{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T18:18:36Z","timestamp":1769105916989,"version":"3.49.0"},"reference-count":25,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2022,3,15]],"date-time":"2022-03-15T00:00:00Z","timestamp":1647302400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100017655","name":"Incyte","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017655","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Parsaclisib, a potent, selective, next\u2010generation PI3K\u03b4 inhibitor, has shown clinical benefit in patients with relapsed or refractory B\u2010cell lymphoma. We undertook a phase Ib study (CITADEL\u2010111) evaluating safety, pharmacokinetics, and efficacy of parsaclisib in Japanese patients with relapsed or refractory B\u2010cell malignancies. Patients received oral parsaclisib daily for 8\u00a0weeks then once weekly (10\u2010mg dose, n\u00a0=\u00a03; 20\u2010mg dose, n\u00a0=\u00a014). Pharmacokinetic samples were collected on days 1, 8, and 15, and efficacy was monitored according to Lugano criteria. At data cut\u2010off (August 14, 2020), 6 patients (35.3%) remained on study treatment and 11 (64.7%) discontinued due to progressive disease (9 [52.9%]) or adverse events (2 [11.8%]). Median duration of treatment was 8.3 (range, 0.3\u201324.4) months. The most commonly reported nonhematologic adverse events were constipation (6 [35.3%]), nausea, and pyrexia (each 4 [23.5%]). Five patients (29.4%) experienced treatment\u2010emergent new or worsening decreased neutrophils to grade 3 or 4. No treatment\u2010emergent worsening in aminotransferase elevations to grade 3 or 4 were observed. Ten patients (58.8%) required dose interruption and 5 (29.4%) dose reduction. Body weight\u2013normalized parsaclisib exposure was comparable between Japanese and Western patients. Objective response rate was 100% in follicular lymphoma (9 of 9 patients, including complete response in 2 patients [22.2%]) and marginal zone lymphoma (2 of 2 patients), and 16.7% in diffuse large B\u2010cell lymphoma (1 of 6 patients). Results observed in Japanese patients with relapsed or refractory follicular or marginal zone lymphoma support further clinical development of parsaclisib in these patient populations.<\/jats:p>","DOI":"10.1111\/cas.15308","type":"journal-article","created":{"date-parts":[[2022,2,24]],"date-time":"2022-02-24T15:16:07Z","timestamp":1645715767000},"page":"1702-1711","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Parsaclisib in Japanese patients with relapsed or refractory B\u2010cell lymphoma (CITADEL\u2010111): A phase Ib study"],"prefix":"10.1111","volume":"113","author":[{"given":"Noriko","family":"Fukuhara","sequence":"first","affiliation":[{"name":"Department of Hematology Tohoku University Hospital  Sendai Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Youko","family":"Suehiro","sequence":"additional","affiliation":[{"name":"Department of Hematology National Hospital Organization Kyushu Cancer Center  Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harumi","family":"Kato","sequence":"additional","affiliation":[{"name":"Department of Hematology and Cell Therapy Aichi Cancer Center Hospital  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6546-1279","authenticated-orcid":false,"given":"Shigeru","family":"Kusumoto","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Nagoya City University Graduate School of Medical Sciences  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cinthya","family":"Coronado","sequence":"additional","affiliation":[{"name":"Incyte Corporation  Wilmington Delaware USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erica","family":"Rappold","sequence":"additional","affiliation":[{"name":"Incyte Corporation  Wilmington Delaware USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wanying","family":"Zhao","sequence":"additional","affiliation":[{"name":"Incyte Corporation  Wilmington Delaware USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jia","family":"Li","sequence":"additional","affiliation":[{"name":"Incyte Corporation  Wilmington Delaware USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aidan","family":"Gilmartin","sequence":"additional","affiliation":[{"name":"Incyte Corporation  Wilmington Delaware USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9129-8057","authenticated-orcid":false,"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[{"name":"Department of Hematology National Cancer Center Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,3,15]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)32407-2"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.2217\/ijh-2016-0003"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1080\/13543784.2018.1482273"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers12061396"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/joim.12600"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2020.1737010"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clml.2020.08.022"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11864-020-00746-8"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx289"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41375-020-0743-y"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/PPO.0000000000000414"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1314583"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.18.00915"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.120.265538"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.20.03433"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2018-08-867499"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1080\/10428194.2020.1832660"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2020-134869"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2020-134872"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2020-134609"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2020-134451"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1653"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.54.8800"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2013-11-535047"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2017-05-786566"}],"container-title":["Cancer Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cas.15308","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cas.15308","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cas.15308","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,6]],"date-time":"2024-08-06T11:16:14Z","timestamp":1722942974000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/cas.15308"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3,15]]},"references-count":25,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2022,5]]}},"alternative-id":["10.1111\/cas.15308"],"URL":"https:\/\/doi.org\/10.1111\/cas.15308","archive":["Portico"],"relation":{},"ISSN":["1347-9032","1349-7006"],"issn-type":[{"value":"1347-9032","type":"print"},{"value":"1349-7006","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,3,15]]},"assertion":[{"value":"2021-11-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-02-16","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-03-15","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}