YF-H-2015005, a CXCR4 Antagonist, for the Mobilization of Hematopoietic Stem Cells in Non-Hodgkin Lymphoma Patients: A Randomized, Controlled, Phase 3 Clinical Trial

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), place...

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Main Authors: Weiping Liu, Yufu Li, Quanshun Wang, Hang Su, Kaiyang Ding, Yuerong Shuang, Sujun Gao, Dehui Zou, Hongmei Jing, Ye Chai, Yicheng Zhang, Lihong Liu, Chunling Wang, Hui Liu, Jinying Lin, Haiyan Zhu, Chen Yao, Xiaoyan Yan, Meixia Shang, Shufang Wang, Fengyuan Chang, Xiaopei Wang, Jun Zhu, Yuqin Song
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-02-01
Series:Frontiers in Medicine
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2021.609116/full
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author Weiping Liu
Yufu Li
Quanshun Wang
Hang Su
Kaiyang Ding
Yuerong Shuang
Sujun Gao
Dehui Zou
Hongmei Jing
Ye Chai
Yicheng Zhang
Lihong Liu
Chunling Wang
Hui Liu
Jinying Lin
Haiyan Zhu
Chen Yao
Xiaoyan Yan
Meixia Shang
Shufang Wang
Fengyuan Chang
Xiaopei Wang
Jun Zhu
Yuqin Song
author_facet Weiping Liu
Yufu Li
Quanshun Wang
Hang Su
Kaiyang Ding
Yuerong Shuang
Sujun Gao
Dehui Zou
Hongmei Jing
Ye Chai
Yicheng Zhang
Lihong Liu
Chunling Wang
Hui Liu
Jinying Lin
Haiyan Zhu
Chen Yao
Xiaoyan Yan
Meixia Shang
Shufang Wang
Fengyuan Chang
Xiaopei Wang
Jun Zhu
Yuqin Song
author_sort Weiping Liu
collection DOAJ
description 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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spelling doaj.art-6b5b3c0532544266b1d5c5abd5e8098b2022-12-21T22:49:02ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2021-02-01810.3389/fmed.2021.609116609116YF-H-2015005, a CXCR4 Antagonist, for the Mobilization of Hematopoietic Stem Cells in Non-Hodgkin Lymphoma Patients: A Randomized, Controlled, Phase 3 Clinical TrialWeiping Liu0Yufu Li1Quanshun Wang2Hang Su3Kaiyang Ding4Yuerong Shuang5Sujun Gao6Dehui Zou7Hongmei Jing8Ye Chai9Yicheng Zhang10Lihong Liu11Chunling Wang12Hui Liu13Jinying Lin14Haiyan Zhu15Chen Yao16Xiaoyan Yan17Meixia Shang18Shufang Wang19Fengyuan Chang20Xiaopei Wang21Jun Zhu22Yuqin Song23Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, ChinaDepartment of Hematology, Henan Cancer Hospital, Zhengzhou, ChinaDepartment of Hematology, The First Medical Center, Chinese PLA General Hospital, Beijing, ChinaDepartment of Lymphoma, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, ChinaDepartment of Hematology, Anhui Provincial Cancer Hospital, Hefei, ChinaDepartment of Lymphoma & Hematology, Jiangxi Cancer Hospital, Nanchang, ChinaDepartment of Hematology, First Affiliated Hospital of Jilin University, Changchun, ChinaDepartment of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, ChinaDepartment of Hematology, Peking University Third Hospital, Beijing, China0Department of Hematology, Lanzhou University Second Hospital, Lanzhou, China1Department of Hematology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China2Department of Hematology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China3Department of Hematology, Huai'an First People's Hospital, Nanjing Medical University, Huai'an, China4Department of Hematology, Beijing Hospital, Beijing, China5Department of Hematology, People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, ChinaDepartment of Hematology, The First Medical Center, Chinese PLA General Hospital, Beijing, China6Department of Medical Statistics, Peking University First Hospital, Beijing, China7Peking University Clinical Research Institute, Beijing, China6Department of Medical Statistics, Peking University First Hospital, Beijing, China8Hefei Yifan Biopharmaceuticals Inc., Economic Development Zone, Hefei, China8Hefei Yifan Biopharmaceuticals Inc., Economic Development Zone, Hefei, ChinaKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, ChinaKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, ChinaKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, ChinaBackground: 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.https://www.frontiersin.org/articles/10.3389/fmed.2021.609116/fullhematopoietic stem cell mobilizationtherapeuticstreatment outcomesafetylymphomanon-Hodgkin
spellingShingle Weiping Liu
Yufu Li
Quanshun Wang
Hang Su
Kaiyang Ding
Yuerong Shuang
Sujun Gao
Dehui Zou
Hongmei Jing
Ye Chai
Yicheng Zhang
Lihong Liu
Chunling Wang
Hui Liu
Jinying Lin
Haiyan Zhu
Chen Yao
Xiaoyan Yan
Meixia Shang
Shufang Wang
Fengyuan Chang
Xiaopei Wang
Jun Zhu
Yuqin Song
YF-H-2015005, a CXCR4 Antagonist, for the Mobilization of Hematopoietic Stem Cells in Non-Hodgkin Lymphoma Patients: A Randomized, Controlled, Phase 3 Clinical Trial
Frontiers in Medicine
hematopoietic stem cell mobilization
therapeutics
treatment outcome
safety
lymphoma
non-Hodgkin
title YF-H-2015005, a CXCR4 Antagonist, for the Mobilization of Hematopoietic Stem Cells in Non-Hodgkin Lymphoma Patients: A Randomized, Controlled, Phase 3 Clinical Trial
title_full YF-H-2015005, a CXCR4 Antagonist, for the Mobilization of Hematopoietic Stem Cells in Non-Hodgkin Lymphoma Patients: A Randomized, Controlled, Phase 3 Clinical Trial
title_fullStr YF-H-2015005, a CXCR4 Antagonist, for the Mobilization of Hematopoietic Stem Cells in Non-Hodgkin Lymphoma Patients: A Randomized, Controlled, Phase 3 Clinical Trial
title_full_unstemmed YF-H-2015005, a CXCR4 Antagonist, for the Mobilization of Hematopoietic Stem Cells in Non-Hodgkin Lymphoma Patients: A Randomized, Controlled, Phase 3 Clinical Trial
title_short YF-H-2015005, a CXCR4 Antagonist, for the Mobilization of Hematopoietic Stem Cells in Non-Hodgkin Lymphoma Patients: A Randomized, Controlled, Phase 3 Clinical Trial
title_sort yf h 2015005 a cxcr4 antagonist for the mobilization of hematopoietic stem cells in non hodgkin lymphoma patients a randomized controlled phase 3 clinical trial
topic hematopoietic stem cell mobilization
therapeutics
treatment outcome
safety
lymphoma
non-Hodgkin
url https://www.frontiersin.org/articles/10.3389/fmed.2021.609116/full
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