Clinical trial NCT05968001: Obinutuzumab in Chinese Real-world Patients With iNHL
Official title: Efficacy and Safety of Obinutuzumab in Chinese Patients With Indolent Non-Hodgkin's B-cell Lymphoma in the Real-World.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lymphomas Non-Hodgkin's B-Cell
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with FL and MZL who started treatment with otuzumab between June 2021 and April 2023.

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.

Eligibility 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.

Primary outcomes:
measure: Efficacy Endpoints
timeFrame: 12 months
Secondary outcomes:
measure: Safety Endpoints
timeFrame: 12 months
Other outcomes:
measure: Exploratory Endpoints
timeFrame: 12 months
Locations:
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Changzhou
country: China
facility: The First People's hospital of Changzhou
state: Jiangsu
city: Huai'an
country: China
facility: Huai'an First People's hospital
state: Jiangsu
city: Jiangyin
country: China
facility: Jiangyin People's Hospital
state: Jiangsu
city: Jingjiang
country: China
facility: Jingjiang People's Hospital
state: Jiangsu
city: Lianyungang
country: China
facility: The first people's hospital of Lianyungang
state: Jiangsu
city: Lianyungang
country: China
facility: The second people's hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Jiangning Hospital
state: Jiangsu
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Nanyang
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Taizhou
country: China
facility: Jiangsu Taizhou People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Second People's Hospital
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng No.1 People's Hospital
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng Third People's Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Subei People's Hospital
state: Jiangsu
city: Yixing
country: China
facility: Yixing People's Hospital
state: Jiangsu
city: Zhangjiagang
country: China
facility: Zhangjiagang First People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Zhenjiang
country: China
facility: Zhenjiang First People's Hospital
state: Jiangsu
Study officials:
References: