NCT07126678招募中不适用
Prospective Exploratory Study of Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年7月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 2-year PFS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ZBG
Experimental
干预措施: zanubrutinib, bendamustine, and obinutuzumab (Drug)
结局指标
主要结局
2-year PFS
时间窗: 2 year
2-year progression-free survival (PFS)
次要结局
- CR Rate(At the end of Cycle 6 (each cycle is 28 days))
- ORR(At the end of Cycle 3 and 6 (each cycle is 28 days))
- MRD(At the end of Cycle 6 (each cycle is 28 days))
- OS(From date of randomization until the date of death from any cause, assessed up to 100 months)
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE(2 year)
研究者
研究点 (1)
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