[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419143":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":43,"centralContacts":49,"locations":58,"responsibleParty":79,"collaborators":53,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":53,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":53,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":61,"whyStopped":53,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RL-MT","EXPERIMENTAL","Induction Chemotherapy: Rituximab, 375mg\u002Fm2, Intravenous administration on day 0, Lenalidomide, 25mg oral administration on day 1 to 10, combined with regimen: Methotrexate, 3mg\u002Fm2, Intravenous administration (pumping for 3h) on day 1 of each 3-week cycle, Temozolomide, 150mg\u002Fm2\u002Fd oral administration on day 1 to 10.\n\nConsolidation Treatment: Autologous hematopoietic stem cell transplantation or reduced whole brain radiotherapy after high-dose chemotherapy.\n\nMaintenance Treatment: Lenalidomide, 10mg oral administration on day 1 to 21 of each 4-week cycle for 12 months.",[13,14,15,16],"Drug: Rituximab","Drug: Lenalidomide","Drug: Methotrexate","Drug: Temozolomide",[18,25,31,37],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Rituximab","Induction Chemotherapy: 375mg\u002Fm2, Intravenous administration on day 0 of each 3-week cycle until disease progression\u002Fstable disease or unacceptable toxicity develops, up to 6 cycles.",[9],[24],"RiTUXimab Injection",{"type":19,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Lenalidomide","Induction Chemotherapy: 25mg, oral administration on day 1 to 10 of each 3-week cycle until disease progression\u002Fstable disease or unacceptable toxicity develops, up to 6 cycles.\n\nMaintenance Treatment: 10mg oral administration on day 1 to 21 repeated every 4 weeks until disease progression or unacceptable toxicity develops, up to 12 cycles.",[9],[30],"Lenalidomide capsule",{"type":19,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Methotrexate","Induction Chemotherapy: 3mg\u002Fm2, Intravenous administration (pumping for 3h) on day 1 of each 3-week cycle until disease progression\u002Fstable disease or unacceptable toxicity develops, up to 6 cycles.",[9],[36],"Methotrexate Injectable Solution",{"type":19,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Temozolomide","Induction Chemotherapy: 150mg\u002Fm2\u002Fd oral administration on day 1 to 10 of each 3-week cycle until disease progression\u002Fstable disease or unacceptable toxicity develops, up to 6 cycles.",[9],[42],"Temozolomide capsule",[44,47],{"name":45,"affiliation":5,"role":46},"Zhihua Yao, M.D. Ph.D","STUDY_DIRECTOR",{"name":48,"affiliation":5,"role":46},"Yanyan Liu, M.D. Ph.D",[50,55],{"name":45,"role":51,"phone":52,"phoneExt":53,"email":54},"CONTACT","+8613592622292",null,"zlyyyaozhihua1260@zzu.edu.cn",{"name":48,"role":51,"phone":56,"phoneExt":53,"email":57},"+8613838176375","yyliu@zzu.edu.cn",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":53,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Henan Cancer Hospital\u002FThe affiliated Cancer Hospital of ZhengZhou university","RECRUITING","Zhengzhou","Henan","China","CN",{"type":67,"coordinates":68},"Point",[69,70],113.64861,34.75778,{"lat":70,"lon":69},[73,74,76,78],{"name":45,"role":51,"phone":52,"phoneExt":53,"email":54},{"name":48,"role":51,"phone":75,"phoneExt":53,"email":57},"+8613818176375",{"name":45,"role":77,"phone":53,"phoneExt":53,"email":53},"PRINCIPAL_INVESTIGATOR",{"name":48,"role":77,"phone":53,"phoneExt":53,"email":53},{"type":77,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Zhihua Yao, PhD","Director","100419143","phase-2-rituximab-lenalidomide-combined-with-methotrexate-and-temozolomide-for-primary-central-nervous-system-lymphoma-100419143",false,"NCT04737889","Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma","A Single Arm, Multi-center, Phase II Clinical Trial of Rituximab, Lenalidomide Combined With High-dose Methotrexate and Temozolomide (RL-MT) in the First-line Treatment for Patients With Primary Central Nervous System Lymphoma","Inclusion Criteria:\n\n1. Age between 18 to 70 years old (including 18 and 70)\n2. Diagnosed as primary central nervous system lymphoma (limited to the brain, spinal cord, meninges and eyeballs, without involvement of other parts)\n3. Having not received anti-tumor therapy before enrollment (except for tumor resection and biopsy and the use of glucocorticoids to reduce central nervous system symptoms)\n4. Having at least one measurable lesions\n5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)\n6. Life expectancy no less than 1 month\n7. enough main organ function\n8. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study\n9. Agreeing to sign the written informed consents\n\nExclusion Criteria:\n\n1. Diagnosed as secondary central nervous system lymphoma\n2. Diagnosed as CD20 negative large B cell primary central nervous system lymphoma\n3. Active malignant tumor need be treated at the same time\n4. Other malignant tumor history\n5. Serious surgery and trauma less than two weeks\n6. Patients with active tuberculosis\n7. Systemic therapy for serious acute\u002Fchronic infection\n8. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months\n9. HIV-positive, AIDS patients and untreated active hepatitis\n10. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months\n11. Patients with a history of mental illness or drug abuse\n12. Poor compliance during the trial and\u002For follow-up phase\n13. Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial\n14. Researchers determine unsuited to participate in this trial","ALL","18 Years","70 Years",{"count":93,"type":94},30,"ESTIMATED","INTERVENTIONAL",[97],"PHASE2","This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of Rituximab, Lenalidomide combined with high-dose Methotrexate and Temozolomide (RL-MT) in the first-line treatment for patients with primary central nervous system lymphoma.",[100],"Primary Central Nervous System Lymphoma",[100,9],"2025-04-18",{"date":104,"type":105},"2025-04-23","ACTUAL",{"date":107,"type":105},"2021-01-13",{"date":109,"type":94},"2026-01-13",{"name":5,"class":6},1]