Clinical trial · Interventional
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
NCT05510219CI-TRIAL-00060480unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intravenous Infusion Reaction | — | UNRESOLVED | — |
| Obinutuzumab | — | UNRESOLVED | — |
| Rapid Infusion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intravenous rapid infusion of obinutuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intravenous rapid infusion of obinutuzumab
- 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.
- interventionNames
- Drug: intravenous rapid infusion of obinutuzumab
Primary outcomes (1)
- measure
- change from baseline infusion-related reactions at cycle 6
- timeFrame
- at the end of cycle 6(each cycle is 21~28 days)
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.