RecruitingPhase 2NCT06793189

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


Sponsor

Ruijin Hospital

Enrollment

145 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Obinutuzumab and Orelabrutinib, a drug called Obinutuzumab, Orelabrutinib and Lenalidomide, and others for people with marginal zone lymphoma (mzl). The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGObinutuzumab 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).

DRUGObinutuzumab, 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).

DRUGOrelabrutinib

Maintenance: Orelabrutinib monotherapy (150 mg once daily up to 24 months).

DRUGOrelabrutinib

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

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NCT06793189


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