Golidocitinib combined with CHOP in newly-diagnosed peripheral T-cell lymphoma: Preliminary Results from A phase 1/2 clinical trial

作者：Chong Wei, Wei Zhang, Daobin Zhou, Jian Li, Yan Zhang, Kaini Shen, Wei Wang, Zi Wang, Danqing Zhao, Jing Ruan, Huacong Cai, Yueying Mao · 发表于：Blood · 年份：2025 · DOI：10.1182/blood-2025-6322 · 被引用次数：1 · 研究领域：Lymphoma Diagnosis and Treatment、CNS Lymphoma Diagnosis and Treatment、Cutaneous lymphoproliferative disorders research

Abstract Background： Peripheral T-cell lymphoma (PTCL) comprises a group of heterogeneous and aggressive non-Hodgkin lymphomas associated with poor outcomes. CHOP remains the standard first-line therapy, yet the 5-year overall survival (OS) remains suboptimal. Golidocitinib, a potent and selective JAK1 inhibitor, has demonstrated promising anti-tumor activity with favorable safety profile in relapsed/refractory (r/r) PTCL. Aims： To evaluate the anti-tumor activity and tolerability of Golidocitinib in combination with CHOP regimen (Go-CHOP) as the frontline therapy for patients with PTCL. Methods： This is an ongoing phase 1/2, single-center, single-arm clinical trial (NCT06739265) evaluating Go-CHOP as first-line therapy in adults patients (≥18 years) with histologically confirmed, previously untreated PTCL, including PTCL-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large cell lymphoma (ALCL), etc. The study consists of two sequential phases: a 3+3 dose-escalation cohort (Phase 1) to determine the recommended phase 2 combination dose (RP2CD), followed by a dose-expansion cohort (Phase 2) assessing efficacy and safety. In Phase 1, patients receive six 21-day cycles of Go-CHOP: oral golidocitinib 150 mg every other day (Qod) on days 1-21 combined with standard CHOP chemotherapy (cyclophosphamide 750 mg/m², doxorubicin 50 mg/m², vincristine 1.4 mg/m² IV on day 1, and prednisone 100 mg po on days 1-5). Dose escalation to 150 mg onc...