[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465970":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":25,"locations":24,"responsibleParty":34,"collaborators":24,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":24,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":24,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":24,"overallStatus":55,"whyStopped":24,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":24},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Penpulimab combined with RMA was used for first-line treatment of PCNSL","EXPERIMENTAL","One course of treatment was performed every 21 days. After 3 courses, patients underwent cranial MR+ whole-body enhanced CT for disease assessment. Patients who did not achieve partial response (PR) were withdrawn, and patients who achieved PR or complete response (CR)\u002Funcertain CR (CRu) were given 3 courses of treatment.",[13],"Drug: Penpulimab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Penpulimab","Penpulimab + RMA regimen:\n\nRituximab 375 mg\u002Fm2 d0 iv Methotrexate (MTX) 3.5g\u002Fm2 drip D1 Cytarabine \\* (ARA-C) 1-2g\u002Fm2 q12H D2-3 iv Penpulimab 200 mg iv D5",[9],[21,22,23],"rituximab","Methotrexate","Cytarabine",null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"wei M xu","CONTACT","02568306034","xuwei10000@hotmail.com",{"name":32,"role":28,"phone":24,"phoneExt":24,"email":33},"haorui shen","0401shenhaorui@163.com",{"type":35,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100465970","phase-2-penpulimab-combined-with-rma-treatment-of-primary-diagnosis-of-primary-central-nervous-system-lymphoma-100465970",false,"NCT05347641","Penpulimab Combined With RMA Treatment of Primary Diagnosis of Primary Central Nervous System Lymphoma","A Single-arm, Prospective, Single-center, Phase II Clinical Study of Penpulimab Combined With RMA in the Treatment of Newly Diagnosed Primary CNS Lymphoma","Inclusion Criteria:\n\n* For initial PCNSL confirmed by pathological tissue, the diagnostic criteria were based on WHO diagnostic criteria in 2016\n* Head MR (plain scan + enhancement) performed 28 days prior to study enrollment should show the presence of at least one measurable lesion in two vertical directions (according to 2014 Lugano criteria); Or abnormal cerebrospinal fluid examination (including cerebrospinal fluid protein, cells, NGS), or ophthalmologic examination confirmed the retina, vitreous lesions\n* PS score was 0\\~4 according to ECOG\n\nExclusion Criteria:\n\n* Organs or lymph nodes outside the central nervous system are involved\n* Patients with a second primary tumor (other than non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal cancer or breast cancer that has been cured and has not recurred within 5 years)\n* Has a history of allergic disease, severe drug allergy, or is known to be allergic to any component of a macromolecular protein preparation or penpulimab injection prescription\n* Prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CTLA-4 antibody, or CAR T cell therapy (or any other antibody that acts on T cell co-stimulation or checkpoint pathways)\n* A severe acute or chronic infection requiring systemic treatment\n* The investigator believes that the subjects may have other factors that affect the efficacy or safety evaluation of the study","ALL","18 Years","75 Years",{"count":47,"type":48},23,"ESTIMATED","INTERVENTIONAL",[51],"PHASE2","To explore PFS, ORR (CR\u002FCRu+PR), OS and side effects of piamprizumab combined with RMA in newly diagnosed PCNSL, so as to clarify the value of piamprizumab combined with RMA in the first-line treatment of PCNSL patients, and to clarify the clinical and biological factors affecting the efficacy",[54],"Primary Central Nervous System Lymphoma","NOT_YET_RECRUITING","2022-04-20",{"date":58,"type":59},"2022-04-26","ACTUAL",{"date":61,"type":48},"2022-06-01",{"date":63,"type":48},"2029-06-01",{"name":5,"class":6}]