NCT06700798

Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial

A Randomized, Open-Label Phase II Clinical Study of Orelabrutinib Combined With Rituximab Versus R-CVP in the Treatment of Newly Diagnosed Marginal Zone Lymphoma (MZL).

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Fei Li · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, open-label, multicenter, prospective clinical trial aimed at evaluating the efficacy and safety of orelabrutinib combined with rituximab for the previously untreat MZL

Detailed description

For patients with advanced-stage MZL who require treatment, immunochemotherapy is the standard therapy, including regimens such as BR, R-CHOP, R-CVP, etc. The second-generation BTK inhibitor, orelabrutinib, has shown promising efficacy in relapsed/refractory MZL, suggesting that a chemofree regimen combining orelabrutinib with rituximab could also achieve good clinical outcomes in first-line treatment of MZL. However, there is still a lack of prospective studies to confirm this. This study plans to compare the efficacy and safety of orelabrutinib combined with rituximab followed by maintenance therapy with orelabrutinib to the R-CVP regimen.

Conditions

• Marginal Zone Lymphoma(MZL)

Interventions

Type	Name	Description
DRUG	Orelabrutinib	150mg po
DRUG	rituximab	375mg/m\^2, intravenous
DRUG	Cyclophosphamide	750mg/m\^2
DRUG	Vincristine	1.4mg/m\^2
DRUG	Prednisone tablet	60mg/m\^2

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-05-04
• Completion: 2027-12-04
• First posted: 2024-11-22
• Last updated: 2025-06-17

Locations

1 site across 1 country: China