{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,5]],"date-time":"2026-07-05T00:19:06Z","timestamp":1783210746377,"version":"3.54.6"},"reference-count":45,"publisher":"Elsevier BV","issue":"7","license":[{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2027,6,29]],"date-time":"2027-06-29T00:00:00Z","timestamp":1814227200000},"content-version":"am","delay-in-days":363,"URL":"http:\/\/www.elsevier.com\/open-access\/userlicense\/1.0\/"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Institutes of Health National Cancer Institute","doi-asserted-by":"publisher","award":["U24CA076518"],"award-info":[{"award-number":["U24CA076518"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Transplantation and Cellular Therapy"],"published-print":{"date-parts":[[2026,7]]},"DOI":"10.1016\/j.jtct.2026.03.016","type":"journal-article","created":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T16:12:10Z","timestamp":1773763930000},"page":"832-847","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":1,"title":["Statistical Methods for Chimeric Antigen Receptor Cell Therapy Outcomes: A Review and Practical Considerations"],"prefix":"10.1016","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1404-0575","authenticated-orcid":false,"given":"Soyoung","family":"Kim","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4567-8037","authenticated-orcid":false,"given":"Kwang Woo","family":"Ahn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brent","family":"Logan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9239-5884","authenticated-orcid":false,"given":"Ruta","family":"Brazauskas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcelo","family":"Pasquini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5110-004X","authenticated-orcid":false,"given":"Amy","family":"Moskop","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.jtct.2026.03.016_bib0001","unstructured":"Food and Drug Administration. Summary Basis for Regulatory Action and Summary of Product Characteristics-KYMRIAH. (2018)."},{"key":"10.1016\/j.jtct.2026.03.016_bib0002","unstructured":"Food and Drug Administration. Summary Basis for Regulatory Action -YESCAR-T CELL THERAPY A. (2017)."},{"key":"10.1016\/j.jtct.2026.03.016_bib0003","unstructured":"Food and Drug Administration. Summary Basis for Regulatory Action -TECAR-T CELL THERAPY US. (2024)."},{"key":"10.1016\/j.jtct.2026.03.016_bib0004","unstructured":"Food and Drug Administration. Summary Basis for Regulatory Action -CARVYKTI. (2022)."},{"key":"10.1016\/j.jtct.2026.03.016_bib0005","unstructured":"Food and Drug Administration. Summary Basis for Regulatory Action -BREYANZI. (2019)."},{"key":"10.1016\/j.jtct.2026.03.016_bib0006","unstructured":"Food and Drug Administration. Summary Basis for Regulatory Action -ABECMA. (2021)."},{"issue":"14","key":"10.1016\/j.jtct.2026.03.016_bib0007","doi-asserted-by":"crossref","first-page":"1331","DOI":"10.1056\/NEJMoa1914347","article-title":"KTE-X19 CAR T-cell therapy in relapsed or refractory mantle-cell lymphoma","volume":"382","author":"Wang","year":"2020","journal-title":"N Engl J Med"},{"issue":"26","key":"10.1016\/j.jtct.2026.03.016_bib0008","doi-asserted-by":"crossref","first-page":"2531","DOI":"10.1056\/NEJMoa1707447","article-title":"Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma","volume":"377","author":"Neelapu","year":"2017","journal-title":"N Engl J Med"},{"issue":"1","key":"10.1016\/j.jtct.2026.03.016_bib0009","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1056\/NEJMoa1804980","article-title":"Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma","volume":"380","author":"Schuster","year":"2019","journal-title":"N Engl J Med"},{"issue":"1","key":"10.1016\/j.jtct.2026.03.016_bib0010","first-page":"218","article-title":"Outcomes of patients with primary central nervous system lymphoma following CD19-targeted chimeric antigen receptor T-cell therapy","volume":"110","author":"Mercadal","year":"2025","journal-title":"Haematologica"},{"issue":"3","key":"10.1016\/j.jtct.2026.03.016_bib0011","doi-asserted-by":"crossref","first-page":"259","DOI":"10.1038\/s41409-024-02496-9","article-title":"Anti-CD19 CAR T-cell therapy for primary and secondary CNS lymphomas","volume":"60","author":"Losi","year":"2025","journal-title":"Bone Marrow Transplant"},{"issue":"1","key":"10.1016\/j.jtct.2026.03.016_bib0012","doi-asserted-by":"crossref","DOI":"10.1016\/j.jtct.2023.10.017","article-title":"Real-world outcomes with chimeric antigen receptor T cell therapies in large B cell lymphoma: a systematic review and meta-analysis","volume":"30","author":"Jacobson","year":"2024","journal-title":"Transplant Cell Ther"},{"issue":"8-9","key":"10.1016\/j.jtct.2026.03.016_bib0013","doi-asserted-by":"crossref","first-page":"1080","DOI":"10.1038\/s41417-021-00418-1","article-title":"Use of CAR T-cell for acute lymphoblastic leukemia (ALL) treatment: a review study","volume":"29","author":"Sheykhhasan","year":"2022","journal-title":"Cancer Gene Ther"},{"issue":"6","key":"10.1016\/j.jtct.2026.03.016_bib0014","doi-asserted-by":"crossref","first-page":"359","DOI":"10.1038\/s41571-023-00754-1","article-title":"Long-term outcomes following CAR T cell therapy: what we know so far","volume":"20","author":"Cappell","year":"2023","journal-title":"Nat Rev Clin Oncol"},{"issue":"10299","key":"10.1016\/j.jtct.2026.03.016_bib0015","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1016\/S0140-6736(21)01222-8","article-title":"KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study","volume":"398","author":"Shah","year":"2021","journal-title":"Lancet"},{"issue":"S1","key":"10.1016\/j.jtct.2026.03.016_bib0016","doi-asserted-by":"crossref","first-page":"S3","DOI":"10.1002\/ajh.25418","article-title":"An introduction to chimeric antigen receptor (CAR) T-cell immunotherapy for human cancer","volume":"94","author":"Feins","year":"2019","journal-title":"Am J Hematol"},{"key":"10.1016\/j.jtct.2026.03.016_bib0017","unstructured":"Food and Drug Administration. Summary Basis for Regulatory Action -AUCATZL. (2024)."},{"key":"10.1016\/j.jtct.2026.03.016_bib0018","unstructured":"Food and Drug Administration. Summary Basis for Regulatory Action -TECELRA. (2024)."},{"key":"10.1016\/j.jtct.2026.03.016_bib0019","unstructured":"Food and Drug Administration. Summary Basis for Regulatory Action -AMTAGVI. (2024)."},{"issue":"4","key":"10.1016\/j.jtct.2026.03.016_bib0020","doi-asserted-by":"crossref","DOI":"10.1016\/j.jtct.2024.11.012","article-title":"Inconsistent reporting and definitions of time-to-event endpoints in CAR T clinical trials: A review","volume":"31","author":"Grady","year":"2025","journal-title":"Transplant Cell Ther"},{"issue":"18","key":"10.1016\/j.jtct.2026.03.016_bib0021","doi-asserted-by":"crossref","first-page":"3940","DOI":"10.1158\/1078-0432.CCR-22-0560","article-title":"Statistical considerations for analyses of time-to-event endpoints in oncology clinical trials: illustrations with CAR-T immunotherapy studies","volume":"28","author":"Li","year":"2022","journal-title":"Clin Cancer Res"},{"key":"10.1016\/j.jtct.2026.03.016_bib0022","unstructured":"Hrain Biotechnology Co., Ltd. Human CD19-targeted T cell injection (CD19 CAR-T) therapy for relapsed and refractory CD19-positive lymphoma [clinical trial]. ClinicalTrials.gov identifier: NCT03720457. Bethesda (MD): National Library of Medicine (US); 2018\u20132021. Available from: ClinicalTrials.gov."},{"key":"10.1016\/j.jtct.2026.03.016_bib0023","series-title":"Phase 1 study of autologous CD30.CAR-T in relapsed or refractory CD30-positive non-Hodgkin lymphoma [clinical trial]. ClinicalTrials.gov Identifier: NCT04526834","year":"2020"},{"issue":"5","key":"10.1016\/j.jtct.2026.03.016_bib0024","doi-asserted-by":"crossref","first-page":"709","DOI":"10.1002\/pst.2386","article-title":"Time-to-event estimands and loss to follow-up in oncology in light of the estimands guidance","volume":"23","author":"Siegel","year":"2024","journal-title":"Pharm Stat"},{"issue":"7","key":"10.1016\/j.jtct.2026.03.016_bib0025","doi-asserted-by":"crossref","first-page":"1436","DOI":"10.1093\/annonc\/mdx097","article-title":"International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017)","volume":"28","author":"Younes","year":"2017","journal-title":"Ann Oncol"},{"issue":"24","key":"10.1016\/j.jtct.2026.03.016_bib0026","doi-asserted-by":"crossref","first-page":"5568","DOI":"10.1002\/cncr.25354","article-title":"Defining the course and prognosis of adults with acute lymphocytic leukemia in first salvage after induction failure or short first remission duration","volume":"116","author":"Kantarjian","year":"2010","journal-title":"Cancer"},{"issue":"9","key":"10.1016\/j.jtct.2026.03.016_bib0027","doi-asserted-by":"crossref","first-page":"1467","DOI":"10.1038\/sj.leu.2404284","article-title":"International uniform response criteria for multiple myeloma","volume":"20","author":"Durie","year":"2006","journal-title":"Leukemia"},{"issue":"4","key":"10.1016\/j.jtct.2026.03.016_bib0028","doi-asserted-by":"crossref","first-page":"541","DOI":"10.2307\/2530374","article-title":"The analysis of failure times in the presence of competing risks","volume":"34","author":"Prentice","year":"1978","journal-title":"Biometrics"},{"key":"10.1016\/j.jtct.2026.03.016_bib0029","doi-asserted-by":"crossref","DOI":"10.1002\/9781118032985","author":"Kalbfleisch","year":"2002","journal-title":"The Statistical Analysis of Failure Time Data"},{"issue":"446","key":"10.1016\/j.jtct.2026.03.016_bib0030","doi-asserted-by":"crossref","first-page":"496","DOI":"10.1080\/01621459.1999.10474144","article-title":"A proportional hazards model for the subdistribution of a competing risk","volume":"94","author":"Fine","year":"1999","journal-title":"J Am Stat Assoc"},{"issue":"4","key":"10.1016\/j.jtct.2026.03.016_bib0031","first-page":"1121","article-title":"Clinical endpoints in oncology - a primer","volume":"11","author":"Delgado","year":"2021","journal-title":"Am J Cancer Res"},{"issue":"5","key":"10.1016\/j.jtct.2026.03.016_bib0032","doi-asserted-by":"crossref","first-page":"541","DOI":"10.1177\/17407745241264188","article-title":"Inferences for the distribution of the duration of response in a comparative clinical study","volume":"21","author":"Cui","year":"2024","journal-title":"Clin Trials"},{"issue":"2","key":"10.1016\/j.jtct.2026.03.016_bib0033","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1111\/j.2517-6161.1972.tb00899.x","article-title":"Regression models and life-tables","volume":"34","author":"Cox","year":"1972","journal-title":"J R Stat Soc Series B Stat Methodol"},{"key":"10.1016\/j.jtct.2026.03.016_bib0034","unstructured":"International Council for Harmonisation. ICH Harmonised Guideline: E9(R1), Statistical Principles for Clinical Trials: Addendum on Estimands and Sensitivity Analysis in Clinical Trials. 2019. Available at: https:\/\/www.ich.org\/page\/efficacy-guidelines. Accessed April 14, 2026."},{"issue":"6","key":"10.1016\/j.jtct.2026.03.016_bib0035","doi-asserted-by":"crossref","first-page":"653","DOI":"10.1080\/14712598.2020.1729735","article-title":"Assessment and management of cytokine release syndrome and neurotoxicity following CD19 CAR-T cell therapy","volume":"20","author":"Chou","year":"2020","journal-title":"Expert Opin Biol Ther"},{"issue":"9","key":"10.1016\/j.jtct.2026.03.016_bib0036","doi-asserted-by":"crossref","first-page":"876","DOI":"10.1016\/j.jtct.2024.06.012","article-title":"Timing of toxicities and non-relapse mortality following CAR T therapy in myeloma","volume":"30","author":"Wesson","year":"2024","journal-title":"Transplant Cell Ther"},{"issue":"4","key":"10.1016\/j.jtct.2026.03.016_bib0037","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1016\/j.bbmt.2018.12.758","article-title":"ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells","volume":"25","author":"Lee","year":"2019","journal-title":"Biol Blood Marrow Transplant"},{"key":"10.1016\/j.jtct.2026.03.016_bib0038","unstructured":"Cleveland Clinic. Cytopenia [Internet]. Available at:https:\/\/my.clevelandclinic.org\/health\/diseases\/24864-cytopenia. Accessed January 7, 2025."},{"key":"10.1016\/j.jtct.2026.03.016_bib0039","doi-asserted-by":"crossref","unstructured":"Frey N, Porter D. Cytokine release syndrome with chimeric antigen receptor T cell therapy. Biol Blood Marrow Transplant. 2019;25(4):e123-e127.","DOI":"10.1016\/j.bbmt.2018.12.756"},{"key":"10.1016\/j.jtct.2026.03.016_bib0040","first-page":"85","article-title":"Cytokine release syndrome and associated neurotoxicity in cancer immunotherapy","volume":"22","author":"Morris","year":"2022"},{"issue":"8","key":"10.1016\/j.jtct.2026.03.016_bib0041","article-title":"Prolonged cytopenia following CD19 CAR T cell therapy is linked with bone marrow infiltration of clonally expanded IFN\u03b3-expressing CD8 T cells","volume":"4","author":"Strati","year":"2023","journal-title":"Cell Rep Med"},{"issue":"20","key":"10.1016\/j.jtct.2026.03.016_bib0042","first-page":"2460","article-title":"How I treat cytopenias after CAR T-cell therapy","volume":"141","author":"Jain","year":"2023","journal-title":"Blood"},{"key":"10.1016\/j.jtct.2026.03.016_bib0043","first-page":"1","article-title":"mice: Multivariate imputation by chained equations in R","volume":"45(3)","author":"van Buuren","year":"2011","journal-title":"J Stat Softw"},{"key":"10.1016\/j.jtct.2026.03.016_bib0044","doi-asserted-by":"crossref","unstructured":"Kim S, Logan B, Riches M, Chen M, Ahn KW. Statistical methods for time-dependent variables in hematopoietic cell transplantation studies. Transplant Cell Ther. 2021;27(2):125-132.","DOI":"10.1016\/j.bbmt.2020.09.034"},{"key":"10.1016\/j.jtct.2026.03.016_bib0045","doi-asserted-by":"crossref","unstructured":"Andersen PK, Klein JP. Regression analysis for multistate models based on a pseudo-value approach, with applications to bone marrow transplantation studies. Scand J Stat. 2007;34(1):3-16.","DOI":"10.1111\/j.1467-9469.2006.00526.x"}],"container-title":["Transplantation and Cellular Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2666636726002241?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2666636726002241?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,7,5]],"date-time":"2026-07-05T00:02:15Z","timestamp":1783209735000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2666636726002241"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":45,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["S2666636726002241"],"URL":"https:\/\/doi.org\/10.1016\/j.jtct.2026.03.016","relation":{},"ISSN":["2666-6367"],"issn-type":[{"value":"2666-6367","type":"print"}],"subject":[],"published":{"date-parts":[[2026,7]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Statistical Methods for Chimeric Antigen Receptor Cell Therapy Outcomes: A Review and Practical Considerations","name":"articletitle","label":"Article Title"},{"value":"Transplantation and Cellular Therapy","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jtct.2026.03.016","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}]}}