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Parsaclisib is a potent, selective next\u2010generation PI3K\u03b4 inhibitor that has demonstrated clinical efficacy and tolerability in phase II studies of patients with relapsed or refractory (R\/R) B\u2010cell NHL, including FL. We report results from CITADEL\u2010213 (NCT04434937), a phase II study evaluating the efficacy and safety of parsaclisib in Japanese patients with R\/R FL. Eligible patients were aged \u2265\u200918\u2009years with histologically confirmed R\/R FL (grade 1, 2, or 3a), had received two or more prior systemic therapies, and were ineligible for hematopoietic stem cell transplantation. Patients received parsaclisib 20\u2009mg once daily for 8\u2009weeks, followed by parsaclisib 2.5\u2009mg once daily thereafter. The primary endpoint was the objective response rate (ORR). At the data cut\u2010off (February 16, 2023), 42 patients had received treatment with parsaclisib, of whom 41 were evaluable for change in target tumor size. Median (range) age at baseline was 66.5 (52\u201387) years. ORR (95% confidence interval [CI]) was 88.1% (74.4\u201396.0), with 10 patients (23.8%) experiencing a complete response and 27 patients (64.3%) experiencing a partial response. Median (95% CI) duration of response was not reached (8.0\u2009months\u2212not estimable). The most common treatment\u2010emergent adverse events (TEAEs) were diarrhea (28.6%; grade \u2265\u20093, 7.1%) and stomatitis (23.8%; grade \u2265\u20093, 11.9%); TEAEs led to parsaclisib discontinuation in five patients (11.9%). There were no fatal TEAEs. In conclusion, parsaclisib monotherapy demonstrated durable responses with a manageable safety profile in Japanese patients with R\/R FL.<\/jats:p><jats:p><jats:bold>Trial Registration:<\/jats:bold> <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>, NCT04434937<\/jats:p>","DOI":"10.1111\/cas.70046","type":"journal-article","created":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T06:41:10Z","timestamp":1747204870000},"page":"2189-2197","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["<scp>PI3K\u03b4<\/scp> Inhibitor Parsaclisib in Japanese Patients With Relapsed or Refractory Follicular Lymphoma"],"prefix":"10.1111","volume":"116","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2682-2179","authenticated-orcid":false,"given":"Noriko","family":"Fukuhara","sequence":"first","affiliation":[{"name":"Tohoku University Hospital  Sendai Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isao","family":"Yoshida","sequence":"additional","affiliation":[{"name":"NHO Shikoku Cancer Center  Matsuyama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuro","family":"Ishiguro","sequence":"additional","affiliation":[{"name":"Niigata Cancer Center Hospital  Niigata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuya","family":"Fujimoto","sequence":"additional","affiliation":[{"name":"NHO Hokkaido Cancer Center  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6130-1550","authenticated-orcid":false,"given":"Junya","family":"Kuroda","sequence":"additional","affiliation":[{"name":"Kyoto Prefectural University of Medicine  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiki","family":"Uchida","sequence":"additional","affiliation":[{"name":"Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryusuke","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Kobe City Medical Center General Hospital  Kobe Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiaki","family":"Ogawa","sequence":"additional","affiliation":[{"name":"Tokai University Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasushi","family":"Hiramatsu","sequence":"additional","affiliation":[{"name":"Japanese Red Cross Society Himeji Hospital  Himeji Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiro","family":"Ito","sequence":"additional","affiliation":[{"name":"NHO Matsumoto Medical Center  Matsumoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seiichiro","family":"Katagiri","sequence":"additional","affiliation":[{"name":"Tokyo Medical University Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomonori","family":"Nakazato","sequence":"additional","affiliation":[{"name":"Yokohama Municipal Citizen's Hospital  Yokohama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazumi","family":"Suzukawa","sequence":"additional","affiliation":[{"name":"Incyte Biosciences Japan G.K.  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