Obinutuzumab in Chinese Real-world Patients With iNHL

July 23, 2023 updated by: Wenyu Shi, Affiliated Hospital of Nantong University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China
        • Changzhou No.2 People's Hospital
        • Contact:
          • Xuzhang Lu, PhD
      • Changzhou, Jiangsu, China
        • The First People's Hospital of Changzhou
        • Contact:
          • Weiying Gu, PhD
      • Huai'an, Jiangsu, China
        • Huai'an first people's hospital
        • Contact:
          • Liang Yu, PhD
      • Jiangyin, Jiangsu, China
        • Jiangyin People's Hospital
        • Contact:
          • Maozhong Xu, PhD
        • Principal Investigator:
          • Maozhong Xu, PhD
        • Sub-Investigator:
          • Xi Xu, PhD
      • Jingjiang, Jiangsu, China
        • Jingjiang People's Hospital
        • Contact:
          • Miao Sun, PhD
      • Lianyungang, Jiangsu, China
        • The first people's hospital of Lianyungang
        • Contact:
          • Tao Jia, PhD
      • Lianyungang, Jiangsu, China
        • The Second People's Hospital of Lianyungang
        • Contact:
          • Wanchuan Zhuang, PhD
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
        • Contact:
          • Jianyong Li, PhD
      • Nanjing, Jiangsu, China
        • Nanjing Jiangning Hospital
        • Contact:
          • Jinning Shi, PhD
      • Nanjing, Jiangsu, China
        • Nanjing Drum Tower Hospital
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital of Chinese Medicine
        • Contact:
          • Haiwen Ni, PhD
      • Nantong, Jiangsu, China
        • Nantong Tumor Hospital
        • Contact:
          • Xiaohong Xu, PhD
      • Nanyang, Jiangsu, China
        • Affiliated Hospital of Nantong University
        • Contact:
        • Principal Investigator:
          • Wenyu Shi, PhD
        • Sub-Investigator:
          • Yihong Cai, MD
      • Suzhou, Jiangsu, China
        • The Second Affiliated Hospital of Soochow University
        • Contact:
          • Bingzong Li, PhD
      • Taizhou, Jiangsu, China
        • Jiangsu Taizhou People's Hospital
        • Contact:
          • Jianfeng Zhu, PhD
      • Wuxi, Jiangsu, China
        • Affiliated Hospital of Jiangnan University
        • Contact:
          • Haiying Hua, PhD
      • Wuxi, Jiangsu, China
        • Wuxi People's Hospital
        • Contact:
          • Yun Zhuang, PhD
      • Wuxi, Jiangsu, China
        • Wuxi Second People's Hospital
        • Contact:
          • Zhi Wang, PhD
        • Principal Investigator:
          • Zhi Wang, PhD
        • Sub-Investigator:
          • Ping Liu, PhD
      • Yancheng, Jiangsu, China
        • Yancheng No.1 People's Hospital
        • Contact:
          • Yuexin Cheng, PhD
        • Principal Investigator:
          • Yuexin Cheng, PhD
        • Sub-Investigator:
          • Yuqing Miao, PhD
      • Yancheng, Jiangsu, China
        • Yancheng Third People's Hospital
        • Contact:
          • Naitong Sun, PhD
      • Yangzhou, Jiangsu, China
        • Subei People's Hospital
        • Contact:
          • Xiaoyan Xie, PhD
      • Yixing, Jiangsu, China
        • Yixing People'S Hospital
        • Contact:
          • Yunping Zhang, PhD
      • Zhangjiagang, Jiangsu, China
        • Zhangjiagang First People's Hospital
        • Contact:
          • Min Xu, PhD
      • Zhenjiang, Jiangsu, China
        • Affiliated Hospital of Jiangsu University
        • Contact:
          • Xiaoming Fei, PhD
      • Zhenjiang, Jiangsu, China
        • Zhenjiang First People's Hospital
        • Contact:
          • Jun Qian, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with FL and MZL who started treatment with otuzumab between June 2021 and April 2023.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1
the younger cohort (aged ≥ 18 and < 60 years at the start of treatment)
Drug: Obinutuzumab
obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.
Cohort 2
the older cohort (aged ≥ 60 years at the start of treatment)
Drug: Obinutuzumab
obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety Endpoints
Time Frame: 12 months
All AEs, SAEs, Grade 3 AEs, and all other safety variables, including vital signs, Physical examination results, and laboratory parameters.
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory Endpoints
Time Frame: 12 months
Subgroup analyses will be performed for some special populations, such as in high-risk patients
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Affiliated Hospital of Nantong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JCLG-23-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

IPD could be shared by contacting the corresponding author via email after publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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