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      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

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          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 × 10 6/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 × 10 6/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 × 10 6/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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          Most cited references24

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          Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma.

          This phase 3, multicenter, randomized (1:1), double-blind, placebo-controlled study evaluated the safety and efficacy of plerixafor with granulocyte colony-stimulating factor (G-CSF) in mobilizing hematopoietic stem cells in patients with multiple myeloma. Patients received G-CSF (10 microg/kg) subcutaneously daily for up to 8 days. Beginning on day 4 and continuing daily for up to 4 days, patients received either plerixafor (240 microg/kg) or placebo subcutaneously. Starting on day 5, patients began daily apheresis for up to 4 days or until more than or equal to 6 x 10(6) CD34(+) cells/kg were collected. The primary endpoint was the percentage of patients who collected more than or equal to 6 x 10(6) CD34(+) cells/kg in less than or equal to 2 aphereses. A total of 106 of 148 (71.6%) patients in the plerixafor group and 53 of 154 (34.4%) patients in the placebo group met the primary endpoint (P < .001). A total of 54% of plerixafor-treated patients reached target after one apheresis, whereas 56% of the placebo-treated patients required 4 aphereses to reach target. The most common adverse events related to plerixafor were gastrointestinal disorders and injection site reactions. Plerixafor and G-CSF were well tolerated, and significantly more patients collected the optimal CD34(+) cell/kg target for transplantation earlier compared with G-CSF alone. This study is registered at www.clinicaltrials.gov as #NCT00103662.
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            Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma.

            This study evaluates the safety and efficacy of plerixafor (AMD3100), a CXCR4 antagonist, in mobilizing hematopoietic stem cells for autologous stem-cell transplantation in non-Hodgkin's lymphoma (NHL) patients. This is a phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study. Patients with non-Hodgkin's lymphoma requiring an autologous hematopoietic stem-cell transplantation in first or second complete or partial remission were eligible. Patients received granulocyte colony-stimulating factor (G-CSF; 10 microg/kg) subcutaneously daily for up to 8 days. Beginning on evening of day 4 and continuing daily for up to 4 days, patients received either plerixafor (240 microg/kg) or placebo subcutaneously. Starting on day 5, patients began daily apheresis for up to 4 days or until > or = 5 x 10(6) CD34+ cells/kg were collected. The primary end point was the percentage of patients who collected > or = 5 x 10(6) CD34+ cells/kg in 4 or fewer apheresis days. This report presents all data for all patients (n = 298) through 12 months follow-up. Eighty-nine (59%) of 150 patients in the plerixafor group and 29 (20%) of 148 patients in the placebo group met the primary end point (P < .001). One hundred thirty-five patients (90%) in plerixafor group and 82 patients (55%) in placebo group underwent transplantation after initial mobilization. Median time to engraftment was similar in both groups. The most common plerixafor-associated adverse events were GI disorders and injection site reactions. Plerixafor and G-CSF were well tolerated and resulted in a significantly higher proportion of patients with non-Hodgkin's lymphoma achieving the optimal CD34+ cell target for transplantation in fewer apheresis days, compared with G-CSF alone.
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              Optimizing autologous stem cell mobilization strategies to improve patient outcomes: consensus guidelines and recommendations.

              Autologous hematopoietic stem cell transplantation (aHSCT) is a well-established treatment for malignancies such as multiple myeloma (MM) and lymphomas. Various changes in the field over the past decade, including the frequent use of tandem aHSCT in MM, the advent of novel therapies for the treatment of MM and lymphoma, and the addition of new stem cell mobilization techniques, have led to the need to reassess current stem cell mobilization strategies. Mobilization failures with traditional strategies are common and result in delays in treatment and increased cost and resource utilization. Recently, plerixafor-containing strategies have been shown to significantly reduce mobilization failure rates, but the ideal method to maximize stem cell yields and minimize costs associated with collection has not yet been determined. A panel of experts convened to discuss the currently available data on autologous hematopoietic stem cell mobilization and transplantation and to devise guidelines to optimize mobilization strategies. Herein is a summary of their discussion and consensus.
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                Author and article information

                Contributors
                Journal
                Front Med (Lausanne)
                Front Med (Lausanne)
                Front. Med.
                Frontiers in Medicine
                Frontiers Media S.A.
                2296-858X
                02 February 2021
                2021
                : 8
                : 609116
                Affiliations
                [1] 1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute , Beijing, China
                [2] 2Department of Hematology, Henan Cancer Hospital , Zhengzhou, China
                [3] 3Department of Hematology, The First Medical Center, Chinese PLA General Hospital , Beijing, China
                [4] 4Department of Lymphoma, The Fifth Medical Center, Chinese PLA General Hospital , Beijing, China
                [5] 5Department of Hematology, Anhui Provincial Cancer Hospital , Hefei, China
                [6] 6Department of Lymphoma & Hematology, Jiangxi Cancer Hospital , Nanchang, China
                [7] 7Department of Hematology, First Affiliated Hospital of Jilin University , Changchun, China
                [8] 8Department of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College , Tianjin, China
                [9] 9Department of Hematology, Peking University Third Hospital , Beijing, China
                [10] 10Department of Hematology, Lanzhou University Second Hospital , Lanzhou, China
                [11] 11Department of Hematology, Tongji Medical College, Huazhong University of Science and Technology , Wuhan, China
                [12] 12Department of Hematology, The Fourth Hospital of Hebei Medical University , Shijiazhuang, China
                [13] 13Department of Hematology, Huai'an First People's Hospital, Nanjing Medical University , Huai'an, China
                [14] 14Department of Hematology, Beijing Hospital , Beijing, China
                [15] 15Department of Hematology, People's Hospital of Guangxi Zhuang Autonomous Region , Nanning, China
                [16] 16Department of Medical Statistics, Peking University First Hospital , Beijing, China
                [17] 17Peking University Clinical Research Institute , Beijing, China
                [18] 18Hefei Yifan Biopharmaceuticals Inc., Economic Development Zone , Hefei, China
                Author notes

                Edited by: Marcos De Lima, Case Western Reserve University, United States

                Reviewed by: Roland Schroers, Ruhr University Bochum, Germany; Esa Jantunen, University of Eastern Finland, Finland

                *Correspondence: Yuqin Song songyuqin@ 123456pkuih.edu.cn

                This article was submitted to Hematology, a section of the journal Frontiers in Medicine

                Article
                10.3389/fmed.2021.609116
                7884449
                8825e361-9319-4c99-b734-bd6c183006e5
                Copyright © 2021 Liu, Li, Wang, Su, Ding, Shuang, Gao, Zou, Jing, Chai, Zhang, Liu, Wang, Liu, Lin, Zhu, Yao, Yan, Shang, Wang, Chang, Wang, Zhu and Song.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 22 September 2020
                : 04 January 2021
                Page count
                Figures: 0, Tables: 4, Equations: 0, References: 24, Pages: 7, Words: 5236
                Categories
                Medicine
                Original Research

                hematopoietic stem cell mobilization,therapeutics,treatment outcome,safety,lymphoma,non-hodgkin

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