RecruitingNot ApplicableNCT07126678

Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma

Prospective Exploratory Study of Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

15 participants

Start Date

Jul 15, 2025

Study Type

INTERVENTIONAL

Conditions

Follicular Lymphoma Treatment Naive

Summary

This study investigates a fixed-duration regimen of zanubrutinib, bendamustine, and obinutuzumab (ZBG) in the treatment of treatment-naïve patients with advanced-stage follicular lymphoma. Patients will receive combination therapy with zanubrutinib, bendamustine, and obinutuzumab over 6 cycles, with each cycle lasting 28 days. The specific dosing schedule is as follows: Bendamustine 70 mg/m²: administered intravenously on Days 2-3 of Cycle 1, and on Days 1-2 of Cycles 2-6. Obinutuzumab 1000 mg: administered intravenously on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 (every 28-day cycle). Zanubrutinib 160 mg orally twice daily (bid), continuously throughout Cycles 1-6. Treatment is discontinued after 6 cycles, with no subsequent maintenance therapy. Primary endpoint is 2-year PFS. Secondary endpoints include: CR rate after 6 cycles, ORR after 3 and 6 cycles MRD-negative rate after 3 and 6 cycles, OS, safety and tolerability.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three cancer medications — zanubrutinib, bendamustine, and obinutuzumab — in people with advanced follicular lymphoma (a slow-growing type of blood cancer) who have never been treated before. **You may be eligible if...** - You are between 18 and 75 years old - You have been newly diagnosed with stage III or IV follicular lymphoma (grade I, II, or IIIa) - You have not received any prior lymphoma treatment - Your cancer meets treatment criteria (called GELF criteria) - Your heart, liver, and kidney function are within acceptable ranges - You are willing to use contraception during the study and for 2 years after **You may NOT be eligible if...** - Your lymphoma has transformed or is grade IIIb - You have uncontrolled heart failure, severe heart conditions, or very high blood pressure despite treatment - You have HIV, active hepatitis C, or active serious infections - You have cancer spread to the brain - You have another active cancer (with some exceptions) - You are pregnant or breastfeeding - You have had a stroke in the past 6 months - You are on blood thinners like warfarin 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

DRUGzanubrutinib, bendamustine, and obinutuzumab

Patients will receive combination therapy with zanubrutinib, bendamustine, and obinutuzumab over 6 cycles, with each cycle lasting 28 days. The specific dosing schedule is as follows: Bendamustine 70 mg/m²: administered intravenously on Days 2-3 of Cycle 1, and on Days 1-2 of Cycles 2-6. Obinutuzumab 1000 mg: administered intravenously on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 (every 28-day cycle). Zanubrutinib 160 mg orally twice daily (bid), continuously throughout Cycles 1-6. Treatment is discontinued after 6 cycles, with no subsequent maintenance therapy.