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

Nanjing Medical University

Status and phase: Enrolling; Phase 2

Conditions: Rapid Infusion; Obinutuzumab; Intravenous Infusion Reaction

Treatments: Drug: intravenous rapid infusion of obinutuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05510219

2022-SR-169

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of B-cell lymphoma and with indications for obinutuzumab treatment
• No significant organ damage
• ECOG score of 0-2;
• Life expectancy ≥ 6 months
• Informed consent

Exclusion criteria

• Pregnant or lactating
• Serologically tested positive for human immunodeficiency virus or hepatitis B virus infection but had not received treatment
• Severe hepatic or renal insufficiency
• Severe cardiovascular disease.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Intravenous rapid infusion of obinutuzumab

Experimental group

Description:

Patients with B-cell non-Hodgkin's lymphoma were treated with the standard infusion regimen of obinutuzumab in cycle 1, and for patients who did not develop severe infusion-related reactions 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.

Treatment:

Drug: intravenous rapid infusion of obinutuzumab