NCT05968001

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
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphomas Non-Hodgkin's B-Cell

Interventions

Type	Name	Description
DRUG	Obinutuzumab	obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.

Timeline

• Start date: 2023-07-20
• Primary completion: 2024-12-30
• Completion: 2026-07-20
• First posted: 2023-08-01
• Last updated: 2023-08-01

Locations

25 sites across 1 country: China

Regulatory

• FDA-regulated drug study