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A Single-Arm, Multicenter, Phase II Study of Camrelizumab in Relapsed or Refractory Classical Hodgkin Lymphoma

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机构: [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China. [2]Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China. [3]Department of Hematology, West China Hospital, Sichuan University, Chengdu, China. [4]Department of Medical Oncology, Sun Yat-sen University Cancer Centre, Guangzhou, China. [5]Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. [6]Lymphatic Comprehensive Internal Medicine Ward, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. [7]Lymphoma Clinic, Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjing, China. [8]Department of Hematology, The First Affiliated Hospital, Zhejiang University, Hangzhou, China. [9]Department ofHematology, The First AffiliatedHospital of Soochow University, Suzhou, China. [10]Department of Hematology, Fujian Medical University Union Hospital, Fuzhou, China. [11]Department of Hematology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China. [12]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [13]Department of Hematology, The Affiliated Hospital of Qingdao University, Qingdao, China. [14]Department of Oncology, Cancer Hospital Harbin Medical University, Harbin, China. [15]Department of Oncology, Jiangsu Hengrui Medicine Co. Ltd, Shanghai, China. [16]Department of Clinical Statistics and Programming, Jiangsu Hengrui Medicine Co. Ltd, Shanghai, China.
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Purpose: For classical Hodgkin lymphoma (cHL), programmed death-l (PD-1) is a well-recognized attractive target. This multicenter, single-arm, phase II study evaluated the efficacy and safety of camrelizumab, a humanized high-affinity IgG4 mAb against PD-1, in Chinese patients with relapsed or refractory cHL. Patients and Methods: Patients who had failed to achieve a remission or experienced progression after autologous stem cell transplantation or had received at least two lines of systemic chemotherapies were given camrelizumab 200 mg every 2 weeks. The primary endpoint was objective response rate per independent review committee (IRC) assessment. This study is registered with ClinicalTrials.gov (NCT03155425). Results: Between June 9, 2017 and September 18, 2017, 75 patients were enrolled and treated. At a median follow-up of 12.9 months, 57 of 75 (76.0%; 95% CI, 64.7-85.1) patients achieved an IRC-assessed objective response, including 21 (28.0%) and 36 (48.0%) patients who had complete and partial remission, respectively. Median duration of response was not reached (range, 0.0(+) - 12.8(+) months). Treatment-related adverse events (AE) occurred in all patients. The most common ones included cutaneous reactive capillary endothelial proliferation (97.3%, 73/75) and pyrexia (42.7%, 32/75). Grade 3 or 4 treatment-related AEs occurred in 20 patients (26.7%); the most common AE was decreased white blood cell count (4.0%, 3/75). There were no grade 5 treatment-related AEs. Conclusions: Camrelizumab demonstrated a high response rate, durable response and controllable safety in Chinese patients with relapsed or refractory cHL, becoming a new safe and effective treatment option in this setting.

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出版当年[2019]版:
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2023]版:
大类 | 1 区 医学
小类 | 1 区 肿瘤学
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Q1 ONCOLOGY
最新[2023]版:
Q1 ONCOLOGY

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第一作者机构: [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China.
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通讯机构: [1]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China. [2]Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China. [*1]Peking University Cancer Hospital & Institute, No. 52, Fucheng Road, Haidian District, Beijing 100142, China. [*2]Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research &Nanjing Medical University Affiliated Cancer Hospital, No. 42, Baiziting, Nanjing 210029, China.
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