[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100426516":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":33,"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":11,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Beijing Mabworks Biotech Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide","EXPERIMENTAL",null,[13],"Drug: Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide",{"label":15,"type":16,"description":11,"interventionNames":17},"lenalinomide","ACTIVE_COMPARATOR",[18],"Drug: lenalinomide",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","The patients confirming to the eligibility criteria will receive MIL62 from cycle 1 to cycle 30 and lenalidomide from cycle 1 to cycle 18, unless either rapid disease progression or unacceptable toxicity was observed.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"The patients confirming to the eligibility criteria will receive lenalidomide for 18 cycles, unless either rapid disease progression or unacceptable toxicity was observed.",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Yuankai Shi, doctor","CONTACT","8610-87788293","syuankaipumc@126.com",[34],{"facility":35,"status":36,"city":37,"state":11,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Chinese Academy of Medical Sciences and Peking Union Medical College","RECRUITING","Beijing","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},[47],{"name":29,"role":30,"phone":11,"phoneExt":11,"email":11},{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100426516","phase-3-mil62-combined-with-lenalidomide-versus-lenalidomide-for-patients-with-rituximab-refractory-follicular-lymphoma-100426516",false,"NCT04834024","MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma","A Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of MIL62 Plus Lenalidomide Versus Lenalidomide in Subjects With Follicular Lymphoma Refractory to Rituximab","Inclusion Criteria:\n\n1. Adult patients, \\>=18 years of age;\n2. Patients with either histologically documented CD20-positive FL, WHO grade 1, 2 or 3a\n3. Evidence of refractory to rituximab\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n5. At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter \\> 1.5 cm and a short axis ≥ 10mm\n6. Adequate hematologic function\n7. Life expectancy \\>5 years\n8. Able and willing to provide written informed consent and to comply with the study protocol\n\nExclusion Criteria:\n\n1. Evidence of refractory to lenalinomide\n2. Central nervous system lymphoma\n3. Patients with progressive multifocalleukoencephalopathy (PML)\n4. Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start\n5. Prior use of any anti-cancer vaccine\n6. Prior administration of radiotherapy 42 days prior to study entry\n7. Prior administration of chemotherapy 28 days prior to study entry\n8. History of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix\n9. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy\n10. Known hypersensitivity to thalidomide or lenalidomide\n11. Regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to \\\u003C 20 mg\u002Fday prednisone\n12. Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)\n13. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )\n14. Pregnant or lactating females","ALL","18 Years",{"count":60,"type":61},168,"ESTIMATED","INTERVENTIONAL",[64],"PHASE3","This phase III trial aims to compare the efficacy and safety of MIL62 combined lenalidomide and lenalidomide alone to treat patient diagnosed with Follicular Lymphoma (FL) and refractory to rituximab. The study randomized patients with a 1:1 ratio to receive either MIL62 plus lenalidomide or lenalidomide.",[67],"Follicular Lymphoma and Marginal Zone Lymphoma","2024-11-19",{"date":70,"type":71},"2024-11-20","ACTUAL",{"date":73,"type":71},"2021-06-02",{"date":75,"type":61},"2025-03",{"name":5,"class":6},1]