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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obinutuzumab, Rapid Infusion, Intravenous Infusion Reaction

Intervention / Treatment
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* Drug: intravenous rapid infusion of obinutuzumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous rapid infusion of obinutuzumab<br>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. | Drug: intravenous rapid infusion of obinutuzumab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline infusion-related reactions at cycle 6 | The severity of an IRR was graded according to the Common Terminology Criteria for Adverse Events ver 5.0 published by the National Cancer Institute | at the end of cycle 6(each cycle is 21 28 days) |