Obinutuzumab in Chinese Real-world Patients With iNHL

Lymphomas Non-Hodgkin's B-Cell Clinical Trial

Official title:

Efficacy and Safety of Obinutuzumab in Chinese Patients With Indolent Non-Hodgkin's B-cell Lymphoma in the Real-World.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05968001
• Other study ID #: JCLG-23-04
• Status: Not yet recruiting
• Start date: July 20, 2023
• Est. completion date: July 20, 2026

Study information

• Verified date: July 2023
• Source: Affiliated Hospital of Nantong University
• Contact: Wenyu Shi, PhD
• Phone: +86 13515203737
• Email: shiwenyu[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: July 20, 2026
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphomas Non-Hodgkin's B-Cell

Intervention

Drug:
• Obinutuzumab
obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.

Locations

Country	Name	City	State
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	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Jiangsu Province Hospital of Chinese Medicine	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Affiliated Hospital of Nantong University	Nanyang	Jiangsu
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Jiangsu Taizhou People's Hospital	Taizhou	Jiangsu
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Wuxi Second People's Hospital	Wuxi	Jiangsu
China	Yancheng No.1 People's Hospital	Yancheng	Jiangsu
China	Yancheng Third People's Hospital	Yancheng	Jiangsu
China	Subei People's Hospital	Yangzhou	Jiangsu
China	Yixing People's Hospital	Yixing	Jiangsu
China	Zhangjiagang First People's Hospital	Zhangjiagang	Jiangsu
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
China	Zhenjiang First People's Hospital	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Endpoints	Subgroup analyses will be performed for some special populations, such as in high-risk patients	12 months
Primary	Efficacy Endpoints	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	Safety Endpoints	All AEs, SAEs, Grade 3 AEs, and all other safety variables, including vital signs, Physical examination results, and laboratory parameters.	12 months