Safety of a 90-min duration of intravenous infusion of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma in a tertiary hospital in China: a prospective, open-label, exploratory clinical trial

Autor: Shuangshuang Xing, Yiqin Pu, Xiaoqian Zhao, Yan Hu, Feiyan Zhang, Zejuan Gu, Wei Xu, Lei Fan, Yi Miao, Jianyong Li
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Brazilian Journal of Medical and Biological Research, Vol 57 (2024)
Druh dokumentu: article
ISSN: 1414-431X
1414-431x
DOI: 10.1590/1414-431x2023e13284
Popis: This study aimed to analyze the safety and applicability of a 90-min duration of infusion (SDI) of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma (NHL) in a tertiary hospital in China. This exploratory clinical trial was performed at Jiangsu Province Hospital. All patients were treated with the standard infusion regimen for the first infusion. If no grade ≥3 infusion-related reactions (IRRs) occurred, the subsequent infusions were given as SDI. The primary endpoint was the incidence of IRR during the standard infusion (3-4 h) and 90-min SDI regimens. This study enrolled 208 patients and all completed cycle 1. Forty-one patients (19.71%) had IRRs: five (2.40%) with grade 1, twenty-eight (13.46%) with grade 2, and eight (3.85%) with grade 3. The 41 patients had 71 IRRs, mainly fever (40.85%), chest pain/tightness (12.68%), and dyspnea (9.86%). The occurrence of IRRs in the first infusion was significantly lower in patients who received oral acetaminophen prophylaxis than those who did not (10.72% vs 30.21%, P
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