上海BGB-11417薄膜包衣片III期临床试验-一项比较 Sonrotoclax 联合奥妥珠单抗或 Sonrotoclax 联合利妥昔单抗与维奈克拉联合利妥昔单抗治疗复发和/或难治性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者的无进展生存期的研究

登记号	CTR20254444	试验状态	进行中
申请人联系人	李越	首次公示信息日期	2025-11-11
申请人名称	百济神州（苏州）生物科技有限公司

登记号	CTR20254444
相关登记号	暂无
药物名称	BGB-11417薄膜包衣片
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	慢性淋巴细胞白血病/小淋巴细胞淋巴瘤
试验专业题目	一项在复发/难治性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者中比较 Sonrotoclax 联合抗 CD20 抗体与维奈克拉联合利妥昔单抗的 3 期、随机、开放性、多中心研究
试验通俗题目	一项比较 Sonrotoclax 联合奥妥珠单抗或 Sonrotoclax 联合利妥昔单抗与维奈克拉联合利妥昔单抗治疗复发和/或难治性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者的无进展生存期的研究
试验方案编号	BGB-11417-303/CLL-RR1	方案最新版本号	方案修订案 1.0 版/CHN-1
版本日期:	2025-06-03	方案是否为联合用药	是

申请人名称	[["百济神州（苏州）生物科技有限公司"]]
联系人姓名	李越	联系人座机	4008203-159	联系人手机号
联系人Email	Clinicaltrials@beonemed.com	联系人邮政地址	北京市-北京市-昌平区中关村生命科学园，科学院路30号	联系人邮编	102206

本研究的主要目的是比较Sonrotoclax联合奥妥珠单抗与维奈克拉联合利妥昔单抗治疗复发和/或难治性（R/R）慢性淋巴细胞白血病/小淋巴细胞淋巴瘤 （CLL/SLL）患者的有效性。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	开放	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["签署ICF时，患者的年龄必须≥ 18岁。"],["根据 iwCLL 标准确诊为 CLL/SLL。既往根据 iwCLL 标准已确诊为 CLL 或 SLL 的患者可以入组。"],["患者既往必须接受过≥ 1 线 CLL/SLL 治疗。每一线治疗定义为患者必须接受该治疗已达到至少 2 个周期。"],["对于接受过BCL2i 治疗的患者，只有在一线治疗中接受过固定疗程的BCL2i治疗、 缓解持续时间≥ 3 年且最近一次 BCL2i 治疗的日期距离筛选期≥ 2 年的 CLL/SLL 患者可以入组。"],["ECOG 体能状态评分为 0、1 或 2。"],["良好的器官功能。"]]
排除标准	[["已知患有活动性幼淋巴细胞白血病或目前怀疑发生 Richter 转化（临床怀疑转化的患者可能需进行活检来排除转化）。"],["3 个月内接受过自体干细胞移植；或 3 个月内接受过嵌合抗原受体 T 细胞（CAR-T） n输注治疗。注：对于接受过自体干细胞移植或 CAR-T 治疗的患者，如果自移植或细胞输注已超过 3 个月且无明确并发症，则可以入组。"],["既往接受过同种异体干细胞移植且患有活动性移植物抗宿主病（GVHD），或需要使用免疫抑制药物治疗GVHD，或在知情同意前4 周内接受过钙调磷酸酶抑制剂治疗。"],["已知 CLL/SLL 浸润中枢神经系统。"],["重度或衰竭性肺部疾病，定义为肺一氧化碳弥散量< 60%和/或需要辅助通气的呼吸衰竭。"],["有临床意义的心血管疾病。"]]

试验药

[["中文通用名:BGB-11417薄膜包衣片 英文通用名:Sonrotoclax 商品名称:NA","剂型:NA 规格:NA 用法用量:NA 用药时程:NA"],["中文通用名:奥妥珠单抗注射液 英文通用名:ObinutuzumabInjection 商品名称:佳罗华","剂型:NA 规格:NA 用法用量:NA 用药时程:NA"],["中文通用名:利妥昔单抗注射液 英文通用名:RituximabInjection 商品名称:美罗华","剂型:NA 规格:NA 用法用量:NA 用药时程:NA"]] 序号 名称 用法

对照药

[["中文通用名:利妥昔单抗注射液 英文通用名:RituximabInjection 商品名称:美罗华","剂型:静脉注射液 规格:100mg（10mL）/瓶 用法用量:静脉输注给药，持续6个周期（第2周期第1天：375mg/m2，后续每个周期[第3周期至第7周期]第1天：500mg/m2） 用药时程:6个周期（约6个月）"],["中文通用名:利妥昔单抗注射液 英文通用名:RituximabInjection 商品名称:美罗华","剂型:静脉注射液 规格:500mg（50mL）/瓶 用法用量:静脉输注给药，持续6个周期（第2周期第1天：375mg/m2，后续每个周期[第3周期至第7周期]第1天：500mg/m2） 用药时程:6个周期（约6个月）"],["中文通用名:维奈克拉 英文通用名:Venclexta 商品名称:唯可来","剂型:片剂 规格:50mg/片 用法用量:400mg口服给药，每日一次 用药时程:25个周期（约25个月）"],["中文通用名:维奈克拉 英文通用名:Venclexta 商品名称:唯可来","剂型:片剂 规格:10mg/片 用法用量:400mg口服给药，每日一次 用药时程:25个周期（约25个月）"],["中文通用名:维奈克拉 英文通用名:Venclexta 商品名称:唯可来","剂型:片剂 规格:100mg/片 用法用量:400mg口服给药，每日一次 用药时程:25个周期（约25个月）"]] 序号 名称 用法

主要终点指标及评价时间

[["无进展生存期（PFS）","最长大约51个月","有效性指标"]] 序号 指标 评价时间 终点指标选择

次要终点指标及评价时间

[["基于BIRC 和研究者评估结果确定的无进展生存期（PFS）","最长大约69个月","有效性指标"],["基于流式细胞术检测的微小残留病（uMRD4）率","最长大约12个月","有效性指标"],["完全缓解/完全缓解伴造血功能不完全恢复（CR/CRi）率","最长大约25个月","有效性指标"],["总生存期（OS）","最长大约84个月","有效性指标"],["基于研究者和BIRC评估结果确定的总缓解率（ORR）","最长大约25个月","有效性指标"],["基于研究者和BIRC评估结果确定的缓解持续时间（DOR）","最长大约69个月","有效性指标"],["基于研究者和BIRC评估结果确定的至缓解时间（TTR）","最长大约25个月","有效性指标"],["至下一线抗 CLL/SLL 治疗的时间（TTNT）","最长大约84个月","有效性指标"],["欧洲癌症研究与治疗组织生活质量问卷-CLL模块","基线和最长大约69个月","有效性指标"],["欧洲癌症研究与治疗组织生活质量问卷- 核心 30（EORTC-QLQ-C30）","基线和最长大约69个月","有效性指标"],["出现TEAE和SAE的受试者人数","最长大约26个月","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	刘澎	学位	医学博士	职称	主任医师
	电话	021-64041990	Email	Liu.peng@zs-hospital.sh.cn	邮政地址	上海市-上海市-徐汇区枫林路180号
	邮编	200032	单位名称	复旦大学附属中山医院

[["复旦大学附属中山医院","刘澎","中国","上海市","上海市"],["南方医科大学南方医院","郭绪涛","中国","广东省","广州市"],["江苏省苏北人民医院","孙梅","中国","江苏省","扬州市"],["四川大学华西医院","邹立群","中国","四川省","成都市"],["中南大学湘雅医院","傅敢","中国","湖南省","长沙市"],["厦门大学附属第一医院","徐兵","中国","福建省","厦门市"],["辽宁省肿瘤医院","邢晓静","中国","辽宁省","沈阳市"],["江西省肿瘤医院","黄燕","中国","江西省","南昌市"],["中日友好医院","李振玲","中国","北京市","北京市"],["东南大学附属中大医院","葛峥","中国","江苏省","南京市"],["山东省立医院","周香香","中国","山东省","济南市"],["内蒙古医科大学附属医院","高大","中国","内蒙古自治区","呼和浩特市"],["福州大学附属省立医院","刘振华","中国","福建省","福州市"],["青岛大学附属医院","赵霞","中国","山东省","青岛市"],["浙江省台州医院","郭群依","中国","浙江省","台州市"],["江南大学附属医院","华海应","中国","江苏省","无锡市"],["陕西省人民医院","王一","中国","陕西省","西安市"],["福建医科大学附属协和医院","许贞书","中国","福建省","福州市"],["中国医学科学院血液病医院","易树华","中国","天津市","天津市"],["宁波大学附属人民医院","陆滢","中国","浙江省","宁波市"],["广州市第一人民医院","王顺清","中国","广东省","广州市"],["苏州市立医院","何广胜","中国","江苏省","苏州市"],["广西医科大学附属肿瘤医院","岑洪","中国","广西壮族自治区","南宁市"],["济宁市第一人民医院","赵同峰","中国","山东省","济宁市"],["SWEDISH MEDICAL CENTER - SWEDISH CANCER INSTITUTE - FIRST HILL CAMPUS","FARAH RAFIC","United States","Washington","Seattle"],["ROYAL CORNWALL HOSPITALS NHS TRUST","FURTADO RAFIC","United Kingdom","Cornwall","Truro"],["DANA-FARBER CANCER INSTITUTE","DAVIDS MATTHEW","United States","Massachusetts","Boston"],["MEMORIAL SLOAN KETTERING CANCER CENTER MSKCC","THOMPSON MEGHAN","United States","New Mexico","New York"],["MAYO CLINIC ROCHESTER","PARIKH SAMEER","United States","Minnesota","Rochester"],["YALE UNIVERSITY, YALE CANCER CENTER","HUNTINGTON SCOTT","United States","Connecticut","New Haven"],["CHAO FAMILY COMPREHENSIVE CANCER CENTER","COOMBS CATHERINE","United States","California","Orange"],["NORTHWESTERN UNIVERSITY","MA SHUO","United States","Illinois","Chicago"],["THOMAS JEFFERSON UNIVERSITY","WYSOTA MICHAEL","United States","Pennsylvania","Philadelphia"],["ROCKY MOUNTAIN CANCER CENTERS (WILLIAMS) - USOR","BURKE JOHN","United States","Colorado","Aurora"],["ILLINOIS CANCER SPECIALISTS (NILES) - USOR","ELMS DESTRY","United States","Illinois","Niles"],["TEXAS ONCOLOGY - SAN ANTONIO MEDICAL CENTER - USOR","FRIEDMAN DAVID","United States","Texas","San Antonio"],["ONCOLOGY ASSOCIATES OF OREGON - WILLAMETTE VALLEY CANCER CENTER","SHARMAN JEFFREY","United States","Oregon","Eugene"],["UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL","STEPHENS DEBORAH","United States","North Carolina","Chapel Hill"],["UPMC HILLMAN CANCER CENTER(UNIV OF PITTSBURGH)","HOU JINGZHOU","United States","Pennsylvania","Pittsburgh"],["PENN STATE MILTON S HERSHEY MEDICAL CENTER","CIOCCIO JOSEPH","United States","Pennsylvania","Hershey"],["CLINICAL RESEARCH ALLIANCE, INC.","D'OLIMPIO JAMES","United States","New York","WESTBURY"],["LEVINE CANCER CENTER","JACOBS RYAN","United States","North Carolina","Charlotte"],["MISSION CANCER AND BLOOD","GRAFF TARA","United States","Iowa","Waukee"],["SCRIPPS PREBYS CANCER CENTER","XAVIER MARIN","United States","California","San Diego"],["MARY BIRD PERKINS CANCER CENTER","DALOVISIO ANDREW","United States","Louisiana","Baton Rouge"],["UNIVERSITY OF MARYLAND GREENEBAUM COMPREHENSIVE CANCER CENTER","KLINE KATHRYN","United States","Maryland","Baltimore"],["STANFORD CANCER INSTITUTE","FAKHRI BITA","United States","California","Palo Alto"],["NORTHWEST CANCER SPECIALIST, P.C.(US ONCOLOGY RESEARCH)","BICE TRISTAN","United States","Washington","Vancouver"],["TEXAS ONCOLOGY-BAYLORCHARLES A. SAMMONS CANCER CENTER","LEVY YAIR","United States","Texas","Dallas"],["TEXAS ONCOLOGY -TYLER","YIMER HABTE","United States","Texas","Tyler"],["TENNESSEE ONCOLOGY","BYRNE MICHAEL","United States","Tennessee","Nashville"],["ONCOLOGY HEMATOLOGY CARE CLINICAL TRIALS, LLC","MUKHERJEE AKASH","United States","Ohio","Cincinnati"],["EASTERN CONNECTICUT HEMATOLOGY AND ONCOLOGY","SLATER DENNIS","United States","Connecticut","Norwich"],["THE CANCER AND HEMATOLOGY CENTERS","BRINKER BRETT","United States","Michigan","Grand Rapids"],["UNIVERSITY OF LOUISVILLE, BROWN CANCER CENTER","HEGAZI MOHAMED MOHAMED","United States","Kentucky","Louisville"],["CROSS CANCER INSTITUTE","STERRETT MOHAMED","Canada","Alberta","Edmonton"],["BRITISH COLUMBIA CANCER AGENCY - THE VANCOUVER CENTRE","GERRIE ALINA","Canada","British Columbia","Vancouver"],["CHU DE QUEBEC - UNIVERSITE LAVAL, HOPITAL DE L'ENFANT-JESUS, CENTRE INTEGRE DE CANCEROLOGIE (CIC)","LAROUCHE JEAN-FRANCOIS","Canada","Quebec","Quebec"],["PRINCESS MARGARET CANCER CENTRE","VIJENTHIRA ABIRAMI","Canada","Ontario","Toronto"],["THE OTTAWA HOSPITAL","AW ANDREW","Canada","Ontario","Ottawa"],["NEWFOUNDLAND AND LABRADOR HEALTH SERVICES","COSTELLO JACQUELINE","Canada","Newfoundland and Labrador","St John's"],["CIUSSS NIM HSCM","CHAMPAGNE JEAN-NICOLAS","Canada","Quebec","Montreal"],["CANCERCARE MANITOBA","BANERJI VERSHA","Canada","Manitoba","Winnipeg"],["ARTHUR J.E. CHILD COMPREHENSIVE CANCER CENTRE","OWEN CAROLYN","Canada","Alberta","Calgary"],["RIJNSTATE","VAN DER SPEK ELLEN","Netherlands","Gelderland","Arnhem"],["ALBERT SCHWEITZER ZIEKENHUIS","LEVIN MARK-DAVID","Netherlands","Zuid-Holland","DORDRECHT"],["FLEVOZIEKENHUIS","KATER ARNON P.","Netherlands","Flevoland","ALMERE"],["TERGOOI MC","DE WEERD ESTHER","Netherlands","Noord-Holland","Hilversum"],["CLINIQUES UNIVERSITAIRES SAINT LUC","BAILLY SARAH","Belgium","Brussels","Brussels"],["UZ ANTWERPEN","VANDERKERKEN MATTHIAS","Belgium","Antwerpen","Edegem"],["UNIVERSITY HOSPITALS LEUVEN","JANSSENS ANN","Belgium","Vlaams-Brabant","Leuven"],["CHU HOPITAL LYON SUD","FERRANT EMMANUELLE","France","Rhone","Pierre-Benite"],["HOPITAL DE LA PITIE-SALPETRIERE","ROOS-WEIL DAMIEN","France","Paris","Paris"],["HOPITAL ROBERT DEBRE","QUINQUENEL ANNE","France","Marne","REIMS"],["CENTRE HOSPITALIER UNIVERSITAIRE NANTES-HOTEL DIEU","LOK ANNE","France","Loire-Atlantique","NANTES"],["CHU NANCY - HOPITAL BRABOIS","FEUGIER PIERRE","France","Meurthe-et-Moselle","Vandoeuvre-les-Nancy"],["CENTRE HENRI-BECQUEREL","LEPRETRE STEPHANE","France","LEPRETRE STEPHANE","Rouen Cedex 1"],["IUCT ONCOPOLE","YSEBAERT LOiC","France","Haute-Garonne","TOULOUSE"],["CHU RENNES","DE GUIBERT SOPHIE","France","Ille-et-Vilaine","Rennes Cedes 9"],["CHU CLERMONT FERRAND - THERAPIE CELLULAIRE AND HEMATOLO","GUIEZE ROMAIN","France","Puy-de-Dome","CLERMONT-FERRAND"],["HOSPITAL DE LA PRINCESA","LOSCERTALES JAVIER","Spain","Madrid","MADRID"],["ICO L'HOSPITALET - HOSPITAL DURAN I REYNALS","OLIVEIRA RAMOS ANA CARLA","Spain","Barcelona","L'HOSPITALET DE LLOBREGAT"],["HOSPITAL UNIVERSITARIO MARQUES DE VALDECILLA","YANEZ LUCRECIA","Spain","Cantabria","Santander"],["HOSPITAL CLINIC DE BARCELONA","MOZAS PABLO","Spain","Barcelona","Barcelona"],["HOSPITAL UNIVERSITARIO DE SALAMANCA","RAMON CRISTINA","Spain","Salamanca","Salamanca"],["VALL D HEBRON INSTITUTE OF ONCOLOGY - VHIO","BOSCH FRANCESC","Spain","Barcelona","Barcelona"],["HOSPITAL UNIVERSITARIO INFANTA LEONOR","HERNANDZ RIVAS JOSE ANGEL","Spain","Madrid","Madrid"],["COSTA DEL SOL (MARBELLA, MALAGA)","MEDINA ANGELES","Spain","Malaga","Marbella"],["HOSPITAL VIRGEN DE VALME (SEVILLA)","RIOS EDURADO","Spain","Sevilla","Sevilla"],["UNIVERSITA DEGLI STUDI DI MODENA-AZIENDA OSPEDALIERE POLICLINCO","MARASCA ROBERTO","Italy","Modena","Modena"],["AO BROTZU - OSPEDALE ONCOLOGICO ARMANDO BUSINCO","MURRU ROBERTA","Italy","Cagliari","Cagliari"],["OSPEDALE SAN RAFFAELE","GHIA PAOLO","Italy","Milano","Milano"],["AZIENDA SOCIO SANITARIA TERRITORIALE","FRUSTACI ANNA MARIA","Italy","Milano","Milano"],["AZIENDA OSPEDALIERA POLICLINICO DI BARI","MUSTO PELLEGRINO","Italy","Bari","Bari"],["AZIENDA OSPEDALIERO UNIVERSITARIA POLICLINICO - VITTORIO EMANUELE","CHIARENZA ANNALISA","Italy","Catania","Catania"],["AZIENDA OSPEDALIERO-UNIVERSITARIA DI FERRARA","RIGOLIN GIAN MATTEO","Italy","FERRARA","FERRARA"],["ASL SALERNO ANDREA TORTORA","LUCIGNANO MARIANO","Italy","Salerno","Pagani"],["MEDIZINISCHE UNIVERSITATSKLINIK INNSBRUCK","BOHN JAN-PAUL","Austria","Tyrol","Innsbruck"],["MEDICAL UNIVERSITY VIENNA ONCOLOGY","GAIGER JAN-PAUL JAN-PAUL","Austria","Wien","Wien"],["HANUSCH KRANKENHAUS","RATHKOLB VICTOR","Austria","Wien","Wien"],["CHURCHILL HOSPITAL - OXFORD UNIVERSITY HOSPITAL NHS TRUST","EYRE TOBY","United Kingdom","Oxfordshire","Headington"],["ST JAMES'S UNIVERSITY HOSPITAL","MUNIR TALHA","United Kingdom","West Yorkshire","Leeds"],["CLATTERBRIDGE CANCER CENTRE","WILLIAMS STELLA","United Kingdom","Merseyside","Wirral"],["KING'S COLLEGE HOSPITAL","PATTEN PIERS","United Kingdom","London","London"],["FREEMAN HOSPITAL","MARR HELEN","United Kingdom","Tyne and Wear","NewCastle Upon Tyne"],["UNIVERSITY HOSPITALS DORSET - ROYAL BOURNEMOUTH HOSPITAL","WALEWSKA RENATA","United Kingdom","Dorset","Bournemouth"],["RIGSHOSPITALET","DA CUNHA-BANG CASPAR","Denmark","Copenhagen","Copenhagen"],["MONASH HEALTH","OPAT","Australia","Victoria","Clayton"],["PETER MACCALLUM CANCER CENTRE","ANDERSON","Australia","Victoria","Melbourne"],["PRINCESS ALEXANDRA HOSPITAL","HANDUNNETTI","Australia","Queensland","Woolloongabba"],["ST GEORGE HOSPITAL","BADOUX","Australia","New South Wales","Kogarah"],["ST VINCENT'S HOSPITAL MELBOURNE","LASICA","Australia","Victoria","Fitzroy"],["THE ALFRED HOSPITAL","TAM","Australia","Victoria","Melbourne"],["BLACKTOWN CANCER AND HAEMATOLOGY CENTRE","FALCONER","Australia","New South Wales","BLACKTOWN"],["PERTH BLOOD INSTITUTE","ALWAN","Australia","Western Australia","WEST PERTH"],["SUNSHINE COAST HOSPITAL AND HEALTH SERVICE","ORCHARD","Australia","Queensland","BIRTINYA"],["GENESISCARE NORTH SHORE","KLIMAN","Australia","New South Wales","ST LEONARDS"],["MACQUARIE UNIVERSITY","WOJTOWICZ","Australia","New South Wales","Kogarah"],["ROCKINGHAM HOSPITAL","CHIN","Australia","Western Australia","Perth"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["复旦大学附属中山医院医学伦理委员会","同意","2025-07-25"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 95 ； 国际: 630 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 17 ；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：2025-06-11；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2025-06-30；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；