[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602681":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":30,"responsibleParty":48,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ZBG","EXPERIMENTAL",null,[13],"Drug: zanubrutinib, bendamustine, and obinutuzumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","zanubrutinib, bendamustine, and obinutuzumab","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\u002Fm²: 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.\n\nTreatment is discontinued after 6 cycles, with no subsequent maintenance therapy.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Yi Xia","CONTACT","+86 25 68307573","cynthia0311@163.com",{"name":27,"role":23,"phone":11,"phoneExt":28,"email":29},"Jianyong Li Li","+86 25 6830757","lijianyonglm@126.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Jiangsu Province Hospital","RECRUITING","Nanjing","Jiangsu","210000","China","CN",{"type":40,"coordinates":41},"Point",[42,43],118.77778,32.06167,{"lat":43,"lon":42},[46],{"name":22,"role":23,"phone":47,"phoneExt":11,"email":25},"13770698391",{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100602681","fixed-duration-zanubrutinib-bendamustine-and-obinutuzumab-zbg-in-treatment-nave-advanced-stage-follicular-lymphoma-100602681",false,"NCT07126678","Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma","Prospective Exploratory Study of Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent;\n2. Age ≥18 years and ≤75 years, regardless of gender;\n3. Life expectancy ≥3 months;\n4. 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;\n5. Histologically confirmed diagnosis of grade I, II, or IIIa follicular lymphoma (FL), treatment-naïve, stage III-IV disease, and meeting treatment criteria (GELF criteria);\n6. Measurable and\u002For evaluable lymphoma lesions;\n7. Adequate bone marrow reserve: absolute neutrophil count (ANC) \\>1.0×10⁹\u002FL or platelets \\>75×10⁹\u002FL, unless cytopenia is deemed related to bone marrow infiltration by lymphoma and the investigator believes it may recover;\n8. 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;\n9. Creatinine clearance ≥30 mL\u002Fmin (calculated by Cockcroft-Gault formula);\n10. Ability to comply with study visit schedules and other protocol requirements;\n11. 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.\n\nExclusion Criteria:\n\n1. Grade IIIb FL or transformed FL;\n2. Received lymphoma-directed therapy within 2 weeks prior to enrollment;\n3. Any severe medical condition, including but not limited to:\n\n   * 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);\n   * Uncontrolled congestive heart failure (NYHA class 3 \\[moderate\\] or 4 \\[severe\\]) within 6 months prior to screening;\n   * Left ventricular ejection fraction (LVEF) \\\u003C50%;\n   * Symptomatic coronary artery disease (e.g., chest pain, palpitations, fatigue) or requiring medication;\n   * Severe bradycardia (heart rate \\\u003C40 bpm), hypotension, dizziness, or syncope; patients with arrhythmia history require cardiac evaluation;\n   * 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;\n   * Moderate to severe liver disease (Child-Pugh B or C);\n   * Active bleeding within 2 months before screening or clinically significant bleeding tendency per investigator judgment;\n   * Pulmonary conditions impairing function (e.g., pulmonary fibrosis, drug-induced pneumonitis) deemed intolerable by the investigator;\n   * Any psychiatric or cognitive impairment that may compromise understanding of informed consent, protocol compliance, or study adherence;\n4. Known active hepatitis C virus (HCV) infection; other acquired\u002Fcongenital immunodeficiency disorders, including HIV infection;\n5. Central nervous system (CNS) involvement by lymphoma;\n6. Diagnosis or treatment for malignancies other than lymphoma, except:\n\n   * Malignancies treated with curative intent and no evidence of disease for ≥5 years before enrollment;\n   * Adequately treated basal cell carcinoma (excluding melanoma) with no evidence of disease;\n   * Adequately treated cervical carcinoma in situ with no evidence of disease;\n7. Hypersensitivity to any study drug;\n8. Pregnant or breastfeeding women;\n9. History of stroke or intracranial hemorrhage within 6 months before enrollment;\n10. Requiring anticoagulation with warfarin or equivalent vitamin K antagonists;\n11. Requiring chronic use of strong CYP3A inhibitors;\n12. Administration of live attenuated vaccines within 4 weeks before study entry.","ALL","18 Years","75 Years",{"count":61,"type":62},15,"ESTIMATED","INTERVENTIONAL",[65],"NA","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.\n\nPatients 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\u002Fm²: 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.\n\nTreatment is discontinued after 6 cycles, with no subsequent maintenance therapy.\n\nPrimary 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.",[68,69],"Follicular Lymphoma","Treatment Naive",[71,72,73,9,69],"Follicular lymphoma","fixed-duration","zanubrutinib","2025-08-15",{"date":76,"type":77},"2025-08-17","ACTUAL",{"date":79,"type":77},"2025-07-15",{"date":81,"type":62},"2028-12-30",{"name":5,"class":6},1]