Obinutuzumab in Chinese Real-world Patients With iNHL

NCT ID: NCT05968001

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-20

Study Completion Date

2026-07-20

Brief Summary

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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

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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

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Lymphomas Non-Hodgkin's B-Cell

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

the younger cohort (aged ≥ 18 and \< 60 years at the start of treatment)

Obinutuzumab

Intervention Type DRUG

obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.

Cohort 2

the older cohort (aged ≥ 60 years at the start of treatment)

Obinutuzumab

Intervention Type DRUG

obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.

Interventions

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Obinutuzumab

obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

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Wenyu Shi

Director, Department of Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Changzhou No.2 People's Hospital

Changzhou, Jiangsu, China

Site Status

The First People's hospital of Changzhou

Changzhou, Jiangsu, China

Site Status

Huai'an First People's hospital

Huai'an, Jiangsu, China

Site Status

Jiangyin People's Hospital

Jiangyin, Jiangsu, China

Site Status

Jingjiang People's Hospital

Jingjiang, Jiangsu, China

Site Status

The first people's hospital of Lianyungang

Lianyungang, Jiangsu, China

Site Status

The second people's hospital of Lianyungang

Lianyungang, Jiangsu, China

Site Status

Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status

Nanjing Jiangning Hospital

Nanjing, Jiangsu, China

Site Status

Nantong Tumor Hospital

Nantong, Jiangsu, China

Site Status

Affiliated Hospital of Nantong University

Nanyang, Jiangsu, China

Site Status

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Jiangsu Taizhou People's Hospital

Taizhou, Jiangsu, China

Site Status

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Site Status

Wuxi People's Hospital

Wuxi, Jiangsu, China

Site Status

Wuxi Second People's Hospital

Wuxi, Jiangsu, China

Site Status

Yancheng No.1 People's Hospital

Yancheng, Jiangsu, China

Site Status

Yancheng Third People's Hospital

Yancheng, Jiangsu, China

Site Status

Subei People's Hospital

Yangzhou, Jiangsu, China

Site Status

Yixing People's Hospital

Yixing, Jiangsu, China

Site Status

Zhangjiagang First People's Hospital

Zhangjiagang, Jiangsu, China

Site Status

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Site Status

Zhenjiang First People's Hospital

Zhenjiang, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Wenyu Shi, PhD

Role: CONTACT

+86 13515203737

Facility Contacts

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Xuzhang Lu, PhD

Role: primary

Weiying Gu, PhD

Role: primary

Liang Yu, PhD

Role: primary

Maozhong Xu, PhD

Role: primary

Miao Sun, PhD

Role: primary

Tao Jia, PhD

Role: primary

Wanchuan Zhuang, PhD

Role: primary

Haiwen Ni, PhD

Role: primary

Jianyong Li, PhD

Role: primary

Jinning Shi, PhD

Role: primary

Xiaohong Xu, PhD

Role: primary

Wenyu Shi, PhD

Role: primary

+86 13515203737

Bingzong Li, PhD

Role: primary

Jianfeng Zhu, PhD

Role: primary

Haiying Hua, PhD

Role: primary

Yun Zhuang, PhD

Role: primary

Zhi Wang, PhD

Role: primary

Yuexin Cheng, PhD

Role: primary

Naitong Sun, PhD

Role: primary

Xiaoyan Xie, PhD

Role: primary

Yunping Zhang, PhD

Role: primary

Min Xu, PhD

Role: primary

Xiaoming Fei, PhD

Role: primary

Jun Qian, PhD

Role: primary

Other Identifiers

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JCLG-23-04

Identifier Type: -

Identifier Source: org_study_id

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