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

NCT06415708 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-05-16

No results posted yet for this study

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.

Conditions

  • B Cell Lymphoma

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.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Shuhua Yi, Dr · Institute of Hematology & Blood Diseases Hospital, Chinese

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2024-11-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06415708 on ClinicalTrials.gov