RecruitingPhase 2NCT07441993

Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL

Orelabrutinib for the Treatment of Marginal Zone Lymphoma: A Phase II, Multicenter, Open-label Study


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

30 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, multicenter, prospective, phase II study. The primary objective is to assess the efficacy and safety of orelabrutinib in treatment-naïve patients with marginal zone lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing orelabrutinib — a targeted oral therapy that blocks a cancer-driving protein — as a treatment for early-stage (stage I or II) marginal zone lymphoma (MZL), a slow-growing type of non-Hodgkin lymphoma that has not been treated before. **You may be eligible if...** - You are 18 or older - You have been confirmed to have stage I or II marginal zone lymphoma by biopsy - You have not yet received treatment for this lymphoma - Your general health is good enough to carry out daily activities (ECOG 0–2) - Your blood counts, liver, and kidney function are within acceptable ranges - Your expected survival is at least 12 months **You may NOT be eligible if...** - Your lymphoma has spread to the brain or transformed into a more aggressive type - You have significant heart problems (heart failure, recent heart attack, or dangerous heart rhythms) - You have had active bleeding in the last 2 months or are currently on blood thinners - You have poorly controlled high blood pressure despite multiple medications - You have a history of clinically meaningful irregular heart rhythms (prolonged QT interval) 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

Induction phase (cycle 1-6): Orelabrutinib (150 mg)


Locations(14)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Province People's Hospital

Nanjing, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Cancer Hospital & Institute

Jinan, Shandong, China

Shandong Provincial Hospital

Jinan, Shandong, China

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Hematology Hospital, Chinese Academy of Medical Sciences

Tianjin, China

View Full Details on ClinicalTrials.gov

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NCT07441993


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