RecruitingPhase 2NCT07372365

Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve MZL.

Orelabrutinib as Consolidation and Maintenance Therapy in Treatment-Naïve Marginal Zone Lymphoma: A Study of Efficacy and Safety.


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

23 participants

Start Date

Oct 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to explore a new treatment approach for patients with treatment-naive Marginal Zone Lymphoma (MZL). MZL is a type of slow-growing lymphoma that often affects older adults. The current standard treatment involves chemotherapy, but it can have significant side effects and may not always provide long-term benefits. This study investigates a treatment strategy that combines a limited course of chemotherapy (R-CHOP) followed by consolidation and maintenance therapy with a targeted drug called Orelabrutinib. Patients will undergo a series of tests to determine eligibility for the study. These tests include blood work, imaging studies, and assessments of overall health. Eligible participants will receive a standard chemotherapy regimen called R-CHOP for three cycles. After this, the response to treatment will be evaluated. Participants who show a good response will then receive three cycles of consolidation therapy with Orelabrutinib and Rituximab (OR). Those who continue to respond well will enter a maintenance phase with Orelabrutinib for up to two years. Throughout the study, participants will be closely monitored for treatment response and any side effects. Regular check-ups, blood tests, and imaging studies will be conducted to assess the effectiveness and safety of the treatment. This study is an important step towards finding better treatment options for MZL patients. It is hoped that through this research, the quality of life and outcomes for those affected by this disease can be improved.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether orelabrutinib (a targeted oral therapy called a BTK inhibitor) can help maintain remission in people with marginal zone lymphoma (MZL) — a slow-growing type of blood cancer — after they complete standard immunotherapy with rituximab. **You may be eligible if...** - You are 18 or older - You have been diagnosed with marginal zone lymphoma confirmed by biopsy, and have not received any prior systemic treatment - Your lymphoma has relapsed after or cannot be treated with local treatments (such as surgery, radiation, or H. pylori eradication) - You are in acceptable physical condition (ECOG 0–2) - Your blood counts, heart, kidney, and liver function meet required levels - Your life expectancy is more than 3 months **You may NOT be eligible if...** - You have had major surgery or injury within 2 weeks of enrollment - You are pregnant or breastfeeding without effective contraception - You have active serious infections or HIV, active hepatitis B or C 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 Consolidation and Maintenance Therapy

Eligible subjects will receive R-CHOP regimen (with a 21-day cycle). After 3 cycles of treatment, the efficacy will be assessed. Subjects with disease progression or those who do not achieve partial remission (PR) after treatment will discontinue treatment. The remaining subjects will continue to receive 3 cycles of OR regimen for consolidation therapy. After 6 cycles, efficacy will be assessed again. Subjects assessed as complete remission (CR) or PR will enter the orelabrutinib maintenance treatment phase for a total of 2 years, until completion of the protocol treatment, disease progression, or unacceptable toxicity (whichever occurs first).


Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT07372365


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