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RECRUITING
NCT06793189
PHASE2

MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

145

Start Date

2025-01-23

Completion Date

2028-12-31

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

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).

Locations (3)

Shanghai Ruijin Hospital

Shanghai, China, China

Affiliated First Hospital of China Medical University

Shenyang, Liaoning, China

Peking University Third Hospital

Beijing, China