{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T13:04:58Z","timestamp":1789563898870,"version":"build-2803163510"},"reference-count":31,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,16]],"date-time":"2026-08-16T00:00:00Z","timestamp":1786838400000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Reports"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Denileukin diftitox (DD)\u2010cxdl, a fusion protein comprising diphtheria toxin fragments and human interleukin\u20102, is a treatment for peripheral T\u2010cell lymphoma (PTCL) and cutaneous T\u2010cell lymphoma (CTCL). Previous trials have enrolled a limited number of patients, and there is a need to evaluate DD\u2010cxdl in a more diverse population, including those with different ages and treatment histories.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This observational post\u2010marketing study (19 May 2021 to 1 February 2024) was conducted in over 200 institutions in Japan to evaluate the safety and effectiveness of DD\u2010cxdl in patients with relapsed or refractory PTCL and CTCL (NCT05137847; jRCT2031220196). Patient characteristics, status of drug administration, adverse events (AEs), adverse drug reactions (ADRs), and effectiveness were assessed. Capillary leak syndrome was specified as an AE of special interest.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Data from 104 patients were analyzed (PTCL: 85; CTCL: 19), including 57 male patients (54.8%). The median age was 74 (range: 20\u201388) years. The median number of prior chemotherapy lines was 3.5 (1.0\u201310.0), and approximately half (55.8%) of the patients discontinued treatment during cycle 1. Most patients experienced AEs (94.2%) and ADRs (84.6%), and the most common serious ADR was capillary leak syndrome (22.1%). Effectiveness could be assessed in 80\/104 patients. The overall objective response rate was 16.3% (95% confidence interval: 8.9, 26.2), and in patients with PTCL and CTCL it was 15.4% (7.6, 26.5) and 20.0% (4.3, 48.1), respectively. Four patients (6.2%) with PTCL achieved a complete response.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This is the first observational study to evaluate the safety and effectiveness of DD\u2010cxdl in Japanese patients with relapsed or refractory PTCL and CTCL in daily clinical practice. No new safety concerns were identified. Clinicians should remain aware of the risk of capillary leak syndrome.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trail Registration:<\/jats:bold>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      identifier: NCT05137847 and Japan Registry of Clinical Trials identifier: jRCT2031220196.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cnr2.70641","type":"journal-article","created":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T04:41:11Z","timestamp":1786941671000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety and Effectiveness of Denileukin Diftitox\u2010cxdl in Patients With Relapsed\/Refractory Peripheral T\u2010Cell Lymphoma and Cutaneous T\u2010Cell Lymphoma: An All\u2010Case Post\u2010Marketing Study in Japan"],"prefix":"10.1002","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5415-6228","authenticated-orcid":false,"given":"Tatsuro","family":"Jo","sequence":"first","affiliation":[{"name":"Department of Hematology Japanese Red Cross Nagasaki Genbaku Hospital  Nagasaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kota","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Eisai Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mika","family":"Ishii","sequence":"additional","affiliation":[{"name":"Eisai Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"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":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,16]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11899\u2010016\u20100353\u2010y"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11899\u2010024\u201000727\u2010w"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12943\u2010023\u201001904\u2010w"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.27.7665"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11912\u2010023\u201001464\u20108"},{"key":"e_1_2_11_7_1","unstructured":"\u201cGuidelines for the Treatment of Hematopoietic Tumors Version 3.1 \u201d2024 In Japanese accessed 30 June 2026 http:\/\/www.jshem.or.jp\/gui\u2010hemali\/table.html."},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199304083281404"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.37.4223"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.29.9024"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2014.59.2782"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2006.10.2434"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.28.9066"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/protein\/1.6.493"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1084\/jem.167.2.612"},{"issue":"2","key":"e_1_2_11_16_1","first-page":"399","article-title":"Phase I Trial of a Ligand Fusion\u2010Protein (DAB389IL\u20102) in Lymphomas Expressing the Receptor for Interleukin\u20102","volume":"91","author":"LeMaistre C. 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