Intravenous Infusion Reaction, Obinutuzumab, Rapid Infusion
Conditions
Brief 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.
Interventions
DRUGintravenous 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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline infusion-related reactions at cycle 6 | at the end of cycle 6(each cycle is 21~28 days) | 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 |
Countries
China
Contacts
Primary Contactshuangshuang xing, master
Outcome results
None listed