Obinutuzumab in Chinese Real-world Patients With iNHL
Efficacy and Safety of Obinutuzumab in Chinese Patients With Indolent Non-Hodgkin's B-cell Lymphoma in the Real-World.
1 other identifier
observational
400
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2023
CompletedFirst Submitted
Initial submission to the registry
July 23, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2026
ExpectedAugust 1, 2023
July 1, 2023
1.4 years
July 23, 2023
July 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Safety Endpoints
12 months
Other Outcomes (1)
Exploratory Endpoints
12 months
Study Arms (2)
Cohort 1
the younger cohort (aged ≥ 18 and \< 60 years at the start of treatment)
Cohort 2
the older cohort (aged ≥ 60 years at the start of treatment)
Interventions
obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.
Eligibility Criteria
patients with FL and MZL who started treatment with otuzumab between June 2021 and April 2023.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
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 of Chinese Medicine
Nanjing, Jiangsu, China
Jiangsu Province Hospital
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, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Oncology
Study Record Dates
First Submitted
July 23, 2023
First Posted
August 1, 2023
Study Start
July 20, 2023
Primary Completion
December 30, 2024
Study Completion (Estimated)
July 20, 2026
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- starting 6 months after publication
- Access Criteria
- IPD could be shared by contacting the corresponding author via email after publication.
all IPD that underlie results in a publication