[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588823":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":40,"collaborators":20,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":20,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":20,"maxAge":52,"enrollmentInfo":53,"targetDuration":20,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"The First Hospital of Jilin University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Evaluation of Objective Response Rate (ORR) with RMT-EA as First-Line Treatment for PCNSL","EXPERIMENTAL","This arm evaluates the RMT-EA regimen for first-line treatment of newly diagnosed Primary Central Nervous System Lymphoma (PCNSL).\n\nPre-induction Therapy (R-M regimen):\n\nCycle 1-2 (C1-C2):\n\nRituximab (R): 375 mg\u002Fm² IV, on Day 1 Methotrexate (MTX): 3.5 g\u002Fm² IV over 3 hours, on Day 2\n\nInduction Therapy (R-MT regimen):\n\nCycle 3-6 (C3-C6):\n\nRituximab (R): 375 mg\u002Fm² IV, on Day 1 Methotrexate (MTX): 3.5 g\u002Fm² IV over 3 hours, on Day 2 Thiotepa (T): 30 mg\u002Fm² IV over 30 minutes, on Day 3\n\nConsolidation Therapy (EA regimen):\n\nCycle 7-8 (C7-C8):\n\nEtoposide (E): 5 mg\u002Fkg IV, every 12 hours on Days 1 and 2 Cytarabine (A): 2.0 g\u002Fm² IV over 2 hours, every 12 hours on Days 3 and 4 This study arm is designed to assess the Objective Response Rate (ORR), as well as the safety, efficacy, and quality of life outcomes of the RMT-EA regimen in patients with newly diagnosed PCNSL aged ≤60 years. The dosing schedules and drug combinations outlined above distinguish this arm from others in the study.",[13],"Drug: Rituximab, Methotrexate, and Thiotepa (R-MT) Induction Followed by Etoposide and Cytarabine (EA) Consolidation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Rituximab, Methotrexate, and Thiotepa (R-MT) Induction Followed by Etoposide and Cytarabine (EA) Consolidation","Pre-induction Therapy (R-M regimen):\n\nCycle 1-2 (C1-C2):\n\nRituximab (R): 375 mg\u002Fm² IV, on Day 1 Methotrexate (MTX): 3.5 g\u002Fm² IV over 3 hours, on Day 2\n\nInduction Therapy (R-MT regimen):\n\nCycle 3-6 (C3-C6):\n\nRituximab (R): 375 mg\u002Fm² IV, on Day 1 Methotrexate (MTX): 3.5 g\u002Fm² IV over 3 hours, on Day 2 Thiotepa (T): 30 mg\u002Fm² IV over 30 minutes, on Day 3\n\nConsolidation Therapy (EA regimen):\n\nCycle 7-8 (C7-C8):\n\nEtoposide (E): 5 mg\u002Fkg IV, every 12 hours on Days 1 and 2 Cytarabine (A): 2.0 g\u002Fm² IV over 2 hours, every 12 hours on Days 3 and 4",[9],null,[22],{"facility":23,"status":24,"city":25,"state":20,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Facility Name: The First Hospital of Jilin University","RECRUITING","Changchun","China","CN",{"type":29,"coordinates":30},"Point",[31,32],125.32278,43.88,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":20,"email":39},"Jin Fengyan Fengyan Jin, Professor","CONTACT","+8613844989638","fengyanjin@jlu.edu.cn",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","FengYan Jin","Clinical Professor of Hematology Department","100588823","rituximab-methotrexate-and-tepadina-induction-followed-by-etoposide-and-cytarabine-consolidation-in-primary-central-nervous-system-lymphoma-100588823",false,"NCT06946407","Rituximab, Methotrexate, and Tepadina Induction Followed by Etoposide and Cytarabine Consolidation in Primary Central Nervous System Lymphoma","A Prospective, Single-Arm Clinical Study of Rituximab, Methotrexate, and Thiotepa (R-MT) Induction Followed by Etoposide and Cytarabine (EA) Consolidation for Primary Central Nervous System Lymphoma","Inclusion Criteria:\n\n* Age ≤ 60 years, male or female\n* Histologically and immunohistochemically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) without prior treatment\n* No evidence of systemic lymphatic or hematopoietic involvement or other systemic disease, based on thorough physical examination and imaging\u002Flaboratory tests\n* Diagnosis meets criteria for Primary Central Nervous System Lymphoma (PCNSL)\n* Written informed consent obtained from the patient or their legal guardian\n* Voluntary agreement to participate in the study\n\nExclusion Criteria:\n\n* Presence of another active malignancy\n* Known history of HIV infection or diagnosis of acquired immunodeficiency syndrome (AIDS)\n* Known allergy to any of the investigational drugs or their excipients\n* Any condition that, in the opinion of the investigator, may lead to early study termination, including but not limited to:\n* Severe comorbidities\n* Significant laboratory abnormalities\n* Serious social or family circumstances affecting safety or compliance","ALL","60 Years",{"count":54,"type":55},41,"ESTIMATED","INTERVENTIONAL",[58],"NA","High-dose methotrexate (HD-MTX) remains the foundation of treatment for primary central nervous system lymphoma (PCNSL), but outcomes are suboptimal. The addition of rituximab has shown mixed results, partly due to limited blood-brain barrier penetration. The MATRix regimen (rituximab, HD-MTX, cytarabine, thiotepa) has improved survival but is associated with significant toxicity.\n\nConsolidation therapy is recommended after induction, but there is no standard approach. Preliminary data suggest that etoposide and cytarabine (EA) consolidation after rituximab-HD-MTX induction may offer improved tolerability, though relapse rates remain high.\n\nThis study evaluates the safety, efficacy, and tolerability of a novel RMT-EA regimen-rituximab, methotrexate, and thiotepa (RMT) induction followed by etoposide and cytarabine (EA) consolidation-in newly diagnosed, untreated PCNSL patients. The aim is to improve remission depth and prolong disease-free survival, especially in younger patients.",[61,62],"Primary Central Nervous System Lymphoma (PCNSL)","CNS Lymphoma Treatment",[64,65,66],"PCNSL","Induction Therapy","Consolidation Therapy","2025-04-23",{"date":69,"type":70},"2025-04-27","ACTUAL",{"date":72,"type":70},"2022-12-02",{"date":74,"type":55},"2029-12-01",{"name":42,"class":6},1]