NCT06793189

MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL

A Prospective Study to Evaluate the Efficacy and Safety of MZL-IPI Risk-adapted Targeted Therapy in Patients With Untreated Marginal Zone B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Marginal zone lymphoma (MZL) is a common type of indolent lymphoma that originates from the marginal zone of lymphoid follicles. This study aims to evaluate targeted therapy based on the prognostic risk stratification of MZL-IPI in newly diagnosed MZL cases requiring systemic treatment, and provides a basis for precision treatment of MZL.

Conditions

• Marginal Zone Lymphoma(MZL)

Interventions

Type	Name	Description
DRUG	Obinutuzumab and Orelabrutinib	Induction: Obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1; 1000 mg on day 1 of cycles 2-6, cycle length=21 days) and Orelabrutinib (150 mg once daily).
DRUG	Obinutuzumab, Orelabrutinib and Lenalidomide	Induction: Obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1; 1000 mg on day 1 of cycles 2-6, cycle length=21 days), Orelabrutinib (150 mg once daily), and Lenalidomide (25 mg on days 2-11 of cycles 1-6, cycle length=21 days).
DRUG	Orelabrutinib	Maintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months).
DRUG	Orelabrutinib	Maintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months).

Timeline

• Start date: 2025-01-23
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-01-27
• Last updated: 2026-03-24

Locations

3 sites across 1 country: China