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RECRUITING
NCT06415708
PHASE2

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2023-11-30

Completion Date

2026-06-30

Last Updated

2024-05-16

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

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

Tianjin, Tianjin Municipality, China