Mascarenhas John, Bose Prithviraj, Hillis Christopher, Yacoub Abdulraheem, El Chaer Firas, Maze Dawn, Abu-Zeinah Ghaith, Qin Albert, Priego Victor, Tashi Tsewang, Cerquozzi Sonia, Babu Sunil, Foltz Lynda, Goel Swati, Bhave Rupali R, Lee Stephanie, Oh Stephen T, Reeves Brandi, Benton Christopher, Fletcher Luke, Sirhan Shireen, Safah Hana, Salib Hayman, Villeneuve Pierre J A, Zagrijtschuk Oleh, Castro Henry, Masarova Lucia
Tisch Cancer Institute, Division of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Division of Cancer Medicine, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Acta Haematol. 2025 Mar 5:1-7. doi: 10.1159/000544818.
Ropeginterferon alfa-2b-njft (ropeg) was approved and recommended as a preferred cytoreductive treatment for polycythemia vera (PV). The approved regimen requires an initial dose of 100 μg or 50 μg if transitioning from hydroxyurea (HU) and up-titrations of 50 μg every 2 weeks to 500 μg maximumly. The time to achieve the plateau dose takes approximately 20 weeks. This study compares the approved regimen with a higher initial dose and accelerated dose titration (HIDAT) regimen.
ECLIPSE-PV is a randomized, open-label, multicenter trial in patients with PV in the USA and Canada. Patients received ropeg either per the approved dosing schema or HIDAT regimen, i.e., 250 μg on day 0, 350 μg at week 2, and 500 μg from week 4 thereafter if tolerable. The primary endpoint is complete hematologic response (CHR) rate at week 24. CHR is defined as hematocrit <45%, white blood cells <10 × 109/L, platelets ≤400 × 109/L without phlebotomy in the previous 12 weeks. Secondary endpoints include molecular response, safety, tolerability, and quality of life.
A total of 111 patients were randomized and the last patient was enrolled on June 21, 2024. As of November 12, 2024, the discontinuation rate was 14.4%, and 16 patients (14.4%) completed the study. The study is expected to be completed in the summer of 2025. This is the first prospective trial comparing two dosing regimens of ropeg. The results will inform the optimal treatment strategy for patients with PV.
聚乙二醇干扰素α-2b-njft（ropeg）已获批准并被推荐为真性红细胞增多症（PV）的首选细胞减灭治疗药物。批准的方案要求初始剂量为100μg；若从羟基脲（HU）转换，则初始剂量为50μg，每2周递增50μg，最大剂量为500μg。达到平台剂量的时间约为20周。本研究将批准的方案与更高初始剂量和加速剂量滴定（HIDAT）方案进行比较。
ECLIPSE-PV是一项在美国和加拿大针对PV患者的随机、开放标签、多中心试验。患者按照批准的给药方案或HIDAT方案接受ropeg治疗，即第0天250μg，第2周350μg，此后若耐受，从第4周起为500μg。主要终点是第24周时的完全血液学缓解（CHR）率。CHR定义为血细胞比容<45%、白细胞<10×10⁹/L、血小板≤400×10⁹/L，且在过去12周内未进行放血治疗。次要终点包括分子反应、安全性、耐受性和生活质量。
共有111例患者被随机分组，并于2024年6月21日纳入最后1例患者。截至2024年11月12日，停药率为14.4%，16例患者（14.4%）完成了研究。该研究预计于2025年夏季完成。这是第一项比较ropeg两种给药方案的前瞻性试验。结果将为PV患者的最佳治疗策略提供依据。
