protocolSection identificationModule nctId: NCT06290817, orgStudyIdInfo id: 2023-0724, briefTitle: Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-30, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2026-03-20, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, collaborators name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, collaborators name: Huizhou Municipal Central Hospital, collaborators name: Ningbo Medical Center Lihuili Hospital, collaborators name: Affiliated Hospital of Jiaxing University, collaborators name: The Second Affiliated Hospital of Jiaxing University, descriptionModule briefSummary: This is a prospective, multicenter, single-arm clinical study on the treatment of newly diagnosed diffuse large B-cell lymphoma with high-risk of CNS relapse defined by CNS-IPI using Orelabrutinib in combination with R-CDOP regimen., conditionsModule conditions: Diffuse Large B-cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: Orelabrutinib combined with R-CDOP regimen, outcomesModule primaryOutcomes measure: 2-year central nervous system relapse rate, secondaryOutcomes measure: Complete Response Rate, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: 2-year Overall survival (OS) rate, secondaryOutcomes measure: 1-year Overall survival (OS) rate, secondaryOutcomes measure: 2-year progression-free survival (PFS) rate, secondaryOutcomes measure: 1-year progression-free survival (PFS) rate, secondaryOutcomes measure: Occurrence of hematologic adverse events and non-hematologic adverse events according to CTCAE V4.03, otherOutcomes measure: Occurrence of adverse events and serious adverse events according to CTCAE V4.03, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Affiliated Hospital, School of Medicine, Zhejiang University, status: RECRUITING, city: Zhejiang, state: Zhejiang, country: China, contacts name: Wenbin Qian, role: CONTACT, contacts name: Xibin Xiao, role: SUB_INVESTIGATOR, locations facility: Huzhou Central Hospital, status: RECRUITING, city: Huzhou, country: China, contacts name: Lihong Shou, role: CONTACT, phone: 13362216921, email: SLH077@126.COM, geoPoint lat: 30.8703, lon: 120.0933, locations facility: Affiliated hospital of Jiaxing University, the First Hospital of Jiaxing, status: RECRUITING, city: Jiaxing, country: China, contacts name: Hui Zeng, role: CONTACT, phone: 13957330440, email: zhwuhqn@163.com, geoPoint lat: 30.7522, lon: 120.75, locations facility: Affiliated hospital of Jiaxing University, the Second Hospital of Jiaxing, status: RECRUITING, city: Jiaxing, country: China, contacts name: Beili Hu, role: CONTACT, phone: 0573-82080930, email: 87718916@qq.com, geoPoint lat: 30.7522, lon: 120.75, locations facility: Ningbo Medical Center LiHuili Hospital, status: RECRUITING, city: Ningbo, country: China, contacts name: Jing Le, role: CONTACT, phone: 13566511755, email: nblejing@aliyun.com, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Taizhou Hospital of Zhejiang, status: RECRUITING, city: Taizhou, country: China, contacts name: Yiqun Guo, role: CONTACT, phone: 13515861286, email: guoqunyi@163.com, geoPoint lat: 32.49069, lon: 119.90812, hasResults: False