Weiping Liu1, Yufu Li2, Quanshun Wang3, Hang Su4, Kaiyang Ding5, Yuerong Shuang6, Sujun Gao7, Dehui Zou8, Hongmei Jing9, Ye Chai10, Yicheng Zhang11, Lihong Liu12, Chunling Wang13, Hui Liu14, Jinying Lin15, Haiyan Zhu3, Chen Yao16, Xiaoyan Yan17, Meixia Shang16, Shufang Wang18, Fengyuan Chang18, Xiaopei Wang1, Jun Zhu1, Yuqin Song1. 1. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China. 2. Department of Hematology, Henan Cancer Hospital, Zhengzhou, China. 3. Department of Hematology, The First Medical Center, Chinese PLA General Hospital, Beijing, China. 4. Department of Lymphoma, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China. 5. Department of Hematology, Anhui Provincial Cancer Hospital, Hefei, China. 6. Department of Lymphoma & Hematology, Jiangxi Cancer Hospital, Nanchang, China. 7. Department of Hematology, First Affiliated Hospital of Jilin University, Changchun, China. 8. Department of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China. 9. Department of Hematology, Peking University Third Hospital, Beijing, China. 10. Department of Hematology, Lanzhou University Second Hospital, Lanzhou, China. 11. Department of Hematology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 12. Department of Hematology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. 13. Department of Hematology, Huai'an First People's Hospital, Nanjing Medical University, Huai'an, China. 14. Department of Hematology, Beijing Hospital, Beijing, China. 15. Department of Hematology, People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China. 16. Department of Medical Statistics, Peking University First Hospital, Beijing, China. 17. Peking University Clinical Research Institute, Beijing, China. 18. Hefei Yifan Biopharmaceuticals Inc., Economic Development Zone, Hefei, China.
Abstract
Background: YF-H-2015005, a novel CXCR4 antagonist, has been proven to increase the quantities of circulating hematopoietic stem cells (HSCs), which results in an adequate collection of HSCs in non-Hodgkin lymphoma (NHL) patients. Methods: This was a multicenter, double-blind, randomized (1:1), placebo-controlled phase III clinical trial. All patients received granulocyte colony-stimulating factor (G-CSF) for up to 8 consecutive days. YF-H-2015005 or placebo was administrated on the evening of day 4 and continued daily for up to 4 days. Apheresis was conducted 9-10 h after each dose of YF-H-2015005 or placebo. The primary endpoint was the proportion of NHL patients procuring ≥5 × 106/kg CD34+ HSCs within ≤4 apheresis sessions. Results: In total, 101 patients with NHL were enrolled. The proportions of patients achieving primary endpoint were 57 and 12% in YF-H-2015005 and placebo groups, respectively (P < 0.001). Moreover, a higher proportion of YF-H-2015005-treated patients reached a minimum target collection of ≥2 × 106/kg CD34+ HSCs in ≤4 apheresis days compared to placebo-treated patients (86 vs. 38%, P < 0.001). Furthermore, the median time to collect ≥2 or 5 × 106/kg CD34+ HSCs were 1 and 3 days in YF-H-2015005-treated patients, but 4 days and not reached in placebo-treated patients, respectively. No severe treatment emergent adverse events were observed in both YF-H-2015005 treatment and placebo groups. Conclusions: YF-H-2015005 plus G-CSF regimen was a tolerable combination with high efficacy, which might be used to rapidly mobilize and collect HSCs in NHL patients.
RCT Entities:
Background: YF-H-2015005, a novel CXCR4 antagonist, has been proven to increase the quantities of circulating hematopoietic stem cells (HSCs), which results in an adequate collection of HSCs in non-Hodgkin lymphoma (NHL) patients. Methods: This was a multicenter, double-blind, randomized (1:1), placebo-controlled phase III clinical trial. All patients received granulocyte colony-stimulating factor (G-CSF) for up to 8 consecutive days. YF-H-2015005 or placebo was administrated on the evening of day 4 and continued daily for up to 4 days. Apheresis was conducted 9-10 h after each dose of YF-H-2015005 or placebo. The primary endpoint was the proportion of NHL patients procuring ≥5 × 106/kg CD34+ HSCs within ≤4 apheresis sessions. Results: In total, 101 patients with NHL were enrolled. The proportions of patients achieving primary endpoint were 57 and 12% in YF-H-2015005 and placebo groups, respectively (P < 0.001). Moreover, a higher proportion of YF-H-2015005-treated patients reached a minimum target collection of ≥2 × 106/kg CD34+ HSCs in ≤4 apheresis days compared to placebo-treated patients (86 vs. 38%, P < 0.001). Furthermore, the median time to collect ≥2 or 5 × 106/kg CD34+ HSCs were 1 and 3 days in YF-H-2015005-treated patients, but 4 days and not reached in placebo-treated patients, respectively. No severe treatment emergent adverse events were observed in both YF-H-2015005 treatment and placebo groups. Conclusions: YF-H-2015005 plus G-CSF regimen was a tolerable combination with high efficacy, which might be used to rapidly mobilize and collect HSCs in NHL patients.
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