NCT06415708

Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma

Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma: an Open-label, Multicenter Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center, single-arm clinical study to evaluate the efficacy and safety of maintenance therapy with obinutuzumab for 2 years in patients ≥ 18 years of age with newly diagnosed mature B-cell lymphoma (including follicular lymphoma\[FL\], marginal zone cell lymphoma\[MZL\] , waldenström macroglobulinemia\[WM\], hairy-cell leukemia variant\[HCL-v\]) who achieved ≥ PR after 6 cycles of obinutuzumab in combination with bendamustine.

Detailed description

This study will explore whether induction therapy with obinutuzumab in combination with bendamustine followed by maintenance therapy with obinutuzumab in treatment-naïve patients with mature B-cell lymphoma will improve the prognosis of patients with this type of indolent mature B-cell lymphoma and the efficacy and safety of this regimen in different lymphoma subtypes.

Conditions

• B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Obinutuzumab Combined With Bendamustine	The treatment is divided into two phases: induction therapy and maintenance therapy Induction therapy: 6 cycles of obinutuzumab (1000 mg, IV) on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-6 (28 days/cycle). Bendamustine (90 mg/m2, IV) on Days 1 and 2 of Cycles 1-6. Maintenance therapy: Patients who achieved at least a partial response after 6 months of induction therapy were eligible to enter the maintenance phase, during which obinutuzumab (1000 mg, IV) was administered every 2 months for 2 years.

Timeline

• Start date: 2023-11-30
• Primary completion: 2024-11-30
• Completion: 2026-06-30
• First posted: 2024-05-16
• Last updated: 2024-05-16

Locations

1 site across 1 country: China