{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T15:59:52Z","timestamp":1753891192113,"version":"3.41.2"},"reference-count":29,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,4,11]],"date-time":"2025-04-11T00:00:00Z","timestamp":1744329600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:p>The current first-line treatment for peripheral T-cell lymphoma (PTCL) has a typically poor prognosis. Developing a new regimen is urgently needed. This phase I study evaluated the maximum tolerated dose (MTD), safety, and efficacy of mitoxantrone hydrochloride liposome (Lipo-MIT) plus cyclophosphamide, vincristine, etoposide, and prednisone (COEP) in untreated PTCL. Patients with untreated PTCL were enrolled and received Lipo-MIT (15, 18, and 20 mg\/m<jats:sup>2<\/jats:sup>) following a 3 + 3 dose-escalation design plus standard doses of COEP (750 mg\/m<jats:sup>2<\/jats:sup> cyclophosphamide, 1.4 mg\/m<jats:sup>2<\/jats:sup> vincristine, 60 mg\/m<jats:sup>2<\/jats:sup> etoposide, and 100 mg prednisone) every 3 weeks for 6 cycles. Primary endpoint was MTD; secondary endpoints were safety, overall response rate (ORR), complete response (CR) rate, progression-free survival (PFS), and overall survival (OS). As of the cut-off date (October 29, 2024), 13 patients received the Lipo-MIT plus COEP (CMOEP) regimen. No patients experienced dose-limiting toxicities (DLT); MTD was 20 mg\/m<jats:sup>2<\/jats:sup> and the recommended phase 2 dose was 18 mg\/m<jats:sup>2<\/jats:sup>. Common \u2265grade 3 hematologic toxicities included neutrophil count decreased (76.9%), white blood cell decreased (76.9%), and lymphocyte count decreased (46.2%). Most common \u2265grade 3 non-hematologic toxicity was lung infection (15.4%). No deaths due to toxicities were reported. Among 12 patients evaluated for best response, ORR (95% CI, 73.5-100.0), and the CR rate was 66.7% (95% CI, 34.9-90.1). At a median follow-up of 8.5 months, the median PFS and OS were both not reached. The CMOEP regimen had a manageable safety profile and an encouraging clinical efficacy for PTCL patients, which warrants further investigation.<\/jats:p><jats:sec><jats:title>Clinical trial registration<\/jats:title><jats:p><jats:uri>ClinicalTrials.gov<\/jats:uri>, identifier NCT05458180.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fimmu.2025.1551723","type":"journal-article","created":{"date-parts":[[2025,4,11]],"date-time":"2025-04-11T05:14:09Z","timestamp":1744348449000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["CMOEP regimen in the treatment of untreated peripheral T-cell lymphoma: a multicenter, single-arm, phase I study"],"prefix":"10.3389","volume":"16","author":[{"given":"Jingwei","family":"Yu","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiuhua","family":"Sun","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guangxun","family":"Gao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"Yu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiesong","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lihua","family":"Qiu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhengzi","family":"Qian","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Li","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huilai","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2025,4,11]]},"reference":[{"volume-title":"WHO 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