Actively Recruiting
Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-08-17
15
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study investigates a fixed-duration regimen of zanubrutinib, bendamustine, and obinutuzumab (ZBG) in the treatment of treatment-naïve patients with advanced-stage follicular lymphoma. Patients will receive combination therapy with zanubrutinib, bendamustine, and obinutuzumab over 6 cycles, with each cycle lasting 28 days. The specific dosing schedule is as follows: Bendamustine 70 mg/m²: administered intravenously on Days 2-3 of Cycle 1, and on Days 1-2 of Cycles 2-6. Obinutuzumab 1000 mg: administered intravenously on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 (every 28-day cycle). Zanubrutinib 160 mg orally twice daily (bid), continuously throughout Cycles 1-6. Treatment is discontinued after 6 cycles, with no subsequent maintenance therapy. Primary endpoint is 2-year PFS. Secondary endpoints include: CR rate after 6 cycles, ORR after 3 and 6 cycles MRD-negative rate after 3 and 6 cycles, OS, safety and tolerability.
CONDITIONS
Official Title
Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Age 18 to 75 years, any gender
- Life expectancy of at least 3 months
- ECOG performance status 0-2; ECOG 3 allowed if disease-related decline and investigator agrees
- Histologically confirmed grade I, II, or IIIa follicular lymphoma, treatment-naive, stage III-IV, meeting GELF criteria
- Measurable or evaluable lymphoma lesions
- Adequate bone marrow reserve: ANC >1.0 x10^9/L or platelets >75 x10^9/L unless related to lymphoma infiltration
- Liver function: AST and ALT ≤2.5x ULN (without liver involvement) or ≤5x ULN (with liver involvement); total bilirubin ≤ULN; creatinine ≤1.5x ULN
- Creatinine clearance ≥30 mL/min (Cockcroft-Gault formula)
- Ability to comply with study visits and protocol
- Patients of childbearing potential must use effective contraception during and for 24 months after treatment; women must have negative pregnancy test before treatment
You will not qualify if you...
- Grade IIIb or transformed follicular lymphoma
- Received lymphoma-directed therapy within 2 weeks before enrollment
- Severe medical conditions including:
- Poorly controlled hypertension despite treatment
- Uncontrolled congestive heart failure (NYHA class 3 or 4) within 6 months
- Left ventricular ejection fraction below 50%
- Symptomatic coronary artery disease or requiring medication
- Severe bradycardia (heart rate <40 bpm), hypotension, dizziness, or syncope
- Active infections (except nail fungal infections) or major infections within 2 weeks before first dose
- Moderate to severe liver disease (Child-Pugh B or C)
- Active bleeding within 2 months or clinically significant bleeding tendency
- Pulmonary conditions impairing function deemed intolerable
- Psychiatric or cognitive impairment affecting consent or adherence
- Known active hepatitis C or immunodeficiency including HIV
- Central nervous system involvement by lymphoma
- Other malignancies except treated basal cell carcinoma, cervical carcinoma in situ, or malignancies in remission ≥5 years
- Hypersensitivity to study drugs
- Pregnant or breastfeeding women
- History of stroke or intracranial hemorrhage within 6 months
- Requirement for anticoagulation with warfarin or equivalent
- Chronic use of strong CYP3A inhibitors
- Live attenuated vaccines within 4 weeks before study entry
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
Y
Yi Xia
CONTACT
J
Jianyong Li Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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