NCT07372365

Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.

Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve Marginal Zone Lymphoma: A Study of Efficacy and Safety.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore a new treatment approach for patients with treatment-naive Marginal Zone Lymphoma (MZL). MZL is a type of slow-growing lymphoma that often affects older adults. The current standard treatment involves chemotherapy, but it can have significant side effects and may not always provide long-term benefits. This study investigates a treatment strategy that combines a limited course of chemotherapy (R-CHOP) followed by consolidation and maintenance therapy with a targeted drug called Orelabrutinib. Patients will undergo a series of tests to determine eligibility for the study. These tests include blood work, imaging studies, and assessments of overall health. Eligible participants will receive a standard chemotherapy regimen called R-CHOP for three cycles. After this, the response to treatment will be evaluated. Participants who show a good response will then receive three cycles of consolidation therapy with Orelabrutinib and Rituximab (OR). Those who continue to respond well will enter a maintenance phase with Orelabrutinib for up to two years. Throughout the study, participants will be closely monitored for treatment response and any side effects. Regular check-ups, blood tests, and imaging studies will be conducted to assess the effectiveness and safety of the treatment. This study is an important step towards finding better treatment options for MZL patients. It is hoped that through this research, the quality of life and outcomes for those affected by this disease can be improved.

Conditions

• Marginal Zone Lymphoma (MZL)

Interventions

Type	Name	Description
DRUG	Orelabrutinib Consolidation and Maintenance Therapy	Eligible subjects will receive R-CHOP regimen (with a 21-day cycle). After 3 cycles of treatment, the efficacy will be assessed. Subjects with disease progression or those who do not achieve partial remission (PR) after treatment will discontinue treatment. The remaining subjects will continue to receive 3 cycles of OR regimen for consolidation therapy. After 6 cycles, efficacy will be assessed again. Subjects assessed as complete remission (CR) or PR will enter the orelabrutinib maintenance treatment phase for a total of 2 years, until completion of the protocol treatment, disease progression, or unacceptable toxicity (whichever occurs first).

Timeline

• Start date: 2025-10-24
• Primary completion: 2028-04-01
• Completion: 2030-10-01
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: China