RecruitingPhase 4NCT06134284

Clinical Study of OR for Second-line Treatment of Refractory MZL

Prospective, Multicenter, Single-arm Clinical Study of Orelabrutinib Plus Rituximab for Second-line Treatment of Relapsed/Refractory Marginal Zone Lymphoma


Sponsor

Lixia Sheng

Enrollment

39 participants

Start Date

Jan 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test the overall response rate of Orelabrutinib combined with rituximab (OR regimen) for second-line treatment of relapsed/refractory marginal zone lymphoma.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of obutinib (a BTK inhibitor) and rituximab (an anti-CD20 antibody) as a second-line treatment for marginal zone lymphoma (MZL) — a slow-growing type of B-cell blood cancer that has returned or stopped responding to prior treatment. **You may be eligible if...** - You are 18 to 80 years old with a confirmed diagnosis of marginal zone lymphoma - Your lymphoma has returned or was not controlled after at least one prior treatment - You have measurable disease on imaging - Your blood counts, heart, liver, and kidney function are adequate **You may NOT be eligible if...** - Your lymphoma has previously failed to respond to the same drug combination being tested - You have lymphoma involving the brain or spinal cord - You have significant heart problems - You have active hepatitis B, C, or HIV - You have had an organ transplant or bone marrow transplant - You have had major surgery within 6 weeks of starting the study 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

This is a single-arm trial. Patients with relapsed/refractory marginal zone lymphoma will be treated with the OR regimen. The treatment plan is as follows: Orelabrutinib 150mg oral administration once a day, Day 1-21; Rituximab 375mg/m² intravenous infusion, Day 1. Each cycle is 21 days. PET-CT evaluation will be conducted after 4 cycles. If a partial response (PR) or better is achieved, the patient will receive further treatment with the OR regimen for an additional 4 cycles before transitioning to single-agent maintenance therapy with either rituximab or obinutuzumab. If a PR or better is not achieved after 4 cycles, the patient will discontinue from the trial.


Locations(3)

The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital

Hangzhou, Zhejiang, China

86-574-87085596

Ningbo, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

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NCT06134284