Obinutuzumab in Chinese Real-world Patients With iNHL
- Registration Number
- NCT05968001
- Lead Sponsor
- Affiliated Hospital of Nantong University
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 2 Obinutuzumab the older cohort (aged ≥ 60 years at the start of treatment) Cohort 1 Obinutuzumab the younger cohort (aged ≥ 18 and \< 60 years at the start of treatment)
- Primary Outcome Measures
Name Time Method Efficacy Endpoints 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.
- Secondary Outcome Measures
Name Time Method Safety Endpoints 12 months All AEs, SAEs, Grade 3 AEs, and all other safety variables, including vital signs, Physical examination results, and laboratory parameters.
Trial Locations
- Locations (25)
Wuxi Second People's Hospital
🇨🇳Wuxi, Jiangsu, China
Changzhou No.2 People's Hospital
🇨🇳Changzhou, Jiangsu, China
The First People's hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Huai'an First People's hospital
🇨🇳Huai'an, Jiangsu, China
Jiangyin People's Hospital
🇨🇳Jiangyin, Jiangsu, China
Jingjiang People's Hospital
🇨🇳Jingjiang, Jiangsu, China
The first people's hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
The second people's hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Nanjing Jiangning Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
Jiangsu Province Hospital of Chinese Medicine
🇨🇳Nanjing, Jiangsu, China
Jiangsu Taizhou People's Hospital
🇨🇳Taizhou, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University
🇨🇳Wuxi, Jiangsu, China
Affiliated Hospital of Nantong University
🇨🇳Nanyang, Jiangsu, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Yancheng Third People's Hospital
🇨🇳Yancheng, Jiangsu, China
Zhangjiagang First People's Hospital
🇨🇳Zhangjiagang, Jiangsu, China
Yancheng No.1 People's Hospital
🇨🇳Yancheng, Jiangsu, China
Yixing People's Hospital
🇨🇳Yixing, Jiangsu, China
Subei People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Zhenjiang First People's Hospital
🇨🇳Zhenjiang, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China