Artikel ; Online: 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.
2024 Band 57, Seite(n) e13284
Abstract: 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 ...
| Abstract | 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<0.001). For the subsequent cycles with 90-min SDI, only two (0.25%) IRRs occurred among 814 infusions (one grade 1 hand numbness and one grade 2 chill/fever). The 90-min obinutuzumab SDI might be safe and feasible in patients with B-cell NHL in China. |
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| Mesh-Begriff(e) | Humans ; Antibodies, Monoclonal, Humanized ; Infusions, Intravenous ; Lymphoma, Non-Hodgkin/drug therapy ; Prospective Studies ; Tertiary Care Centers | |||||
| Chemische Substanzen | Antibodies, Monoclonal, Humanized ; obinutuzumab (O43472U9X8) | |||||
| Sprache | Englisch | |||||
| Erscheinungsdatum | 2024-02-09 | |||||
| Erscheinungsland | Brazil | |||||
| Dokumenttyp | Clinical Trial ; Journal Article | |||||
| ZDB-ID | 786234-9 | |||||
| ISSN | 1414-431X ; 0100-879X | |||||
| ISSN (online) | 1414-431X | |||||
| ISSN | 0100-879X | |||||
| DOI | 10.1590/1414-431X2023e13284 | |||||
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| Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
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