[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100370972":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":56,"collaborators":38,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":38,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":38,"enrollmentInfo":67,"targetDuration":38,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":43,"whyStopped":38,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Beijing Mabworks Biotech Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MIL62 + Lenalidomide","EXPERIMENTAL","MIL62 plus Lenalidomide",[13,14],"Drug: Recombinant Humanized Monoclonal Antibody MIL62 Injection","Drug: Lenalidomide",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Recombinant Humanized Monoclonal Antibody MIL62 Injection","1000mg \u002Fdose for 12 cycles(28 days) and a total of 11 doses :the first Cycle(Day1,Day15), the 2nd-8th Cycles(Day 1 every cycle);the 9th-12nd Cycles (One dose every two cycles).",[9],[22],"MIL62",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Lenalidomide","Dose on days 2-22 every 28 days x 12 cycles: the starting dose is 10-mg ; Adjusted dose according to the tumor response or toxicity reaction",[9],[28],"Revlimid",[30],{"name":31,"affiliation":32,"role":33},"Yuankai Shi, MD","Cancer Institute&Hospital, Chinese Academy of Medical Sciences,Beijing","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","(+86)010-87788293",null,"syuankaipumc@126.com",[41],{"facility":42,"status":43,"city":44,"state":38,"zip":38,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Chinese Academy of Medical Sciences and Peking Union Medical College","RECRUITING","Beijing","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":38,"phoneExt":38,"email":38},"Yuankai Shi, doctor",{"type":57,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100370972","phase-1-mil62-plus-lenalidomide-for-patients-with-relapsedrefractory-indolent-non-hodgkins-lymphoma-fl-and-mzl-100370972",false,"NCT04110301","MIL62 Plus Lenalidomide for Patients With Relapsed\u002FRefractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)","A Multi-center, Open Label, Phase 1b\u002F2 Study to Study the Efficacy and Safety of MIL62 Plus Lenalidomide in Subjects With Relapsed\u002FRefractory Follicular Lymphoma or Marginal Zone Lymphoma","Inclusion Criteria:\n\n1. Adult patients, \\>=18 years of age;\n2. Patients with either histologically documented CD20-positive MZL or FL, WHO grade 1, 2 or 3a\n3. Evidence of progression or lack of response following at least 1 prior treatment\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 (unless abnormalities are related to NHL)\n7. Life expectancy \\>6 months\n8. Able and willing to provide written informed consent and to comply with the study protocol\n\nExclusion Criteria:\n\n1. Evidence ongoing transformation into aggressive NHL\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":68,"type":69},53,"ESTIMATED","INTERVENTIONAL",[72,73],"PHASE1","PHASE2","This phase 1b\u002F2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed\u002FRefractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).",[76],"Follicular Lymphoma and Marginal Zone Lymphoma",[78],"CD20 ,Follicular Lymphoma,Marginal Zone Lymphoma,MIL62","2024-11-19",{"date":81,"type":82},"2024-11-20","ACTUAL",{"date":84,"type":82},"2019-11-28",{"date":86,"type":69},"2025-05",{"name":5,"class":6},1]