RecruitingPhase 2NCT07165769

Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Newly Diagnosed Splenic B-cell Lymphoma With Prominent Nucleoli (SBLPN): A Prospective, Open-label, Single-arm Clinical Trial


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

47 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

:The aim of this study was to analyze the safety and efficacy of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Newly Diagnosed Splenic B-cell Lymphoma with Prominent Nucleoli (SBLPN). The main questions it aims to explore the Preliminary Efficacy of the Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) Regimen in the Treatment of Newly Diagnosed SBLPN Patients. To explore the safety of zanubrutinib, obinutuzumab combined with lenalidomide (ZGR) in the treatment of newly diagnosed SBLPN patients.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a three-drug combination — zanubrutinib, obinutuzumab, and lenalidomide — in people newly diagnosed with a rare type of spleen lymphoma called splenic B-cell lymphoma with prominent nucleoli (SBLPN). All three drugs target cancer cells in different ways, and researchers want to see how effective and safe this combination is. **You may be eligible if...** - You are between 18 and 80 years old - You have been confirmed by biopsy to have SBLPN that needs treatment - You have never received any systemic (body-wide) treatment for this lymphoma before - You are generally well enough to be active most of the day - Your blood counts and organ function (liver, kidneys) meet minimum levels - You agree to use contraception during and for 4 weeks after treatment **You may NOT be eligible if...** - You have been diagnosed with lymphoma in the brain or spinal cord within the past year - You have had another cancer in the last 3 years (some skin cancers excepted) - You are pregnant or breastfeeding - You have severe heart problems, uncontrolled high blood pressure, or blood clotting disorders - You are on long-term immune-suppressing medications 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

DRUGInduction Therapy

All enrolled patients will receive the ZGR regimen (zanubrutinib, obinutuzumab, and lenalidomide) for induction therapy. Each cycle lasts 28 days, up to 6 cycles, followed by maintenance therapy. Patients experiencing disease progression during induction will discontinue the trial drugs but remain under survival follow-up. 1. Zanubrutinib: 160 mg twice daily, administered orally continuously. 2. Obinutuzumab: 1000 mg via intravenous infusion, administered on Days 1, 8, and 15 of Cycle 1 and subsequently on Day 1 of Cycles 2-6. 3. Lenalidomide: 25 mg once daily, taken orally on Days 1-21 of each 28-day cycle until disease progression. Doses should be taken at approximately the same time daily.

DRUGMaintenance Therapy

Maintenance therapy consists of zanubrutinib plus lenalidomide: Lenalidomide is continued for 1 year. Zanubrutinib is continued for 2 years. Treatment continues until disease progression, intolerability, or completion of 2 years. For patients who do not achieve complete remission (CR), therapy may continue until progression or intolerability. 1. Zanubrutinib: 160 mg twice daily, administered orally continuously. 2. Lenalidomide: 10 mg once daily, taken orally on Days 1-21, followed by a 7-day rest period, constituting a 28-day cycle.


Locations(1)

Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT07165769