Lymphomas Non-Hodgkin's B-CellNCT05968001
Obinutuzumab in Chinese Real-world Patients With iNHL
An observational study of Lymphomas Non-Hodgkin's B-Cell, run by Affiliated Hospital of Nantong University at 25 sites in China.
Trial summary
This study aims to assess the clinical efficacy and safety of obinutuzumab in Chinese patients with indolent non-Hodgkin B-cell Lymphoma (predominantly Follicular lymphoma and Marginal zone lymphoma) in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphomas Non-Hodgkin's B-Cell
- What is being tested?
- Obinutuzumab
- How many people
- 400 participants
- Where
- 25 sitesChina
- Study dates
- 20 Jul 2023to 20 Jul 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with FL and MZL who started treatment with otuzumab between June 2021 and April 2023.
Who may be able to join
- Age: Age ≥ 18 years at the start of treatment;
- Be diagnosed with grade 1-3a follicular Lymphoma, Marginal zone lymphoma;
- Previously untreated or relapsed or refractory patients;
- Patients who started treatment with otuzumab between June 2021 and April 2023.
Who cannot join
- Patients currently participating or planning to participate in any interventional clinical trial;
- Patients who, in the opinion of the investigator, are Discomfort for any other reason to participate in this study.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Changzhou No.2 People's Hospital
Changzhou, Jiangsu
Xuzhang Lu, PhD
The First People's hospital of Changzhou
Changzhou, Jiangsu
Weiying Gu, PhD
Huai'an First People's hospital
Huai'an, Jiangsu
Liang Yu, PhD
Jiangyin People's Hospital
Jiangyin, Jiangsu
Maozhong Xu, PhD
Maozhong Xu, PhD
Jingjiang People's Hospital
Jingjiang, Jiangsu
Miao Sun, PhD
The first people's hospital of Lianyungang
Lianyungang, Jiangsu
Tao Jia, PhD
The second people's hospital of Lianyungang
Lianyungang, Jiangsu
Wanchuan Zhuang, PhD
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu
Haiwen Ni, PhD
Jiangsu Province Hospital
Nanjing, Jiangsu
Jianyong Li, PhD
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Nanjing Jiangning Hospital
Nanjing, Jiangsu
Jinning Shi, PhD
Nantong Tumor Hospital
Nantong, Jiangsu
Xiaohong Xu, PhD
Affiliated Hospital of Nantong University
Nanyang, Jiangsu
Wenyu Shi, PhD, +86 13515203737, shiwenyu@hotmail.com
Wenyu Shi, PhD
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Bingzong Li, PhD
Jiangsu Taizhou People's Hospital
Taizhou, Jiangsu
Jianfeng Zhu, PhD
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu
Haiying Hua, PhD
Wuxi People's Hospital
Wuxi, Jiangsu
Yun Zhuang, PhD
Wuxi Second People's Hospital
Wuxi, Jiangsu
Zhi Wang, PhD
Zhi Wang, PhD
Yancheng No.1 People's Hospital
Yancheng, Jiangsu
Yuexin Cheng, PhD
Yuexin Cheng, PhD
Yancheng Third People's Hospital
Yancheng, Jiangsu
Naitong Sun, PhD
Subei People's Hospital
Yangzhou, Jiangsu
Xiaoyan Xie, PhD
Yixing People's Hospital
Yixing, Jiangsu
Yunping Zhang, PhD
Zhangjiagang First People's Hospital
Zhangjiagang, Jiangsu
Min Xu, PhD
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
Xiaoming Fei, PhD
Zhenjiang First People's Hospital
Zhenjiang, Jiangsu
Jun Qian, PhD
About this study
Official title: Efficacy and Safety of Obinutuzumab in Chinese Patients With Indolent Non-Hodgkin's B-cell Lymphoma in the Real-World.
This study aims to assess the clinical efficacy and safety of obinutuzumab in Chinese patients with indolent non-Hodgkin B-cell Lymphoma (predominantly Follicular lymphoma and Marginal zone lymphoma) in a real-world setting.
Read the detailed description
This study was a prospective, multicenter, non-interventional, real-world study. The study will be divided into two cohorts: Cohort 1 is the younger cohort (aged ≥ 18 and < 60 years at the start of treatment); Cohort 2 is the older cohort (aged ≥ 60 years at the start of treatment). Patients in this study will receive obinutuzumab-contained regimens according to the investigators' clinical opinion.
- Conditions
- Lymphomas Non-Hodgkin's B-Cell
- Being tested
- Obinutuzumab
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | the younger cohort (aged ≥ 18 and < 60 years at the start of treatment) Receives: Drug: Obinutuzumab | |
| Cohort 2 | the older cohort (aged ≥ 60 years at the start of treatment) Receives: Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoints
The best objective response rate (ORR), and CR rate; ORR and CR rate at the end of treatment; DCR, DoR, TTNT, PFS, DFS, and OS.
Measured: 12 months
Secondary outcomes (1)
Safety Endpoints
All AEs, SAEs, Grade 3 AEs, and all other safety variables, including vital signs, Physical examination results, and laboratory parameters.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start20 Jul 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphomas Non-Hodgkin's B-CellStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenyu Shi, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968001
- Sponsor's protocol ID
- JCLG-23-04
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Obinutuzumab in Chinese Patients With Indolent Non-Hodgkin's B-cell Lymphoma in the Real-World.
- ClinicalTrials.gov ID
- NCT05968001
- Acronym / sponsor ID
- JCLG-23-04
- Conditions
- Lymphomas Non-Hodgkin's B-Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 1 Aug 2023 (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 aims to assess the clinical efficacy and safety of obinutuzumab in Chinese patients with indolent non-Hodgkin B-cell Lymphoma (predominantly Follicular lymphoma and Marginal zone lymphoma) in a real-world setting.
Detailed description
This study was a prospective, multicenter, non-interventional, real-world study. The study will be divided into two cohorts: Cohort 1 is the younger cohort (aged ≥ 18 and < 60 years at the start of treatment); Cohort 2 is the older cohort (aged ≥ 60 years at the start of treatment). Patients in this study will receive obinutuzumab-contained regimens according to the investigators' clinical opinion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Obinutuzumabthe younger cohort (aged ≥ 18 and < 60 years at the start of treatment) |
| Cohort 2 | – | Drug: Obinutuzumabthe older cohort (aged ≥ 60 years at the start of treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with FL and MZL who started treatment with otuzumab between June 2021 and April 2023.
Key inclusion criteria (4 listed)
- Age: Age ≥ 18 years at the start of treatment;
- Be diagnosed with grade 1-3a follicular Lymphoma, Marginal zone lymphoma;
- Previously untreated or relapsed or refractory patients;
- Patients who started treatment with otuzumab between June 2021 and April 2023.
Key exclusion criteria (2 listed)
- Patients currently participating or planning to participate in any interventional clinical trial;
- Patients who, in the opinion of the investigator, are Discomfort for any other reason to participate in this study.
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 |
|---|---|---|
| Obinutuzumabobinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Efficacy Endpoints
Time frame: 12 months
The best objective response rate (ORR), and CR rate; ORR and CR rate at the end of treatment; DCR, DoR, TTNT, PFS, DFS, and OS.
1 secondary outcome
Safety Endpoints
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphomas Non-Hodgkin's B-Cell, run by Affiliated Hospital of Nantong University at 25 sites 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 4 inclusion and 2 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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.
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 Wenyu Shi, PhD (+86 13515203737, shiwenyu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Endpoints (time frame: 12 months). 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 1 Aug 2023.