Phase 2 Trial: Obinutuzumab with CHOP vs Bendamustine for Follicular Lymphoma Grade 3A

This multicenter Phase 2 randomized clinical trial compares the efficacy and safety of two treatment regimens for newly diagnosed Follicular Lymphoma Grade 3A (FL). The study will evaluate Obinutuzumab combined with CHOP chemotherapy versus Obinutuzumab combined with Bendamustine in 133 adult patients.

Key study features include:

• Randomized, open-label, parallel-group design
• Primary endpoint: Progression-Free Survival (PFS) assessed over 5 years
• Secondary endpoints include Complete Response rates, Overall Survival, and early progression assessment (POD24)
• Conducted at multiple centers with estimated completion in November 2030

Treatment arms:

1. Active Comparator Arm: Obinutuzumab (1000mg IV) with CHOP regimen (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) administered in 21-day cycles for up to 6 cycles, followed by 2 cycles of Obinutuzumab monotherapy
2. Experimental Arm: Obinutuzumab (1000mg IV) with Bendamustine (90mg/m²) administered in 28-day cycles for up to 6 cycles

Eligibility criteria require patients to have histologically confirmed CD20+ FL Grade 3A with measurable lesions and no prior systemic lymphoma treatment. Key exclusions include CNS involvement, active infections, HIV/AIDS, uncontrolled hepatitis, significant comorbidities, and pregnancy.

The study aims to determine which combination therapy shows superior outcomes in this specific FL subtype, potentially influencing future treatment guidelines for this rare but clinically important lymphoma variant.