{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T19:19:26Z","timestamp":1793992766438,"version":"4.8.0"},"reference-count":32,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"15","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2021,5,20]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>CD19 chimeric antigen receptor (CD19-CAR) T cells induce high response rates in children and young adults (CAYAs) with B-cell acute lymphoblastic leukemia (B-ALL), but relapse rates are high. The role for allogeneic hematopoietic stem-cell transplant (alloHSCT) following CD19-CAR T-cell therapy to improve long-term outcomes in CAYAs has not been examined.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>We conducted a phase I trial of autologous CD19.28\u03b6-CAR T cells in CAYAs with relapsed or refractory B-ALL. Response and long-term clinical outcomes were assessed in relation to disease and treatment variables.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Fifty CAYAs with B-ALL were treated (median age, 13.5 years; range, 4.3-30.4). Thirty-one (62.0%) patients achieved a complete remission (CR), 28 (90.3%) of whom were minimal residual disease\u2212negative by flow cytometry. Utilization of fludarabine\/cyclophosphamide\u2013based lymphodepletion was associated with improved CR rates (29\/42, 69%) compared with non\u2013fludarabine\/cyclophosphamide\u2013based lymphodepletion (2\/8, 25%; P = .041). With median follow-up of 4.8 years, median overall survival was 10.5 months (95% CI, 6.3 to 29.2 months). Twenty-one of 28 (75.0%) patients achieving a minimal residual disease\u2212negative CR proceeded to alloHSCT. For those proceeding to alloHSCT, median overall survival was 70.2 months (95% CI, 10.4 months to not estimable). The cumulative incidence of relapse after alloHSCT was 9.5% (95% CI, 1.5 to 26.8) at 24 months; 5-year EFS following alloHSCT was 61.9% (95% CI, 38.1 to 78.8).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>We provide the longest follow-up in CAYAs with B-ALL after CD19-CAR T-cell therapy reported to date and demonstrate that sequential therapy with CD19.28\u03b6-CAR T cells followed by alloHSCT can mediate durable disease control in a sizable fraction of CAYAs with relapsed or refractory B-ALL (ClinicalTrials.gov identifier: NCT01593696 ).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.20.02262","type":"journal-article","created":{"date-parts":[[2021,3,25]],"date-time":"2021-03-25T16:01:00Z","timestamp":1616688060000},"page":"1650-1659","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":328,"title":["Long-Term Follow-Up of CD19-CAR T-Cell Therapy in Children and Young Adults With B-ALL"],"prefix":"10.1200","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8474-9080","authenticated-orcid":false,"given":"Nirali N.","family":"Shah","sequence":"first","affiliation":[{"name":"Pediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3249-9796","authenticated-orcid":false,"given":"Daniel W.","family":"Lee","sequence":"additional","affiliation":[{"name":"Pediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, MD"},{"name":"Division of Pediatric Hematology\/Oncology, Department of Pediatrics, University of Virginia, Charlottesville, VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonnie","family":"Yates","sequence":"additional","affiliation":[{"name":"Pediatric 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MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9319-6281","authenticated-orcid":false,"given":"Pamela L.","family":"Wolters","sequence":"additional","affiliation":[{"name":"Pediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8280-551X","authenticated-orcid":false,"given":"Seth M.","family":"Steinberg","sequence":"additional","affiliation":[{"name":"Biostatistics and Data Management Section, Office of the Clinical Director, Center for Cancer Research, Bethesda, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva H.","family":"Baker","sequence":"additional","affiliation":[{"name":"Department of Radiology and Imaging Sciences, NIH Clinical Center, Bethesda, 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