NCT05899621

A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL

A Real-world Study of the Efficacy and Safety of Obinutuzumab-based Therapy for Previously Untreated Follicular Lymphoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 332 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma

Detailed description

This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Obinutuzumab	Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Lenalidomide	Lenalidomide PO will be administered as per the schedule specified in the respective arm.
DRUG	Bendamustine	Bendamustine IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Cyclophosphamide	Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Doxorubicin	Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Vincristine	Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Prednisone	Prednisone PO will be administered as per the schedule specified in the respective arm.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-06-30
• Completion: 2027-06-30
• First posted: 2023-06-12
• Last updated: 2023-06-12

Locations

1 site across 1 country: China