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

Not yet recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

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

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

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)

July 20, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

July 20, 2026

Study Registration Dates

First Submitted

July 23, 2023

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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