[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648298":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":61,"locations":67,"responsibleParty":81,"collaborators":32,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":32,"eligibilityCriteria":90,"healthyVolunteers":87,"sex":91,"minAge":92,"maxAge":32,"enrollmentInfo":93,"targetDuration":32,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":104,"whyStopped":32,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"RO2","EXPERIMENTAL","Patients in the study group will receive six cycles of the RO2 regimen, with each cycle repeated every 21 days. Routine efficacy assessments will be performed upon completion of each cycle during treatment. PET-CT scanning will be used for efficacy evaluation after three cycles of therapy. Patients with stable disease (SD) or progressive disease (PD) will discontinue study treatment, and the investigator will determine the salvage therapy regimen. Patients achieving a complete response (CR) or partial response (PR) will continue the original regimen for cycles 4 to 6.\n\nAfter completion of six cycles of treatment, PET-CT will be conducted for efficacy reassessment. Patients with CR or PR will finish induction therapy and enter the maintenance phase. The study group will receive obinutuzumab maintenance therapy once every three months for a total of two years, combined with lenalidomide maintenance administered for 10 days per month over six months.",[13,14,15],"Drug: Orelabrutinib","Drug: obinutuzumab","Drug: Lenalidomide",{"label":17,"type":18,"description":19,"interventionNames":20},"O-Chemo","ACTIVE_COMPARATOR","Patients in the study group will receive six cycles of the O-chemo regimen, with each cycle repeated every 21 days. Routine efficacy assessments will be performed upon completion of each cycle during treatment. PET-CT scanning will be used for efficacy evaluation after three cycles of therapy. Patients with stable disease (SD) or progressive disease (PD) will discontinue study treatment, and the investigator will determine the salvage therapy regimen. Patients achieving a complete response (CR) or partial response (PR) will continue the original regimen for cycles 4 to 6.\n\nAfter completion of six cycles of treatment, PET-CT will be conducted for efficacy reassessment. Patients with CR or PR will finish induction therapy and enter the maintenance phase. The study group will receive obinutuzumab maintenance therapy once every three months for a total of two years.",[14,21,22,23,24,25],"Drug: Cyclophosphamide","Drug: Doxorubicin","Drug: Prednisone","Drug: Vincristine","Drug: Bendamustine",[27,33,37,41,45,49,53,57],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Orelabrutinib","Orelabrutinib PO will be administered as per the schedule specified in the respective arm.",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"obinutuzumab","Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.",[17,9],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Lenalidomide","Lenalidomide PO will be administered as per the schedule specified in the respective arm.",[9],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"Cyclophosphamide","Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.",[17],{"type":28,"name":46,"description":47,"armGroupLabels":48,"otherNames":32},"Doxorubicin","Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.",[17],{"type":28,"name":50,"description":51,"armGroupLabels":52,"otherNames":32},"Prednisone","Prednisone PO will be administered as per the schedule specified in the respective arm.",[17],{"type":28,"name":54,"description":55,"armGroupLabels":56,"otherNames":32},"Vincristine","Vincristine infusion will be administered as per the schedule specified in the respective arm.",[17],{"type":28,"name":58,"description":59,"armGroupLabels":60,"otherNames":32},"Bendamustine","Bendamustine infusion will be administered as per the schedule specified in the respective arm.",[17],[62],{"name":63,"role":64,"phone":65,"phoneExt":32,"email":66},"Peng-Peng Xu","CONTACT","+862164370045 Ext. 610707","pengpeng_xu@126.com",[68],{"facility":69,"status":32,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":32},"Ruijin Hosiptal","Shanghai","Shanghai Municipality","20025","China","CN",{"type":76,"coordinates":77},"Point",[78,79],121.45806,31.22222,{"lat":79,"lon":78},{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Zhao Weili","Vice President, Ruijin Hospital","100648298","phase-3-a-multicenter-prospective-open-label-randomized-controlled-clinical-study-of-orelabrutinib-combined-with-obinutuzumab-and-lenalidomide-versus-obinutuzumab-plus-chemotherapy-for-treatment-naive-follicular-lymphoma-100648298",false,"NCT07719855","A Multicenter, Prospective, Open-Label, Randomized Controlled Clinical Study of Orelabrutinib Combined With Obinutuzumab and Lenalidomide Versus Obinutuzumab Plus Chemotherapy for Treatment-Naive Follicular Lymphoma","Inclusion Criteria:\n\n1. Subjects with histopathologically confirmed follicular lymphoma (FL) Grade 1-3A;\n2. Subjects who have never received prior anti-lymphoma therapy;\n3. Age ≥ 18 years old;\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;\n5. Adequate bone marrow, hepatic and renal function, defined as:\n\n1）Absolute neutrophil count (ANC) \\> 1,000\u002FμL; platelet count \\> 50,000\u002Fmm³; hemoglobin \\> 80 g\u002FdL; 2）Alanine transaminase (ALT) and aspartate transaminase (AST) \\\u003C 3 × upper limit of normal (ULN); 3）Total serum bilirubin \\\u003C 1.5 × ULN (patients with Gilbert syndrome are eligible); serum creatinine \\\u003C 2 × ULN OR creatinine clearance \\> 50 mL\u002Fmin; 6、Tumor tissue available for testing (fresh tissue preferred; archived paraffin-embedded tissue is acceptable); 7、Women of childbearing potential with a negative pregnancy test prior to Day 1 of treatment, who agree to use effective contraception throughout the study period and for at least 1 year after completion of study treatment; 8、Written informed consent obtained from the subject or their legal authorized representative prior to any study-specific examinations or procedures.\n\nExclusion Criteria:\n\n1. Uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc.\n2. Abnormal laboratory parameters at screening (unless attributed to follicular lymphoma):\n\n   1. Absolute neutrophil count \\\u003C 1.5 × 10⁹\u002FL\n   2. Platelet count \\\u003C 80 × 10⁹\u002FL; if bone marrow involvement is present, platelet count \\\u003C 50 × 10⁹\u002FL\n   3. Alanine transaminase (ALT) or aspartate transaminase (AST) \\> 2 × upper limit of normal (ULN); alkaline phosphatase (AKP) or bilirubin \\> 1.5 × ULN\n   4. Serum creatinine \\> 1.5 × ULN OR estimated glomerular filtration rate (eGFR) \\\u003C 40 mL\u002Fmin\u002F1.73 m² (calculated via the Cockcroft-Gault equation or Modification of Diet in Renal Disease \\[MDRD\\] equation)\n3. Human immunodeficiency virus (HIV)-positive subjects.\n4. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n5. HBV screening requirements: Subjects with positive hepatitis B surface antigen (HBsAg) must undergo HBV DNA testing; those with HBV DNA \\\u003C 10³ IU\u002FmL are eligible for enrollment. Subjects with negative HBsAg but positive hepatitis B core antibody (HBcAb) (regardless of hepatitis B surface antibody \\[HBsAb\\] status) must also undergo HBV DNA testing; those with HBV DNA \\\u003C 10³ IU\u002FmL are eligible for enrollment.\n6. Receiving concurrent anti-tumor therapy (for lymphoma or other malignancies).\n7. Subjects with psychiatric disorders, or those with known\u002Fsuspected poor compliance to the study protocol.\n8. Requiring continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers (see Appendix 3). Subjects who have taken strong\u002Fmoderate CYP3A inhibitors or inducers within 7 days prior to the first dose of study drug (or within less than 5 half-lives of such medications) are excluded.\n9. History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug.\n10. Inability to swallow capsules, or presence of diseases that significantly impair gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, partial or complete intestinal obstruction.\n\nOther uncontrolled concomitant medical conditions deemed by the investigator to interfere with study participation. Any life-threatening disease, medical condition or organ dysfunction that may compromise subject safety, interfere with the absorption or metabolism of oral targeted agents, or expose study outcomes to excessive risk, as judged by the investigator.","ALL","18 Years",{"count":94,"type":95},652,"ESTIMATED","INTERVENTIONAL",[98],"PHASE3","This study intends to conduct a prospective, multicenter, open-label, randomized controlled clinical trial to systematically evaluate the efficacy and safety of the orelabrutinib plus obinutuzumab and lenalidomide (RO2) regimen versus the obinutuzumab-combined chemotherapy (O-chemo) regimen in patients with previously untreated follicular lymphoma. The primary observation is whether the RO2 regimen can maintain or improve therapeutic efficacy while significantly reducing hematological toxicities and other related adverse reactions, so as to provide a novel therapeutic option for improving the prognosis and quality of life of patients with follicular lymphoma (FL).",[101],"Follicular Lymphoma ( FL)",[103],"Follicular Lymphoma","NOT_YET_RECRUITING","2026-07-19",{"date":107,"type":108},"2026-07-22","ACTUAL",{"date":110,"type":95},"2026-07",{"date":112,"type":95},"2033-12",{"name":5,"class":6},1]