Trial Title:
Obinutuzumab in Chinese Real-world Patients With iNHL
NCT ID:
NCT05968001
Condition:
Lymphomas Non-Hodgkin's B-Cell
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Obinutuzumab
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Obinutuzumab
Description:
obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.
Arm group label:
Cohort 1
Arm group label:
Cohort 2
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.
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.
Criteria for eligibility:
Study pop:
patients with FL and MZL who started treatment with otuzumab between June 2021 and April
2023.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Changzhou No.2 People's Hospital
Address:
City:
Changzhou
Country:
China
Contact:
Last name:
Xuzhang Lu, PhD
Facility:
Name:
The First People's hospital of Changzhou
Address:
City:
Changzhou
Country:
China
Contact:
Last name:
Weiying Gu, PhD
Facility:
Name:
Huai'an First People's hospital
Address:
City:
Huai'an
Country:
China
Contact:
Last name:
Liang Yu, PhD
Facility:
Name:
Jiangyin People's Hospital
Address:
City:
Jiangyin
Country:
China
Contact:
Last name:
Maozhong Xu, PhD
Investigator:
Last name:
Maozhong Xu, PhD
Email:
Principal Investigator
Investigator:
Last name:
Xi Xu, PhD
Email:
Sub-Investigator
Facility:
Name:
Jingjiang People's Hospital
Address:
City:
Jingjiang
Country:
China
Contact:
Last name:
Miao Sun, PhD
Facility:
Name:
The first people's hospital of Lianyungang
Address:
City:
Lianyungang
Country:
China
Contact:
Last name:
Tao Jia, PhD
Facility:
Name:
The second people's hospital of Lianyungang
Address:
City:
Lianyungang
Country:
China
Contact:
Last name:
Wanchuan Zhuang, PhD
Facility:
Name:
Jiangsu Province Hospital of Chinese Medicine
Address:
City:
Nanjing
Country:
China
Contact:
Last name:
Haiwen Ni, PhD
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Country:
China
Contact:
Last name:
Jianyong Li, PhD
Facility:
Name:
Nanjing Drum Tower Hospital
Address:
City:
Nanjing
Country:
China
Facility:
Name:
Nanjing Jiangning Hospital
Address:
City:
Nanjing
Country:
China
Contact:
Last name:
Jinning Shi, PhD
Facility:
Name:
Nantong Tumor Hospital
Address:
City:
Nantong
Country:
China
Contact:
Last name:
Xiaohong Xu, PhD
Facility:
Name:
Affiliated Hospital of Nantong University
Address:
City:
Nanyang
Country:
China
Contact:
Last name:
Wenyu Shi, PhD
Phone:
+86 13515203737
Email:
shiwenyu@hotmail.com
Investigator:
Last name:
Wenyu Shi, PhD
Email:
Principal Investigator
Investigator:
Last name:
Yihong Cai, MD
Email:
Sub-Investigator
Facility:
Name:
The Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Contact:
Last name:
Bingzong Li, PhD
Facility:
Name:
Jiangsu Taizhou People's Hospital
Address:
City:
Taizhou
Country:
China
Contact:
Last name:
Jianfeng Zhu, PhD
Facility:
Name:
Affiliated Hospital of Jiangnan University
Address:
City:
Wuxi
Country:
China
Contact:
Last name:
Haiying Hua, PhD
Facility:
Name:
Wuxi People's Hospital
Address:
City:
Wuxi
Country:
China
Contact:
Last name:
Yun Zhuang, PhD
Facility:
Name:
Wuxi Second People's Hospital
Address:
City:
Wuxi
Country:
China
Contact:
Last name:
Zhi Wang, PhD
Investigator:
Last name:
Zhi Wang, PhD
Email:
Principal Investigator
Investigator:
Last name:
Ping Liu, PhD
Email:
Sub-Investigator
Facility:
Name:
Yancheng No.1 People's Hospital
Address:
City:
Yancheng
Country:
China
Contact:
Last name:
Yuexin Cheng, PhD
Investigator:
Last name:
Yuexin Cheng, PhD
Email:
Principal Investigator
Investigator:
Last name:
Yuqing Miao, PhD
Email:
Sub-Investigator
Facility:
Name:
Yancheng Third People's Hospital
Address:
City:
Yancheng
Country:
China
Contact:
Last name:
Naitong Sun, PhD
Facility:
Name:
Subei People's Hospital
Address:
City:
Yangzhou
Country:
China
Contact:
Last name:
Xiaoyan Xie, PhD
Facility:
Name:
Yixing People's Hospital
Address:
City:
Yixing
Country:
China
Contact:
Last name:
Yunping Zhang, PhD
Facility:
Name:
Zhangjiagang First People's Hospital
Address:
City:
Zhangjiagang
Country:
China
Contact:
Last name:
Min Xu, PhD
Facility:
Name:
Affiliated Hospital of Jiangsu University
Address:
City:
Zhenjiang
Country:
China
Contact:
Last name:
Xiaoming Fei, PhD
Facility:
Name:
Zhenjiang First People's Hospital
Address:
City:
Zhenjiang
Country:
China
Contact:
Last name:
Jun Qian, PhD
Start date:
July 20, 2023
Completion date:
July 20, 2026
Lead sponsor:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Source:
Affiliated Hospital of Nantong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05968001
