Safety Analysis of Intravenous Rapid Infusion of Obinutuzumab in Patients With B-cell Non-Hodgkin's Lymphoma in China
NCT ID: NCT05510219
Last Updated: 2022-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2022-01-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intravenous rapid infusion of obinutuzumab
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* No significant organ damage
* ECOG score of 0-2;
* Life expectancy ≥ 6 months
* Informed consent
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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JianYong Li, doctor
Role: STUDY_DIRECTOR
Jiangsu Provincial People's Hospital
Locations
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Jiangsu Province Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-SR-169
Identifier Type: -
Identifier Source: org_study_id
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