ObinutuzumabPhase 2NCT05510219
Safety Analysis of Intravenous Rapid Infusion of Obinutuzumab in Patients With B-cell Non-Hodgkin's Lymphoma in China
A Phase 2 study testing intravenous rapid infusion of obinutuzumab in people with Obinutuzumab and Rapid Infusion, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obinutuzumab, Rapid Infusion, Intravenous Infusion Reaction
- What is being tested?
- intravenous rapid infusion of obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
shuangshuang xing, +8613851784715, sryxss@163.com
About this study
Official title: Safety Analysis of Intravenous Rapid Infusion of Obinutuzumab in Patients With B-cell
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
- Being tested
- intravenous rapid infusion of obinutuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous rapid infusion of obinutuzumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous rapid infusion of obinutuzumab | Experimental | 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. Receives: Drug: intravenous rapid infusion of obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline infusion-related reactions at cycle 6
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
Measured: at the end of cycle 6(each cycle is 21~28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObinutuzumabStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JianYong Li, doctor, Study director, Jiangsu Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510219
- Sponsor's protocol ID
- 2022-SR-169
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Analysis of Intravenous Rapid Infusion of Obinutuzumab in Patients With B-cell
- ClinicalTrials.gov ID
- NCT05510219
- Acronym / sponsor ID
- 2022-SR-169
- Conditions
- Obinutuzumab, Rapid Infusion, Intravenous Infusion Reaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intravenous rapid infusion of obinutuzumab | Experimental | Drug: intravenous rapid infusion of obinutuzumabPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous rapid infusion of obinutuzumabThis 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. | Drug | Intravenous rapid infusion of obinutuzumab |
Primary outcome
change from baseline infusion-related reactions at cycle 6
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JianYong Li, doctor study director
Jiangsu Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intravenous rapid infusion of obinutuzumab in people with Obinutuzumab and Rapid Infusion, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shuangshuang xing, master (+8613851784715, sryxss@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline infusion-related reactions at cycle 6 (time frame: at the end of cycle 6(each cycle is 21~28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.