protocolSection identificationModule nctId: NCT06319456, orgStudyIdInfo id: APG2575CC301, briefTitle: A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Ascentage Pharma Group Inc., class: INDUSTRY, descriptionModule briefSummary: This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL/SLL., conditionsModule conditions: CLL/SLL, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 344, type: ESTIMATED, armsInterventionsModule interventions name: Lisaftoclax (APG-2575), interventions name: Acalabrutinib, interventions name: Fludarabine, interventions name: Cyclophosphamide，CTX, interventions name: Rituximab, interventions name: Chlorambucil, outcomesModule primaryOutcomes measure: Progress Free Survival (PFS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Minimal Residual Disease (MRD) negativity rate, secondaryOutcomes measure: Safety evaluation based on the adverse event concurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Bengbu Medical College, status: NOT_YET_RECRUITING, city: Bengbu, state: Anhui, zip: 233004, country: China, contacts name: Yinghua Geng, Ph.D., role: CONTACT, contacts name: Yinghua Geng, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.94083, lon: 117.36083, locations facility: Guangdong Provincial People's Hospital, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510080, country: China, contacts name: Wenyu Li, Ph.D., role: CONTACT, contacts name: Wenyu Li, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Nanfang Hospital of Southern Medical University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Xutao Guo, Ph.D., role: CONTACT, contacts name: Xutao Guo, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Henan Provincial Cancer Hospital, status: RECRUITING, city: Zhengzhou, state: Henan, zip: 450003, country: China, contacts name: Keshu Zhou, M.D., Ph.D., role: CONTACT, phone: 13674902391, email: drzhouks77@163.com, contacts name: Keshu Zhou, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Hematology Hospital of the Chinese Academy of Medical Sciences, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Lugui Qiu, M.D., Ph.D., role: CONTACT, phone: 022-23909272, email: qiulg@ihcams.ac.cn, contacts name: Lugui Qiu, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False