NCT05510219

Safety Analysis of Intravenous Rapid Infusion of Obinutuzumab in Patients With B-cell Non-Hodgkin's Lymphoma in China

Safety Analysis of Intravenous Rapid Infusion of Obinutuzumab in Patients With B-cell

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to analyze the safety of 90-min intravenous rapid infusion of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma and to provide evidence for the applicability of rapid infusion regimens in chemotherapy in China.

Conditions

• Obinutuzumab
• Rapid Infusion
• Intravenous Infusion Reaction

Interventions

Type	Name	Description
DRUG	intravenous rapid infusion of obinutuzumab	This study was a prospective, single-arm, open-label, phase IV clinical trial that included patients with B-cell non-Hodgkin's lymphoma who visited the Department of Hematology, Jiangsu Provincial People's Hospital. All patients were treated with the standard infusion regimen of obinutuzumab in cycle 1, and for patients who did not develop severe infusion-related reactions (IRRs) in cycle 1, a rapid 90-min obinutuzumab infusion regimen was used from cycle 2 onward while recording any occurrence of infusion reactions in different treatment cycles.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-08-22
• Last updated: 2022-08-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study