NCT07022223

Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma

A Single-arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib Combined With Rituximab as First-line Systemic Treatment for Marginal Zone Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma.

Detailed description

Marginal zone lymphoma (MZL) is a relatively common type of B-cell non-Hodgkin lymphoma (B-NHL), with an incidence rate second only to diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). The Bruton tyrosine kinase (BTK) signaling pathway plays a significant role in B-cell malignancies. Most B-cell malignancies require activation of the B-cell receptor (BCR), and BTK, located downstream of the BCR, plays a crucial role in B-cell proliferation, apoptosis, differentiation, and migration induced by antigens. Currently, there is no unified treatment regimen with high-level evidence for the treatment of newly diagnosed MZL. As mentioned above, although high-intensity immunochemotherapy regimens achieve high response rates and durable remission, they also bring higher treatment-related safety risks (with a rate of grade 3 or higher adverse events of about 80%), including treatment-related deaths. Therefore, exploring effective chemotherapy-free regimens for MZL patients is a scientifically valuable and clinically meaningful attempt. Drugs such as BTK inhibitors and CD20 monoclonal antibodies have shown good therapeutic activity and clinical data as single agents. This is a single-arm, prospective clinical study to evaluate the efficacy and safety of orelabrutinib combined with rituximab as first-line systemic treatment for marginal zone lymphoma. All subjects will receive induction treatment with the orelabrutinib and rituximab regimen. The treatment cycle is 28 days, with a total of 6 cycles. Patients who achieve a partial response (PR) or better will enter a 2-year maintenance period with orelabrutinib.

Conditions

• Marginal Zone Lymphoma(MZL)

Interventions

Type	Name	Description
DRUG	orelabrutinib combined with rituximab regimen	All participants will receive induction therapy with the orelabrutinib and rituximab regimen. The treatment cycle is 28 days, with a total of 6 cycles. The induction treatment period is as follows: Cycle 1: Rituximab, 375 mg/m², on Day 1. Cycles 2-6:Orelabrutinib, 150 mg, once daily orally, from Day 1 to Day 28. Rituximab, 375 mg/m², on Day 1. Patients who achieve a partial response (PR) or better will enter a 2-year maintenance period with orelabrutinib.

Timeline

• Start date: 2025-03-11
• Primary completion: 2027-09-11
• Completion: 2029-09-11
• First posted: 2025-06-15
• Last updated: 2025-06-15

Locations

18 sites across 1 country: China