| Autor: |
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 |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
|
| Zdroj: |
Frontiers in Medicine, Vol 8 (2021) |
| Druh dokumentu: |
article |
| ISSN: |
2296-858X |
| DOI: |
10.3389/fmed.2021.609116 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
|
