Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma

Recruiting now · Not applicable

Conditions studied: Follicular Lymphoma, Treatment Naive

In brief

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.

Key facts

Study ID: NCT07126678
Run by: The First Affiliated Hospital with Nanjing Medical University
People needed: 15
Starts: 2025-07-15
Expected to finish: 2028-12-30
Last updated by the study team: 2025-08-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Voluntary participation with signed informed consent;
Age ≥18 years and ≤75 years, regardless of gender;
Life expectancy ≥3 months;
ECOG performance status 0-2; patients with ECOG 3 may be enrolled only if their decline in performance status is disease-related and the investigator judges they may benefit from treatment;
Histologically confirmed diagnosis of grade I, II, or IIIa follicular lymphoma (FL), treatment-naïve, stage III-IV disease, and meeting treatment criteria (GELF criteria);
Measurable and/or evaluable lymphoma lesions;
Adequate bone marrow reserve: absolute neutrophil count (ANC) >1.0×10⁹/L or platelets >75×10⁹/L, unless cytopenia is deemed related to bone marrow infiltration by lymphoma and the investigator believes it may recover;
Liver function: AST (SGOT), ALT (SGPT) ≤2.5×ULN (without liver involvement) or ≤5×ULN (with liver involvement); total bilirubin (TBIL) ≤ULN; serum creatinine (CRE) ≤1.5×ULN;
Creatinine clearance ≥30 mL/min (calculated by Cockcroft-Gault formula);
Ability to comply with study visit schedules and other protocol requirements;
All patients of childbearing potential must agree to use effective contraception during the study and for 24 months after treatment cessation; women of childbearing potential must have a negative urine pregnancy test before treatment initiation.

You may not qualify if…

Grade IIIb FL or transformed FL;
Received lymphoma-directed therapy within 2 weeks prior to enrollment;
Any severe medical condition, including but not limited to:
Poorly controlled hypertension (defined as failure to achieve control despite lifestyle modifications and treatment with at least 3 maximally tolerated antihypertensive drugs [including diuretics] for ≥4 weeks, or requiring ≥4 antihypertensive drugs for adequate control);
Uncontrolled congestive heart failure (NYHA class 3 [moderate] or 4 [severe]) within 6 months prior to screening;
Left ventricular ejection fraction (LVEF) <50%;
Symptomatic coronary artery disease (e.g., chest pain, palpitations, fatigue) or requiring medication;
Severe bradycardia (heart rate <40 bpm), hypotension, dizziness, or syncope; patients with arrhythmia history require cardiac evaluation;
Active bacterial, viral, fungal, or other infections (except for nail fungal infections) or major infections within 2 weeks before the first dose of study drug;
Moderate to severe liver disease (Child-Pugh B or C);
Active bleeding within 2 months before screening or clinically significant bleeding tendency per investigator judgment;
Pulmonary conditions impairing function (e.g., pulmonary fibrosis, drug-induced pneumonitis) deemed intolerable by the investigator;
Any psychiatric or cognitive impairment that may compromise understanding of informed consent, protocol compliance, or study adherence;
Known active hepatitis C virus (HCV) infection; other acquired/congenital immunodeficiency disorders, including HIV infection;
Central nervous system (CNS) involvement by lymphoma;
Diagnosis or treatment for malignancies other than lymphoma, except:
Malignancies treated with curative intent and no evidence of disease for ≥5 years before enrollment;
Adequately treated basal cell carcinoma (excluding melanoma) with no evidence of disease;
Adequately treated cervical carcinoma in situ with no evidence of disease;
Hypersensitivity to any study drug;
Pregnant or breastfeeding women;
History of stroke or intracranial hemorrhage within 6 months before enrollment;
Requiring anticoagulation with warfarin or equivalent vitamin K antagonists;
Requiring chronic use of strong CYP3A inhibitors;
Administration of live attenuated vaccines within 4 weeks before study entry.

Where it is running

Jiangsu Province Hospital — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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