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.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05968001

Enrollment

400

Registered

2023-08-01

Start date

2023-07-20

Completion date

2026-07-20

Last updated

2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphomas Non-Hodgkin's B-Cell

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.

Interventions

DRUGObinutuzumab

obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Safety Endpoints	12 months	All AEs, SAEs, Grade 3 AEs, and all other safety variables, including vital signs, Physical examination results, and laboratory parameters.

Other

Measure	Time frame	Description
Exploratory Endpoints	12 months	Subgroup analyses will be performed for some special populations, such as in high-risk patients

Countries

China

Contacts

Primary ContactWenyu Shi, PhD

shiwenyu@hotmail.com+86 13515203737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026