[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615941":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":69,"collaborators":21,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":21,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":60,"whyStopped":21,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Induction therapy of ZGR, and maintenance therapy of ZR","EXPERIMENTAL","Induction therapy: All enrolled patients received the ZGR regimen (zanubrutinib, obinutuzumab, and lenalidomide) for Cycles 1-4. Tumor response was assessed after Cycle 4. Patients achieving complete response (CR) or partial response (PR) continued the same ZGR regimen for 2 additional cycles (Cycles 5-6).\n\nMaintenance therapy: After completing induction therapy, patients with sustained CR\u002FPR initiated maintenance therapy with zanubrutinib plus lenalidomide (ZR) for 18 months (1.5 years) or until disease progression, intolerable toxicity, or trial withdrawal (whichever occurred first)",[13,14],"Drug: Induction Therapy: Zanubrutinib, obinutuzumab, lenalidomide","Drug: Maintenance therapy: Zanubrutinib, lenalidomide",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Induction Therapy: Zanubrutinib, obinutuzumab, lenalidomide","All enrolled patients received: Zanubrutinib: 160 mg twice daily, orally, on Days 1-28; Obinutuzumab: 1000 mg, intravenous infusion: Days 1, 8, and 15 of Cycle 1,on Day 1 of Cycles 2-6; Lenalidomide: 25 mg once daily, orally, on Days 1-21 of each 28-day cycle.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Maintenance therapy: Zanubrutinib, lenalidomide","Maintenance therapy consists of zanubrutinib plus lenalidomide: Zanubrutinib: 160 mg twice daily, orally, on Days 1-28.Lenalidomide: 25 mg every other day, orally, on Days 1-21 of each 28-day cycle",[9],[27],{"name":28,"affiliation":5,"role":29},"Shuhua Yi","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":21,"email":35},"Shuhua Yi, Dr","CONTACT","+86-022-23909106","yishuhua@ihcams.ac.cn",{"name":37,"role":33,"phone":34,"phoneExt":21,"email":38},"Rui Lyu","lvrui@ihcams.ac.cn",[40,58],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin, Tianjin 300020","NOT_YET_RECRUITING","Tianjin","Tianjin Municipality","300020","China","CN",{"type":49,"coordinates":50},"Point",[51,52],117.17667,39.14222,{"lat":52,"lon":51},[55],{"name":37,"role":33,"phone":56,"phoneExt":21,"email":57},"02223909095","ec@ihcams.ac.cn",{"facility":59,"status":60,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences","RECRUITING",{"type":49,"coordinates":62},[51,52],{"lat":52,"lon":51},[65],{"name":66,"role":33,"phone":67,"phoneExt":21,"email":68},"Yuting Yan","13820706239","yanyuting@ihcams.ac.cn",{"type":70,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100615941","phase-2-zanubrutinib-obinutuzumab-combined-with-lenalidomide-zgr-for-the-treatment-of-untreated-follicular-lymphoma-100615941",false,"NCT07299149","Zanubrutinib, Obinutuzumab Combined With Lenalidomide (ZGR) for the Treatment of Untreated Follicular Lymphoma","A Prospective, Open-label, Single-arm Multicenter Clinical Study of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Untreated Follicular Lymphoma","ZGR in TN FL","Inclusion Criteria:\n\n* Gender: No restrictions; age ≥18 years.\n* Diagnosis: Histologically confirmed CD20-positive follicular lymphoma (FL), Grade 1, 2, or 3A, per 2016 WHO classification. All patients must provide sufficient archived or fresh tumor tissue samples for immunohistochemical (IHC) analysis.\n* Disease Stage \\& Treatment Need:\n* Stage III or IV disease, or Stage II with bulky disease, meeting at least one of the following criteria:\n* a) Bulky disease: Lymph node or extranodal (excluding spleen) mass with maximum diameter ≥7 cm.\n* b) Local symptoms or organ dysfunction due to progressive lymphadenopathy or extranodal tumor mass.\n* c) B symptoms (fever, night sweats, or unintentional weight loss \\>10% of body weight within ≤6 months).\n* d) Symptomatic extranodal involvement (e.g., pleural\u002Fperitoneal effusion).\n* e) Cytopenias due to bone marrow infiltration (hemoglobin \\\u003C10 g\u002FdL, absolute neutrophil count \\[ANC\\] \\\u003C1.0×10⁹\u002FL, platelets \\\u003C100×10⁹\u002FL).\n* f) Involvement of ≥3 lymph nodes, each ≥3 cm in diameter.\n* g) Symptomatic splenomegaly.\n* Prior Therapy: No prior systemic therapy for FL.\n* ECOG Performance Status: ≤2.\n* Measurable Disease: At least one measurable lesion (\\>2 cm in longest diameter by CT\u002FMRI).\n* Life Expectancy: ≥6 months.\n* Adequate Organ Function:\n* a) ANC ≥1.0×10⁹\u002FL (without growth factor support).\n* b) Platelets ≥50×10⁹\u002FL (untransfused within 7 days).\n* c) Total bilirubin (TBIL) ≤1.5×ULN.\n* d) ALT\u002FAST ≤3×ULN.\n* e) Creatinine clearance ≥30 mL\u002Fmin (calculated by modified Cockcroft-Gault formula).\n* Contraception: Men and women of childbearing potential must agree to use highly effective contraception during the study and for 4 weeks after treatment discontinuation.\n* Informed Consent: Patients must voluntarily participate and sign informed consent forms (ICF).\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria will be excluded from this study:\n* Histologic evidence of central nervous system (CNS) lymphoma, leptomeningeal lymphoma, or transformation to high-grade lymphoma (e.g., diffuse large B-cell lymphoma, DLBCL).\n* Grade 3B follicular lymphoma (FL) or transformed FL.\n* Ann Arbor Stage I FL.\n* Prior history of malignancy, unless the patient has been disease-free for ≥5 years and the treating physician deems the risk of recurrence low (exceptions: non-melanoma skin cancer, cured localized prostate cancer, carcinoma in situ of the cervix, or squamous intraepithelial lesions on PAP smear).\n* Use of any investigational drugs, antibiotics, or participation in another interventional clinical trial within 4 weeks prior to enrollment.\n* Major surgery (excluding lymph node biopsy) within 14 days before enrollment or anticipated need for major surgery during the study.\n* Prior treatment with zanubrutinib, obinutuzumab, or lenalidomide.\n* Immunodeficiency or autoimmune disease history, or chronic systemic steroid therapy (\\>10 mg\u002Fday prednisone equivalent) or immunosuppressive therapy within 7 days before enrollment.\n* Severe hepatic dysfunction (including severe jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome), cachexia, or multi-organ failure with renal impairment.\n* Clinically significant cardiovascular abnormalities:\n* NYHA Class III\u002FIV heart failure\n* Myocardial infarction within 6 months before enrollment, Malignant arrhythmias (including QTc ≥480 ms), Uncontrolled hypertension (Systolic blood pressure (SBP) ≥150 mmHg and diastolic blood pressure (DBP) ≥100 mmHg), Unstable angina.\n\nActive infections:\n\n* HIV, active hepatitis B\u002FC infection (HBV DNA ≥2000 IU\u002FmL or HCV RNA detectable)\n* Uncontrolled systemic infections.\n* Bleeding disorders or coagulation abnormalities, or thrombotic events within 3 months.\n* Severe hypersensitivity to the active ingredients or excipients of the study drugs.\n* Pregnancy, lactation, or unwillingness to use effective contraception in women of childbearing potential.\n* Other conditions deemed unsuitable by the investigator.","ALL","18 Years","90 Years",{"count":83,"type":84},34,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","This study is planned to prospectively evaluates the efficacy and safety of the zanubrutinib, obinutuzumab, and lenalidomide (ZGR) combination regimen in treatment-naïve follicular lymphoma (FL) patients in a Chinese population.",[90],"Follicular Lymphoma",[92,93,94,95],"follicular lymphoma","zanubrutinib","Obinutuzumab","lenalidomide","2026-05-10",{"date":98,"type":99},"2026-05-13","ACTUAL",{"date":101,"type":99},"2025-12-25",{"date":103,"type":84},"2030-12-25",{"name":5,"class":6},2]