A phase II trial to assess the efficacy and safety of ropeginterferon α-2b in Chinese patients with polycythemia vera

作者：Jie Jin, Albert Qin, Lei Zhang, Weihong Shen, Wei Wang, Jingjing Zhang, Yaning Li, Daoxiang Wu, Zhijian Xiao · 发表于：Future Oncology · 年份：2023 · DOI：10.2217/fon-2022-1141 · 被引用次数：13 · 研究领域：Myeloproliferative Neoplasms: Diagnosis and Treatment、Eosinophilic Disorders and Syndromes、Hemoglobinopathies and Related Disorders

Ropeginterferon α-2b is a mono-PEGylated proline-interferon for the treatment of polycythemia vera. This drug is used biweekly with a starting dose of 100 μg (50 μg if patients receiving hydroxyurea) and 50 μg increments up to a maximum dose of 500 μg. Increasing evidence indicates that patients can tolerate higher starting doses of ropeginterferon α-2b. This phase II trial utilizes 250 μg as the starting dose, 350 μg at week 2 and 500 μg at week 4 as the target dose. Doses can be adjusted according to tolerability. This study assesses the safety, efficacy and molecular response of ropeginterferon α-2b in Chinese patients with PV utilizing the 250-350-500 μg dosing schema. This study will be used to support the application of a biologics license for polycythemia vera treatment in China.