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Patients received cyclophosphamide and fludarabine followed by 1\u2009\u00d7\u200910<jats:sup>6<\/jats:sup> ARI\u20100001 cells\/kg, initially as a single dose (first patient) and later split into three fractions (10%, 30%, and 60%). Cytokine release syndrome (CRS) occurred in 50% (9\/18) of patients, with no cases of grade\u2009\u22653 CRS, and 1 case (6%) of grade 1 neurotoxicity. Tocilizumab was used in 6% of patients (1\/18). Procedure\u2010related mortality was 0% at 2\u2009years. Objective responses were seen in 94% (95% confidence interval [CI]: 73%\u201399%) of patients, with complete responses (CR) seen in 78% (95% CI: 52%\u201394%) of them. Progression\u2010free and overall survival were 49% (95% CI: 30%\u201379%) and 61% (95% CI: 40%\u201392%) at 2\u2009years. In conclusion, the use of ARI\u20100001 cells in patients with R\/R ALL and iEMD was associated with a safety and efficacy profile that is comparable with what is observed in patients with marrow involvement and in line with other CART19 products.<\/jats:p>","DOI":"10.1002\/ajh.26519","type":"journal-article","created":{"date-parts":[[2022,3,7]],"date-time":"2022-03-07T12:41:22Z","timestamp":1646656882000},"page":"731-739","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Results of <scp>ARI<\/scp>\u20100001 <scp>CART19<\/scp> cell therapy in patients with relapsed\/refractory <scp>CD19<\/scp>\u2010positive acute lymphoblastic leukemia with isolated extramedullary disease"],"prefix":"10.1002","volume":"97","author":[{"given":"Valent\u00edn","family":"Ortiz\u2010Maldonado","sequence":"first","affiliation":[{"name":"Department of Hematology Hospital Cl\u00ednic  Barcelona Spain"},{"name":"Oncology &amp; Haematology 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