{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T15:50:28Z","timestamp":1793893828826,"version":"4.8.0"},"reference-count":37,"publisher":"American Society of Hematology","issue":"17","license":[{"start":{"date-parts":[[2024,1,9]],"date-time":"2024-01-09T00:00:00Z","timestamp":1704758400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,4,25]]},"abstract":"<jats:sec>\n                    <jats:title>Abstract<\/jats:title>\n                    <jats:p>Tisagenlecleucel is approved for adults with relapsed\/refractory (r\/r) follicular lymphoma (FL) in the third- or later-line setting. The primary analysis (median follow-up, 17 months) of the phase 2 ELARA trial reported high response rates and excellent safety profile in patients with extensively pretreated r\/r FL. Here, we report longer-term efficacy, safety, pharmacokinetic, and exploratory biomarker analyses after median follow-up of 29 months (interquartile range, 22.2-37.7). As of 29 March 2022, 97 patients with r\/r FL (grades 1-3A) received tisagenlecleucel infusion (0.6\u00a0\u00d7 108-6\u00a0\u00d7 108 chimeric antigen receptor\u2013positive viable T cells). Bridging chemotherapy was allowed. Baseline clinical factors, tumor microenvironment, blood soluble factors, and circulating blood cells were correlated with clinical response. Cellular kinetics were assessed by quantitative polymerase chain reaction. Median progression-free survival (PFS), duration of response (DOR), and overall survival (OS) were not reached. Estimated 24-month PFS, DOR, and OS rates in all patients were 57.4% (95% confidence interval [CI], 46.2-67), 66.4% (95% CI, 54.3-76), and 87.7% (95% CI, 78.3-93.2), respectively. Complete response rate and overall response rate were 68.1% (95% CI, 57.7-77.3) and 86.2% (95% CI, 77.5-92.4), respectively. No new safety signals or treatment-related deaths were reported. Low levels of tumor-infiltrating LAG3+CD3+ exhausted T cells and higher baseline levels of na\u00efve CD8+ T cells were associated with improved outcomes. Tisagenlecleucel continued to demonstrate highly durable efficacy and a favorable safety profile in this extended follow-up of 29 months in patients with r\/r FL enrolled in ELARA. This trial was registered at www.clinicaltrials.gov as #NCT03568461.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1182\/blood.2023021567","type":"journal-article","created":{"date-parts":[[2024,1,9]],"date-time":"2024-01-09T17:15:56Z","timestamp":1704820556000},"page":"1713-1725","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":108,"title":["Durable response after tisagenlecleucel in adults with relapsed\/refractory follicular lymphoma: ELARA trial update"],"prefix":"10.1182","volume":"143","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0358-5249","authenticated-orcid":false,"given":"Martin","family":"Dreyling","sequence":"first","affiliation":[{"name":"1Department of Medicine, Medical Clinic III, Ludwig-Maximilian-University Hospital, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9494-1877","authenticated-orcid":false,"given":"Nathan Hale","family":"Fowler","sequence":"additional","affiliation":[{"name":"2The University of Texas MD Anderson Cancer Center, Houston, TX"},{"name":"3BostonGene, Waltham, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1492-5966","authenticated-orcid":false,"given":"Michael","family":"Dickinson","sequence":"additional","affiliation":[{"name":"4Peter MacCallum Cancer Centre, Royal Melbourne Hospital and the Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7908-0063","authenticated-orcid":false,"given":"Joaquin","family":"Martinez-Lopez","sequence":"additional","affiliation":[{"name":"5Hospital 12 De Octubre, Complutense University, Centro Nacional de Investigaciones Oncol\u00f3gicas, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arne","family":"Kolstad","sequence":"additional","affiliation":[{"name":"6Oslo University Hospital, Oslo, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6422-4404","authenticated-orcid":false,"given":"Jason","family":"Butler","sequence":"additional","affiliation":[{"name":"7Royal Brisbane Hospital, Herston, QLD, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2260-8212","authenticated-orcid":false,"given":"Monalisa","family":"Ghosh","sequence":"additional","affiliation":[{"name":"8Division of Hematology\/Oncology, Michigan Medicine University of Michigan, Ann Arbor, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8418-2811","authenticated-orcid":false,"given":"Leslie","family":"Popplewell","sequence":"additional","affiliation":[{"name":"9City of Hope Comprehensive Cancer Center, Duarte, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2045-6238","authenticated-orcid":false,"given":"Julio C.","family":"Chavez","sequence":"additional","affiliation":[{"name":"10Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2694-7510","authenticated-orcid":false,"given":"Emmanuel","family":"Bachy","sequence":"additional","affiliation":[{"name":"11Clinical Hematology, Hospices Civils de Lyon and Universit\u00e9 Claude Bernard Lyon 1, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Kato","sequence":"additional","affiliation":[{"name":"12Department of Hematology, Oncology, and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4849-7442","authenticated-orcid":false,"given":"Hideo","family":"Harigae","sequence":"additional","affiliation":[{"name":"13Department of Hematology, Tohoku University Hospital, Sendai, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8904-3802","authenticated-orcid":false,"given":"Marie Jos\u00e9","family":"Kersten","sequence":"additional","affiliation":[{"name":"14Department of Hematology, Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands, on behalf of Stichting Hemato-Oncologie voor Volwassenen Nederland\/Lunenburg Lymphoma Phase I\/II Consortium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4681-6227","authenticated-orcid":false,"given":"Charalambos","family":"Andreadis","sequence":"additional","affiliation":[{"name":"15Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2719-0580","authenticated-orcid":false,"given":"Peter A.","family":"Riedell","sequence":"additional","affiliation":[{"name":"16David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2811-8671","authenticated-orcid":false,"given":"P. Joy","family":"Ho","sequence":"additional","affiliation":[{"name":"17Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9 Antonio","family":"P\u00e9rez-Sim\u00f3n","sequence":"additional","affiliation":[{"name":"18Department of Hematology, University Hospital Virgen del Roc\u00edo, Instituto de Biomedicina de Sevilla Consejo Superior de Investigaciones Cientificas, Universidad de Sevilla, Seville, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andy I.","family":"Chen","sequence":"additional","affiliation":[{"name":"19Oregon Health and Science University, Portland, OR"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6071-8610","authenticated-orcid":false,"given":"Loretta J.","family":"Nastoupil","sequence":"additional","affiliation":[{"name":"20Department of Lymphoma\/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1410-4487","authenticated-orcid":false,"given":"Bastian","family":"von Tresckow","sequence":"additional","affiliation":[{"name":"21Department I of Internal Medicine, Medical Faculty and University Hospital Cologne, University of Cologne, Cologne, Germany"},{"name":"22Department of Hematology and Stem Cell Transplantation, West German Cancer Center and German Cancer Consortium, University Hospital Essen, University of Duisburg-Essen, Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9606-6124","authenticated-orcid":false,"given":"Andr\u00e9s Jos\u00e9","family":"Mar\u00eda Ferreri","sequence":"additional","affiliation":[{"name":"23Unit of Lymphoid Malignancies, Department of Onco-Haematology, IRCCS San Raffaele Scientific Institute, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0941-271X","authenticated-orcid":false,"given":"Takanori","family":"Teshima","sequence":"additional","affiliation":[{"name":"24Department of Hematology, Hokkaido University Hospital, Sapporo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3320-3034","authenticated-orcid":false,"given":"Piers E. M.","family":"Patten","sequence":"additional","affiliation":[{"name":"25Comprehensive Cancer Centre, King\u2019s College London, London, United Kingdom"},{"name":"26Department of Haematology, King\u2019s College Hospital, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0539-4796","authenticated-orcid":false,"given":"Joseph P.","family":"McGuirk","sequence":"additional","affiliation":[{"name":"27Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Cancer l Center, Westwood, KS"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas L.","family":"Petzer","sequence":"additional","affiliation":[{"name":"28Internal Medicine I, Ordensklinikum Linz Barmherzige Schwestern-Elisabethinen, Linz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fritz","family":"Offner","sequence":"additional","affiliation":[{"name":"29Universitair Ziekenhuis Gent, Ghent, 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