NCT07003464

Phase II Trial of Zanubrutinib, Obinutuzumab, Bendamustine (ZGB) as First-Line Therapy for Chronic Lymphocytic Leukemia: A Single-Center Study

Efficacy and Safety of Zanubrutinib, Obinutuzumab, and Bendamustine (ZGB) Regimen for First-Line Treatment of Chronic Lymphocytic Leukemia: A Single-Arm, Prospective Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open label, national multicenter clinical study included patients with chronic lymphocytic leukemia (CLL). The treatment combines three medications: Zanubrutinib , Obinutuzumab and Bendamustine . Together, these drugs aim to achieve deep remission (no detectable cancer cells) and allow a shorter treatment duration compared to lifelong therapies.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Zanubrutinib	160 mg (2 tablets) BID. Each 4-week period constitutes one treatment cycle.
DRUG	Obinutuzumab	1000 mg IV (Days 1, 8, 15 of Cycle 1; Day 1 thereafter).Each 4-week period constitutes one treatment cycle.
DRUG	Bendamustine	70 mg/m² (Days 1-2 per cycle) for induction only (Cycles 1-4).Each 4-week period constitutes one treatment cycle.

Timeline

• Start date: 2025-06-15
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: China