RecruitingPhase 2NCT07022223

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

51 participants

Start Date

Mar 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two blood cancer drugs — orelabrutinib and rituximab — as the first systemic treatment for people with a type of slow-growing lymphoma called marginal zone lymphoma (MZL), including MALT, splenic, and nodal subtypes. **You may be eligible if...** - You are 18 or older - You have histologically confirmed CD20-positive marginal zone lymphoma with a lesion larger than 1.5 cm outside the spleen - Your MZL has progressed or come back after local treatments (such as radiation, surgery, or antibiotic therapy for H. pylori), or local treatment is not appropriate - You have a medical reason to start systemic treatment (e.g., symptoms, low blood counts, or risk of organ damage) - Your performance status is ECOG 0–2 **You may NOT be eligible if...** - You have previously received systemic chemotherapy or immunotherapy for this lymphoma - You have active, uncontrolled infections or severe liver/kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

DRUGorelabrutinib 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.


Locations(18)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Dongyang People's Hospital

Dongyang, China

Affiliated Hangzhou First People's Hospital

Hangzhou, China

Zhejiang cancer Hospital

Hangzhou, China

Huzhou Central Hospital

Huzhou, China

Affiliated Hospital of Jiaxing University

Jiaxing, China

The Second Affiliated Hospital of Jiaxing University

Jiaxing, China

Lishui central Hospital

Lishui, China

the Affiliated Peopele'S Hospital of Ningbo University

Ningbo, China

Quzhou People's Hospital

Quzhou, China

Shaoxing Central Hospital

Shaoxing, China

shaoxing People's Hospital

Shaoxing, China

Taizhou Central Hospital

Taizhou, China

Taizhou First People's Hospital

Taizhou, China

Taizhou Hospital ofzhejiang Province

Taizhou, China

The Second Affiliated Hospital and Yuying childrens Hospital of Wenzhou Medical University

Wenzhou, China

Yuyao People's Hospital

Yuyao, China

Affiliated Zhuji Hospital ofWenzhou Medical University

Zhuji, China

View Full Details on ClinicalTrials.gov

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NCT07022223


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