NCT07492407

CD20 Monoclonal Antibody-Based First-Line Therapy in Treatment-Naive Marginal Zone B-Cell Lymphoma

Risk-Stratified Real-World Multicenter Study of the Efficacy and Safety of CD20 Monoclonal Antibody-Based First-Line Therapy in Treatment-Naive Marginal Zone B-Cell Lymphoma

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 131 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, real-world study on first-line CD20 monoclonal antibody-based regimens for treatment-naive marginal zone B-cell lymphoma based on risk stratification. The primary objective is to evaluate the efficacy and safety of the "BR", "R2", and "OR2" treatment regimens in treatment-naive MZL patients receiving first-line CD20 monoclonal antibody-based therapy stratified by risk.

Conditions

• MZL

Interventions

Type	Name	Description
DRUG	R2/BR/OR2	R2 regimen: 28-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Lenalidomide was given orally at 20 mg per day from Day 1 to Day 21 of each cycle (Cycles 1-6). BR regimen: 28-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Bendamustine was given via intravenous infusion at 70 mg/m² on Day 1 and Day 2 of each cycle (Cycles 1-6). OR2 regimen: 21-day cycle Rituximab was administered at a dose of 375 mg/m² via intravenous infusion on Day 1 of each cycle (Cycles 1-6); Lenalidomide was given orally at 20 mg per day from Day 2 to Day 11 of each cycle (Cycles 1-6); Orelabrutinib was administered orally at 150 mg per day for 2 years .

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2026-03-25
• Last updated: 2026-03-25