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

NCT05510219 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-08-22

No results posted yet for this study

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.

Conditions

  • Obinutuzumab
  • Rapid Infusion
  • Intravenous Infusion Reaction

Interventions

DRUG

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.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • JianYong Li, doctor · Jiangsu Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05510219 on ClinicalTrials.gov