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Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma
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.
Details
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 15 |
| Start date | Tue Jul 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sat Dec 30 2028 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Follicular Lymphoma
- Treatment Naive
Interventions
- zanubrutinib, bendamustine, and obinutuzumab
Countries
China