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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05510219

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obinutuzumab Rapid Infusion Intravenous Infusion Reaction	Drug: intravenous rapid infusion of obinutuzumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: intravenous rapid infusion of obinutuzumab

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiangsu Province Hospital	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

The First Affiliated Hospital with Nanjing Medical University

Investigators

Study Director: JianYong Li, doctor, Jiangsu Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT05510219

Other Study ID Numbers:

2022-SR-169

First Posted:

Aug 22, 2022

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Obinutuzumab

Study Results

No Results Posted as of Aug 22, 2022