, Ulrich, additional, Baruchel, Andre, additional, Myers, Gary Douglas, additional, Balke-Want, Hyatt, additional, Schuster, Stephen J., additional, Stefanski, Heather, additional, Bishop, Michael R., additional, Waldron, Edward R., additional, Anak, Özlem, additional, Chakraborty, Abhijit, additional, Bleickardt, Eric, additional, Wong, Stephane, additional, Bubuteishvili Pacaud, Lida, additional, Waller, Edmund K., additional, and Maude, Shannon L., additional

Published
2018
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27. Safety and Efficacy of Tisagenlecleucel Treatment in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) and No Evidence of Active Disease Following Bridging Chemotherapy in the JULIET Trial

Author

Bishop, Michael R., primary, Maziarz, Richard Thomas T., additional, Waller, Edmund K., additional, del Corral, Christopher, additional, Tiwari, Ranjan, additional, Anak, Özlem, additional, Awasthi, Rakesh, additional, Romanov, Vadim V., additional, and Schuster, Stephen J., additional

Published
2018
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28. Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up

Author

Schuster, Stephen J, Fowler, Nathan, Dickinson, Michael, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason, Ghosh, Monalisa, Popplewell, Leslie L., Chavez, Julio C, Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie José, Andreadis, Charalambos, Riedell, Peter A, Ho, Phoebe Joy, Perez-Simon, Jose A., Chen, Andy, Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andrés José María, Teshima, Takanori, Patten, Piers, McGuirk, Joseph P, Petzer, Andreas L, Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Zia, Aiesha, Awasthi, Rakesh, Paule, Ines, Germano, Davide, Ramos, Roberto Javier, Hsu, Pei, Thieblemont, Catherine, and Dreyling, Martin

Abstract

Background: Tisagenlecleucel is approved in the United States and Europe for adults with relapsed/refractory follicular lymphoma (r/r FL) after ≥2 lines of prior therapy. The primary analysis of the Phase II ELARA trial (median follow-up: 17 months) reported high response rates and a favorable safety profile in heavily pretreated patients with r/r FL. Here we report longer-term efficacy, safety, pharmacokinetic, and exploratory biomarker analyses after a median follow-up of more than 3 years.

Published
2023
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29. Long Term Durable Responses in Relapsed/Refractory (r/r) ALL, DLBCL, and FL Patients Treated with Tisagenlecleucel and Its Association with Persistence of CAR T-Cells

Author

Awasthi, Rakesh, Waldron, Edward, Grupp, Stephan, Pulsipher, Michael A., Bader, Peter, Schuster, Stephen J, Maziarz, Richard T, Waller, Edmund K., Jaeger, Ulrich, Thieblemont, Catherine, Dreyling, Martin, Fowler, Nathan, Maier, Harald Jakob, and Willert, Jennifer

Abstract

Introduction:Monitoring of chimeric antigen receptor (CAR) transgene levels in peripheral blood post tisagenlecleucel (tisa-cel) infusion provides information on expansion and persistence of CAR T-cells. In adult diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL) patients (pts), the expansion of CAR T-cells was similar between responding and non-responding pts, while in pediatric and young adult acute lymphoblastic leukemia (ALL) pts, higher expansion in responding pts was observed. Based on long term follow up data from tisa-cel treated pts, analyses were performed to delineate the impact of CAR persistence and B cell aplasia on duration of remission (DOR).

Published
2023
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30. Abstract CT110: Clinical pharmacology of tisagenlecleucel (CTL019) in patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL)

Author

Awasthi, Rakesh, primary, Tam, Constantine S., additional, Jaeger, Ulrich, additional, Jaglowski, Samantha, additional, Foley, Stephen Ronan, additional, Besien, Koen van, additional, Wagner-Johnston, Nina D., additional, Kersten, Maria José, additional, Schuster, Stephen J., additional, Salles, Gilles, additional, Maziarz, Richard T., additional, Anak, Özlem, additional, Pacaud, Lida Bubuteishvili, additional, Gazi, Lucien, additional, Waldron, Edward, additional, Hamilton, Jason, additional, Pruteanu, Iulian, additional, Tai, Feng, additional, Mueller, Karen Thudium, additional, and Waller, Edmund K., additional

Published
2018
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31. Immunogenicity of tisagenlecleucel in relapsed/ refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) and diffuse large B-cell lymphoma (DLBCL) patients.

Author

Mueller, Karen Thudium, primary, Grupp, Stephan A., additional, Maude, Shannon L., additional, Levine, John E., additional, Pulsipher, Michael, additional, Boyer, Michael W., additional, August, Keith Jason, additional, Myers, Gary Douglas, additional, Awasthi, Rakesh, additional, Waldron, Edward K, additional, Bubuteishvili-Pacaud, Lida, additional, Taran, Tanya, additional, Cota, Mariana, additional, Tam, Constantine Si Lun, additional, Jäger, Ulrich, additional, Foley, Ronan, additional, Borchmann, Peter, additional, Schuster, Stephen J., additional, Waller, Edmund K., additional, and Laetsch, Theodore Willis, additional

Published
2018
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32. Considerations for tisagenlecleucel dosing rationale.

Author

Awasthi, Rakesh, primary, Mueller, Karen Thudium, additional, Yanik, Gregory A., additional, Tam, Constantine Si Lun, additional, Rives, Susana, additional, McGuirk, Joseph, additional, Boyer, Michael W., additional, Jäger, Ulrich, additional, Baruchel, Andre, additional, Myers, Gary Douglas, additional, Borchmann, Peter, additional, Jaglowski, Samantha Mary, additional, Stefanski, Heather E, additional, Bishop, Michael Russell, additional, Waldron, Edward K, additional, Hamilton, Jason, additional, Cota, Mariana, additional, Bubuteishvili-Pacaud, Lida, additional, and Waller, Edmund K., additional

Published
2018
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33. Global Pivotal Phase 2 Trial of the CD19-Targeted Therapy CTL019 In Adult Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)—An Interim Analysis

Author

Schuster, Stephen, primary, Bishop, Michael R., additional, Tam, Constantine, additional, Waller, Edmund K., additional, Borchmann, Peter, additional, McGuirk, Joseph, additional, Jäger, Ulrich, additional, Jaglowski, Samantha, additional, Andreadis, Charalambos, additional, Westin, Jason, additional, Fleury, Isabelle, additional, Bachanova, Veronika, additional, Foley, Stephen Ronan, additional, Ho, P. Joy, additional, Mielke, Stephan, additional, Magenau, John M., additional, Holte, Harald, additional, Anak, Oezlem, additional, Pacaud, Lida, additional, Awasthi, Rakesh, additional, Tai, Feng, additional, Salles, Gilles, additional, and Maziarz, Richard T., additional

Published
2017
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34. CTL019 Clinical Pharmacology and Biopharmaceutics in Pediatric Patients with Relapsed or Refractory (R/R) Acute Lymphoblastic Leukemia (ALL)

Author

Mueller, Karen Thudium, primary, Waldron, Edward, additional, Grupp, Stephan A., additional, Levine, John, additional, Laetsch, Theodore W., additional, Pulsipher, Michael A., additional, Boyer, Michael, additional, August, Keith, additional, Hamilton, Jason, additional, Awasthi, Rakesh, additional, Sickert, Denise, additional, Chakraborty, Abhijit, additional, Levine, Bruce L., additional, June, Carl H., additional, Tomassian, Lori, additional, Leung, Mimi, additional, Taran, Tetiana, additional, Wood, Patricia, additional, and Maude, Shannon, additional

Published
2017
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35. Cellular Kinetics of Chimeric Antigen Receptor T Cells (CTL019) in Patients with Relapsed/Refractory CD19+ Leukemia

Author

Mueller, Karen Thudium, primary, Chakraborty, Abhijit, additional, Wood, Patricia A, additional, Awasthi, Rakesh, additional, Quintas-Cardama, Alfonso, additional, Han, Xia, additional, Maude, Shannon L, additional, Grupp, Stephan A., additional, Porter, David L, additional, Frey, Noelle, additional, Marcucci, Katherine T., additional, Levine, Bruce L, additional, Melenhorst, Jan J., additional, June, Carl H, additional, and Lacey, Simon F., additional

Published
2016
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36. CTL019 Model-Based Cellular Kinetic Analysis of Chimeric Antigen Receptor (CAR) T Cells to Characterize the Impact of Tocilizumab on Expansion and to Identify Correlates of Cytokine Release Syndrome Severity

Author

Stein, Andrew M, Grupp, Stephan A, Levine, John E, Laetsch, Theodore W, Pulsipher, Michael A, Boyer, Michael W, August, Keith J, Levine, Bruce L, June, Carl H, Tomassian, Lori, Shah, Sweta, Leung, Mimi, Huang, Pai-Hsi, Jolivet, Sebastien, Awasthi, Rakesh, Mueller, Karen Thudium, Wood, Patricia A, and Maude, Shannon L

Published
2017
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37. Pharmacokinetics and Pharmacodynamics of Tocilizumab for the Management of Cytokine Release Syndrome (CRS) in Pediatric and Young Adult Patients with Relapsed/Refractory (R/R) B-Cell Acute Lymphoblastic Leukemia (B-ALL) Treated with CAR T-Cell Therapy, CTL019

Author

Lee, Clarice, Bittencourt, Henrique, Rives, Susana, Boyer, Michael W, Pulsipher, Michael A, Verneris, Michael R, Yanik, Gregory, Jaitner, Birgit, Yi, Lan, Lund, Kathryn, Leung, Mimi, Awasthi, Rakesh, Wood, Patricia A, Maude, Shannon L, Grupp, Stephan A, and Mueller, Karen Thudium

Published
2017
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40. Primary Analysis of Juliet: A Global, Pivotal, Phase 2 Trial of CTL019 in Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Author

Schuster, Stephen J., Bishop, Michael R., Tam, Constantine S., Waller, Edmund K., Borchmann, Peter, McGuirk, Joseph P., Jaeger, Ulrich, Jaglowski, Samantha, Andreadis, Charalambos, Westin, Jason R., Fleury, Isabelle, Bachanova, Veronika, Foley, Stephen Ronan, Ho, P. Joy, Mielke, Stephan, Magenau, John M., Holte, Harald, Van Besien, Koen, Kersten, Marie Jose, Teshima, Takanori, Tobinai, Kensei, Corradini, Paolo, Anak, Oezlem, Bubuteishvili Pacaud, Lida, del Corral, Christopher, Awasthi, Rakesh, Tai, Feng, Salles, Gilles, and Maziarz, Richard Thomas

Published
2017
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42. Clinical Pharmacology of CTL019 in Patients with Relapsed/Refractory (r/r) Diffuse Large B-Cell Lymphoma (DLBCL)

Author

Awasthi, Rakesh, Tam, Constantine S., Jaeger, Ulrich, Jaglowski, Samantha, Foley, Stephen Ronan, Van Besien, Koen, Wagner-Johnston, Nina D., Kersten, Marie Jose, Schuster, Stephen J., Salles, Gilles Andre, Maziarz, Richard Thomas, Anak, Oezlem, Bubuteishvili Pacaud, Lida, Gazi, Lucien, Waldron, Edward, Hamilton, Jason, Pruteanu, Iulian, Tai, Feng, Mueller, Karen Thudium, and Waller, Edmund K.

Abstract

Background:CTL019 (tisagenlecleucel) is an adoptive cellular immunotherapy that uses the autologous peripheral blood T cells that have been genetically modified ex vivoto target CD19 on the surface of B cells. To date, little is known about the effect of cellular kinetics on clinical response, dose-response, and safety of CTL019 in DLBCL patients.

Published
2017
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43. Cellular kinetics of CTL019 in relapsed/refractory B-cell acute lymphoblastic leukemia and chronic lymphocytic leukemia.

Author

Thudium Mueller, Karen, Maude, Shannon L., Porter, David L., Frey, Noelle, Wood, Patricia, Han, Xia, Waldron, Edward, Chakraborty, Abhijit, Awasthi, Rakesh, Levine, Bruce L., Melenhorst, J. Joseph, Grupp, Stephan A., June, Carl H., and Lacey, Simon F.

Subjects
*LYMPHOBLASTIC leukemia, *LYMPHOCYTIC leukemia, *IMMUNOTHERAPY, *ANTIGEN receptors, *BONE marrow, *FLOW cytometry
Abstract

Tisagenlecleucel (CTL019) is an investigational immunotherapy that involves reprogramming a patient's own T cells with a transgene encoding a chimeric antigen receptor to identify and eliminate CD19-expressing cells. We previously reported that CTL019 achieved impressive clinical efficacy in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL), including the expansion and persistence of CTL019 cells, which correlates with response to therapy. Here, we performed formal cellular kinetic analyses of CTL019 in a larger cohort of 103 patients treated with CTL019 in 2 different diseases (ALL and CLL). CTL019 was measured in peripheral blood and bone marrow, using quantitative polymerase chain reaction and flow cytometry. CTL019 levels in peripheral blood typically peaked at 10 to 14 days postinfusion and then declined slowly over time. Patients with complete response (CR)/CR with incomplete count recovery had higher levels of CTL019 in peripheral blood, with greater maximal concentration and area under the curve values compared with nonresponding patients (P < .0001 for each). CTL019 transgene levels were measurable up to 780 days in peripheral blood. CTL019 trafficking and persistence were observed in bone marrow and cerebrospinal fluid. CTL019 expansion correlated with severity of cytokine release syndrome (CRS) and preinfusion tumor burden in pediatric ALL. The results described here are the first detailed formal presentation of cellular kinetics across 2 diseases and highlight the importance of the application of in vivo cellular kinetic analyses to characterize clinical efficacy and CRS severity associated with CTL019 therapy. [ABSTRACT FROM AUTHOR]

Published
2017
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