Long-term clinical outcomes of tisagenlecleucel in patients with relapsed or refractory aggressive B-cell lymphomas (JULIET): a multicentre, open-label, single-arm, phase 2 study
In the primary analysis of the pivotal JULIET trial of tisagenlecleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, the best overall response rate was 52% and the complete response rate was 40% in 93 evaluable adult patients with relapsed or refractory aggressive B-cell...
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| Vydané v: | The lancet oncology Ročník 22; číslo 10; s. 1403 - 1415 |
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| Hlavní autori: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
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London
Elsevier Ltd
01.10.2021
Elsevier Limited |
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| ISSN: | 1470-2045, 1474-5488, 1474-5488 |
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| Abstract | In the primary analysis of the pivotal JULIET trial of tisagenlecleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, the best overall response rate was 52% and the complete response rate was 40% in 93 evaluable adult patients with relapsed or refractory aggressive B-cell lymphomas. We aimed to do a long-term follow-up analysis of the clinical outcomes and correlative analyses of activity and safety in the full adult cohort.
In this multicentre, open-label, single-arm, phase 2 trial (JULIET) done at 27 treatment sites in ten countries (Australia, Austria, Canada, France, Germany, Italy, Japan, the Netherlands, Norway, and the USA), adult patients (≥18 years) with histologically confirmed relapsed or refractory large B-cell lymphomas who were ineligible for, did not consent to, or had disease progression after autologous haematopoietic stem-cell transplantation, with an Eastern Cooperative Oncology Group performance status of 0–1 at screening, were enrolled. Patients received a single intravenous infusion of tisagenlecleucel (target dose 5 × 108 viable transduced CAR T cells). The primary endpoint was overall response rate (ie, the proportion of patients with a best overall disease response of a complete response or partial response using the Lugano classification, as assessed by an independent review committee) at any time post-infusion and was analysed in all patients who received tisagenlecleucel (the full analysis set). Safety was analysed in all patients who received tisagenlecleucel. JULIET is registered with ClinialTrials.gov, NCT02445248, and is ongoing.
Between July 29, 2015, and Nov 2, 2017, 167 patients were enrolled. As of Feb 20, 2020, 115 patients had received tisagenlecleucel infusion and were included in the full analysis set. At a median follow-up of 40·3 months (IQR 37·8–43·8), the overall response rate was 53·0% (95% CI 43·5–62·4; 61 of 115 patients), with 45 (39%) patients having a complete response as their best overall response. The most common grade 3–4 adverse events were anaemia (45 [39%]), decreased neutrophil count (39 [34%]), decreased white blood cell count (37 [32%]), decreased platelet count (32 [28%]), cytokine release syndrome (26 [23%]), neutropenia (23 [20%]), febrile neutropenia (19 [17%]), hypophosphataemia (15 [13%]), and thrombocytopenia (14 [12%]). The most common treatment-related serious adverse events were cytokine release syndrome (31 [27%]), febrile neutropenia (seven [6%]), pyrexia (six [5%]), pancytopenia (three [3%]), and pneumonia (three [3%]). No treatment-related deaths were reported.
Tisagenlecleucel shows durable activity and manageable safety profiles in adult patients with relapsed or refractory aggressive B-cell lymphomas. For patients with large B-cell lymphomas that are refractory to chemoimmunotherapy or relapsing after second-line therapies, tisagenlecleucel compares favourably with respect to risk–benefit relative to conventional therapeutic approaches (eg, salvage chemotherapy).
Novartis Pharmaceuticals. |
|---|---|
| AbstractList | In the primary analysis of the pivotal JULIET trial of tisagenlecleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, the best overall response rate was 52% and the complete response rate was 40% in 93 evaluable adult patients with relapsed or refractory aggressive B-cell lymphomas. We aimed to do a long-term follow-up analysis of the clinical outcomes and correlative analyses of activity and safety in the full adult cohort.
In this multicentre, open-label, single-arm, phase 2 trial (JULIET) done at 27 treatment sites in ten countries (Australia, Austria, Canada, France, Germany, Italy, Japan, the Netherlands, Norway, and the USA), adult patients (≥18 years) with histologically confirmed relapsed or refractory large B-cell lymphomas who were ineligible for, did not consent to, or had disease progression after autologous haematopoietic stem-cell transplantation, with an Eastern Cooperative Oncology Group performance status of 0–1 at screening, were enrolled. Patients received a single intravenous infusion of tisagenlecleucel (target dose 5 × 108 viable transduced CAR T cells). The primary endpoint was overall response rate (ie, the proportion of patients with a best overall disease response of a complete response or partial response using the Lugano classification, as assessed by an independent review committee) at any time post-infusion and was analysed in all patients who received tisagenlecleucel (the full analysis set). Safety was analysed in all patients who received tisagenlecleucel. JULIET is registered with ClinialTrials.gov, NCT02445248, and is ongoing.
Between July 29, 2015, and Nov 2, 2017, 167 patients were enrolled. As of Feb 20, 2020, 115 patients had received tisagenlecleucel infusion and were included in the full analysis set. At a median follow-up of 40·3 months (IQR 37·8–43·8), the overall response rate was 53·0% (95% CI 43·5–62·4; 61 of 115 patients), with 45 (39%) patients having a complete response as their best overall response. The most common grade 3–4 adverse events were anaemia (45 [39%]), decreased neutrophil count (39 [34%]), decreased white blood cell count (37 [32%]), decreased platelet count (32 [28%]), cytokine release syndrome (26 [23%]), neutropenia (23 [20%]), febrile neutropenia (19 [17%]), hypophosphataemia (15 [13%]), and thrombocytopenia (14 [12%]). The most common treatment-related serious adverse events were cytokine release syndrome (31 [27%]), febrile neutropenia (seven [6%]), pyrexia (six [5%]), pancytopenia (three [3%]), and pneumonia (three [3%]). No treatment-related deaths were reported.
Tisagenlecleucel shows durable activity and manageable safety profiles in adult patients with relapsed or refractory aggressive B-cell lymphomas. For patients with large B-cell lymphomas that are refractory to chemoimmunotherapy or relapsing after second-line therapies, tisagenlecleucel compares favourably with respect to risk–benefit relative to conventional therapeutic approaches (eg, salvage chemotherapy).
Novartis Pharmaceuticals. In the primary analysis of the pivotal JULIET trial of tisagenlecleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, the best overall response rate was 52% and the complete response rate was 40% in 93 evaluable adult patients with relapsed or refractory aggressive B-cell lymphomas. We aimed to do a long-term follow-up analysis of the clinical outcomes and correlative analyses of activity and safety in the full adult cohort.BACKGROUNDIn the primary analysis of the pivotal JULIET trial of tisagenlecleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, the best overall response rate was 52% and the complete response rate was 40% in 93 evaluable adult patients with relapsed or refractory aggressive B-cell lymphomas. We aimed to do a long-term follow-up analysis of the clinical outcomes and correlative analyses of activity and safety in the full adult cohort.In this multicentre, open-label, single-arm, phase 2 trial (JULIET) done at 27 treatment sites in ten countries (Australia, Austria, Canada, France, Germany, Italy, Japan, the Netherlands, Norway, and the USA), adult patients (≥18 years) with histologically confirmed relapsed or refractory large B-cell lymphomas who were ineligible for, did not consent to, or had disease progression after autologous haematopoietic stem-cell transplantation, with an Eastern Cooperative Oncology Group performance status of 0-1 at screening, were enrolled. Patients received a single intravenous infusion of tisagenlecleucel (target dose 5 × 108 viable transduced CAR T cells). The primary endpoint was overall response rate (ie, the proportion of patients with a best overall disease response of a complete response or partial response using the Lugano classification, as assessed by an independent review committee) at any time post-infusion and was analysed in all patients who received tisagenlecleucel (the full analysis set). Safety was analysed in all patients who received tisagenlecleucel. JULIET is registered with ClinialTrials.gov, NCT02445248, and is ongoing.METHODSIn this multicentre, open-label, single-arm, phase 2 trial (JULIET) done at 27 treatment sites in ten countries (Australia, Austria, Canada, France, Germany, Italy, Japan, the Netherlands, Norway, and the USA), adult patients (≥18 years) with histologically confirmed relapsed or refractory large B-cell lymphomas who were ineligible for, did not consent to, or had disease progression after autologous haematopoietic stem-cell transplantation, with an Eastern Cooperative Oncology Group performance status of 0-1 at screening, were enrolled. Patients received a single intravenous infusion of tisagenlecleucel (target dose 5 × 108 viable transduced CAR T cells). The primary endpoint was overall response rate (ie, the proportion of patients with a best overall disease response of a complete response or partial response using the Lugano classification, as assessed by an independent review committee) at any time post-infusion and was analysed in all patients who received tisagenlecleucel (the full analysis set). Safety was analysed in all patients who received tisagenlecleucel. JULIET is registered with ClinialTrials.gov, NCT02445248, and is ongoing.Between July 29, 2015, and Nov 2, 2017, 167 patients were enrolled. As of Feb 20, 2020, 115 patients had received tisagenlecleucel infusion and were included in the full analysis set. At a median follow-up of 40·3 months (IQR 37·8-43·8), the overall response rate was 53·0% (95% CI 43·5-62·4; 61 of 115 patients), with 45 (39%) patients having a complete response as their best overall response. The most common grade 3-4 adverse events were anaemia (45 [39%]), decreased neutrophil count (39 [34%]), decreased white blood cell count (37 [32%]), decreased platelet count (32 [28%]), cytokine release syndrome (26 [23%]), neutropenia (23 [20%]), febrile neutropenia (19 [17%]), hypophosphataemia (15 [13%]), and thrombocytopenia (14 [12%]). The most common treatment-related serious adverse events were cytokine release syndrome (31 [27%]), febrile neutropenia (seven [6%]), pyrexia (six [5%]), pancytopenia (three [3%]), and pneumonia (three [3%]). No treatment-related deaths were reported.FINDINGSBetween July 29, 2015, and Nov 2, 2017, 167 patients were enrolled. As of Feb 20, 2020, 115 patients had received tisagenlecleucel infusion and were included in the full analysis set. At a median follow-up of 40·3 months (IQR 37·8-43·8), the overall response rate was 53·0% (95% CI 43·5-62·4; 61 of 115 patients), with 45 (39%) patients having a complete response as their best overall response. The most common grade 3-4 adverse events were anaemia (45 [39%]), decreased neutrophil count (39 [34%]), decreased white blood cell count (37 [32%]), decreased platelet count (32 [28%]), cytokine release syndrome (26 [23%]), neutropenia (23 [20%]), febrile neutropenia (19 [17%]), hypophosphataemia (15 [13%]), and thrombocytopenia (14 [12%]). The most common treatment-related serious adverse events were cytokine release syndrome (31 [27%]), febrile neutropenia (seven [6%]), pyrexia (six [5%]), pancytopenia (three [3%]), and pneumonia (three [3%]). No treatment-related deaths were reported.Tisagenlecleucel shows durable activity and manageable safety profiles in adult patients with relapsed or refractory aggressive B-cell lymphomas. For patients with large B-cell lymphomas that are refractory to chemoimmunotherapy or relapsing after second-line therapies, tisagenlecleucel compares favourably with respect to risk-benefit relative to conventional therapeutic approaches (eg, salvage chemotherapy).INTERPRETATIONTisagenlecleucel shows durable activity and manageable safety profiles in adult patients with relapsed or refractory aggressive B-cell lymphomas. For patients with large B-cell lymphomas that are refractory to chemoimmunotherapy or relapsing after second-line therapies, tisagenlecleucel compares favourably with respect to risk-benefit relative to conventional therapeutic approaches (eg, salvage chemotherapy).Novartis Pharmaceuticals.FUNDINGNovartis Pharmaceuticals. Summary Background In the primary analysis of the pivotal JULIET trial of tisagenlecleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, the best overall response rate was 52% and the complete response rate was 40% in 93 evaluable adult patients with relapsed or refractory aggressive B-cell lymphomas. We aimed to do a long-term follow-up analysis of the clinical outcomes and correlative analyses of activity and safety in the full adult cohort. Methods In this multicentre, open-label, single-arm, phase 2 trial (JULIET) done at 27 treatment sites in ten countries (Australia, Austria, Canada, France, Germany, Italy, Japan, the Netherlands, Norway, and the USA), adult patients (≥18 years) with histologically confirmed relapsed or refractory large B-cell lymphomas who were ineligible for, did not consent to, or had disease progression after autologous haematopoietic stem-cell transplantation, with an Eastern Cooperative Oncology Group performance status of 0–1 at screening, were enrolled. Patients received a single intravenous infusion of tisagenlecleucel (target dose 5 × 108 viable transduced CAR T cells). The primary endpoint was overall response rate (ie, the proportion of patients with a best overall disease response of a complete response or partial response using the Lugano classification, as assessed by an independent review committee) at any time post-infusion and was analysed in all patients who received tisagenlecleucel (the full analysis set). Safety was analysed in all patients who received tisagenlecleucel. JULIET is registered with ClinialTrials.gov, NCT02445248, and is ongoing. Findings Between July 29, 2015, and Nov 2, 2017, 167 patients were enrolled. As of Feb 20, 2020, 115 patients had received tisagenlecleucel infusion and were included in the full analysis set. At a median follow-up of 40·3 months (IQR 37·8–43·8), the overall response rate was 53·0% (95% CI 43·5–62·4; 61 of 115 patients), with 45 (39%) patients having a complete response as their best overall response. The most common grade 3–4 adverse events were anaemia (45 [39%]), decreased neutrophil count (39 [34%]), decreased white blood cell count (37 [32%]), decreased platelet count (32 [28%]), cytokine release syndrome (26 [23%]), neutropenia (23 [20%]), febrile neutropenia (19 [17%]), hypophosphataemia (15 [13%]), and thrombocytopenia (14 [12%]). The most common treatment-related serious adverse events were cytokine release syndrome (31 [27%]), febrile neutropenia (seven [6%]), pyrexia (six [5%]), pancytopenia (three [3%]), and pneumonia (three [3%]). No treatment-related deaths were reported. Interpretation Tisagenlecleucel shows durable activity and manageable safety profiles in adult patients with relapsed or refractory aggressive B-cell lymphomas. For patients with large B-cell lymphomas that are refractory to chemoimmunotherapy or relapsing after second-line therapies, tisagenlecleucel compares favourably with respect to risk–benefit relative to conventional therapeutic approaches (eg, salvage chemotherapy). Funding Novartis Pharmaceuticals. SummaryBackgroundIn the primary analysis of the pivotal JULIET trial of tisagenlecleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, the best overall response rate was 52% and the complete response rate was 40% in 93 evaluable adult patients with relapsed or refractory aggressive B-cell lymphomas. We aimed to do a long-term follow-up analysis of the clinical outcomes and correlative analyses of activity and safety in the full adult cohort. MethodsIn this multicentre, open-label, single-arm, phase 2 trial (JULIET) done at 27 treatment sites in ten countries (Australia, Austria, Canada, France, Germany, Italy, Japan, the Netherlands, Norway, and the USA), adult patients (≥18 years) with histologically confirmed relapsed or refractory large B-cell lymphomas who were ineligible for, did not consent to, or had disease progression after autologous haematopoietic stem-cell transplantation, with an Eastern Cooperative Oncology Group performance status of 0–1 at screening, were enrolled. Patients received a single intravenous infusion of tisagenlecleucel (target dose 5 × 10 8 viable transduced CAR T cells). The primary endpoint was overall response rate (ie, the proportion of patients with a best overall disease response of a complete response or partial response using the Lugano classification, as assessed by an independent review committee) at any time post-infusion and was analysed in all patients who received tisagenlecleucel (the full analysis set). Safety was analysed in all patients who received tisagenlecleucel. JULIET is registered with ClinialTrials.gov, NCT02445248, and is ongoing. FindingsBetween July 29, 2015, and Nov 2, 2017, 167 patients were enrolled. As of Feb 20, 2020, 115 patients had received tisagenlecleucel infusion and were included in the full analysis set. At a median follow-up of 40·3 months (IQR 37·8–43·8), the overall response rate was 53·0% (95% CI 43·5–62·4; 61 of 115 patients), with 45 (39%) patients having a complete response as their best overall response. The most common grade 3–4 adverse events were anaemia (45 [39%]), decreased neutrophil count (39 [34%]), decreased white blood cell count (37 [32%]), decreased platelet count (32 [28%]), cytokine release syndrome (26 [23%]), neutropenia (23 [20%]), febrile neutropenia (19 [17%]), hypophosphataemia (15 [13%]), and thrombocytopenia (14 [12%]). The most common treatment-related serious adverse events were cytokine release syndrome (31 [27%]), febrile neutropenia (seven [6%]), pyrexia (six [5%]), pancytopenia (three [3%]), and pneumonia (three [3%]). No treatment-related deaths were reported. InterpretationTisagenlecleucel shows durable activity and manageable safety profiles in adult patients with relapsed or refractory aggressive B-cell lymphomas. For patients with large B-cell lymphomas that are refractory to chemoimmunotherapy or relapsing after second-line therapies, tisagenlecleucel compares favourably with respect to risk–benefit relative to conventional therapeutic approaches (eg, salvage chemotherapy). FundingNovartis Pharmaceuticals. |
| Author | Kersten, Marie José Teshima, Takanori Holte, Harald Bishop, Michael R Hsu, Jing-Mei Damon, Lloyd E Salles, Gilles Tam, Constantine S Worel, Nina Izutsu, Koji Wagner-Johnston, Nina Kato, Koji Borchmann, Peter Ghosh, Monalisa Han, Xia Jaglowski, Samantha Fleury, Isabelle Westin, Jason R Martinez-Prieto, Marcela Ho, P Joy Maziarz, Richard T Corradini, Paolo McGuirk, Joseph P Schuster, Stephen J Foley, Stephen Ronan Mielke, Stephan Tiwari, Ranjan Janakiram, Murali Waller, Edmund K |
| Author_xml | – sequence: 1 givenname: Stephen J surname: Schuster fullname: Schuster, Stephen J email: stephen.schuster@pennmedicine.upenn.edu organization: Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA – sequence: 2 givenname: Constantine S surname: Tam fullname: Tam, Constantine S organization: Peter MacCallum Cancer Center, Royal Melbourne Hospital and University of Melbourne, Melbourne, VIC, Australia – sequence: 3 givenname: Peter surname: Borchmann fullname: Borchmann, Peter organization: Clinic I for Internal Medicine, University Hospital of Cologne, Cologne, Germany – sequence: 4 givenname: Nina surname: Worel fullname: Worel, Nina organization: Department of Blood Group Serology and Transfusion Medicine, Medical University of Vienna, Vienna, Austria – sequence: 5 givenname: Joseph P surname: McGuirk fullname: McGuirk, Joseph P organization: Department of Internal Medicine, The University of Kansas Health System, Kansas City, KS, USA – sequence: 6 givenname: Harald surname: Holte fullname: Holte, Harald organization: Department of Oncology, Oslo University Hospital, Oslo, Norway – sequence: 7 givenname: Edmund K surname: Waller fullname: Waller, Edmund K organization: Bone Marrow and Stem Cell Transplant Center, Emory University Winship Cancer Institute, Atlanta, GA, USA – sequence: 8 givenname: Samantha surname: Jaglowski fullname: Jaglowski, Samantha organization: Blood and Marrow Transplant Program, James Cancer Hospital and Solove Research Institute, Ohio State University Comprehensive Cancer Center, Columbus, OH, USA – sequence: 9 givenname: Michael R surname: Bishop fullname: Bishop, Michael R organization: Hematopoietic Cellular Therapy Program, Section of Hematology/Oncology, University of Chicago, Chicago, IL, USA – sequence: 10 givenname: Lloyd E surname: Damon fullname: Damon, Lloyd E organization: Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA – sequence: 11 givenname: Stephen Ronan surname: Foley fullname: Foley, Stephen Ronan organization: Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada – sequence: 12 givenname: Jason R surname: Westin fullname: Westin, Jason R organization: Department of Lymphoma and Myeloma, MD Anderson Cancer Center, Houston, TX, USA – sequence: 13 givenname: Isabelle surname: Fleury fullname: Fleury, Isabelle organization: Department of Lymphoma and Myeloma, Maisonneuve-Rosement Hospital, University of Montreal, Montreal, QC, Canada – sequence: 14 givenname: P Joy surname: Ho fullname: Ho, P Joy organization: Institute of Haematology, Royal Prince Alfred Hospital and University of Sydney, Camperdown, NSW, Australia – sequence: 15 givenname: Stephan surname: Mielke fullname: Mielke, Stephan organization: Department of Medicine II, University of Würzburg Medical Center, Würzburg, Germany – sequence: 16 givenname: Takanori surname: Teshima fullname: Teshima, Takanori organization: Department of Hematology, Hokkaido University Hospital, Sapporo, Japan – sequence: 17 givenname: Murali surname: Janakiram fullname: Janakiram, Murali organization: Division of Hematology, Oncology, and Transplantation, University of Minnesota, Minneapolis, MN, USA – sequence: 18 givenname: Jing-Mei surname: Hsu fullname: Hsu, Jing-Mei organization: Department of Medicine, Weill Cornell Medicine, NewYork-Presbyterian Hospital, New York, NY, USA – sequence: 19 givenname: Koji surname: Izutsu fullname: Izutsu, Koji organization: Department of Hematology, National Cancer Center Hospital, Tokyo, Japan – sequence: 20 givenname: Marie José surname: Kersten fullname: Kersten, Marie José organization: Department of Hematology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands – sequence: 21 givenname: Monalisa surname: Ghosh fullname: Ghosh, Monalisa organization: Department of Internal Medicine, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA – sequence: 22 givenname: Nina surname: Wagner-Johnston fullname: Wagner-Johnston, Nina organization: Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA – sequence: 23 givenname: Koji surname: Kato fullname: Kato, Koji organization: Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka, Japan – sequence: 24 givenname: Paolo surname: Corradini fullname: Corradini, Paolo organization: Fondazione IRCCS Istituto Nazionale dei Tumori, University of Milan, Milan, Italy – sequence: 25 givenname: Marcela surname: Martinez-Prieto fullname: Martinez-Prieto, Marcela organization: Novartis Pharmaceuticals, East Hanover, NJ, USA – sequence: 26 givenname: Xia surname: Han fullname: Han, Xia organization: Novartis Pharmaceuticals, East Hanover, NJ, USA – sequence: 27 givenname: Ranjan surname: Tiwari fullname: Tiwari, Ranjan organization: Novartis Healthcare, Hyderabad, India – sequence: 28 givenname: Gilles surname: Salles fullname: Salles, Gilles organization: Department of Hematology, Hospices Civils de Lyon, Lyon-Sud Hospital, Pierre-Bénite, France – sequence: 29 givenname: Richard T surname: Maziarz fullname: Maziarz, Richard T organization: Center for Hematologic Malignancies, Oregon Health and Science University Knight Cancer Institute, Portland, OR, USA |
| BackLink | http://kipublications.ki.se/Default.aspx?queryparsed=id:147888104$$DView record from Swedish Publication Index (Karolinska Institutet) |
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| Snippet | In the primary analysis of the pivotal JULIET trial of tisagenlecleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, the best... SummaryBackgroundIn the primary analysis of the pivotal JULIET trial of tisagenlecleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell... Summary Background In the primary analysis of the pivotal JULIET trial of tisagenlecleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell... |
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| StartPage | 1403 |
| SubjectTerms | Adverse events Antigens Autografts B-cell lymphoma Biomarkers CD19 antigen Cell therapy Chemotherapy Chimeric antigen receptors Clinical outcomes Cytokines Drug dosages FDA approval Fever Hematology, Oncology, and Palliative Medicine Hematopoietic stem cells Hypophosphatemia Immunotherapy Intravenous administration Leukocytes (neutrophilic) Lymphocytes Lymphocytes B Lymphocytes T Lymphoma Neutropenia Pancytopenia Patients Remission (Medicine) Response rates Safety Stem cell transplantation Thrombocytopenia Transplants & implants |
| Title | Long-term clinical outcomes of tisagenlecleucel in patients with relapsed or refractory aggressive B-cell lymphomas (JULIET): a multicentre, open-label, single-arm, phase 2 study |
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| Volume | 22 |
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