南京索托克拉III期临床试验-一项在初治慢性淋巴细胞白血病患者中比较 Sonrotoclax（BGB-11417）联合泽布替尼（BGB-3111）与维奈克拉联合阿可替尼的研究

登记号	CTR20260609	试验状态	进行中
申请人联系人	李越	首次公示信息日期	2026-02-14
申请人名称	百济神州（苏州）生物科技有限公司

登记号	CTR20260609
相关登记号	暂无
药物名称	索托克拉
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	初治慢性淋巴细胞白血病
试验专业题目	一项 Sonrotoclax（BGB-11417）联合泽布替尼（BGB-3111）对比维奈克拉联合阿可替尼用于初治慢性淋巴细胞白血病患者的 3 期、开放性、随机研究
试验通俗题目	一项在初治慢性淋巴细胞白血病患者中比较 Sonrotoclax（BGB-11417）联合泽布替尼（BGB-3111）与维奈克拉联合阿可替尼的研究
试验方案编号	BGB-11417-304	方案最新版本号	方案1.0 CHN-1
版本日期:	2025-11-07	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

本研究的目的是在初治慢性淋巴细胞白血病（CLL）患者中比较固定疗程的 Sonrotoclax（也被称为 BGB-11417）联合泽布替尼（也被称为BGB-3111）（SZ）与固定疗程的维奈克拉联合阿可替尼（AV）的有效性和安全性。

试验分类	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	[["年龄≥ 18 岁，需根据2018 年iwCLL 标准确诊为CLL，且具有下列至少一项治疗指征：进行性骨髓衰竭；巨脾或进行性或有症状的脾肿大；巨块型淋巴结肿大或进行性或有症状的淋巴结肿大；倍增快速的进行性淋巴细胞增多症；症状性或功能性结外受累；和/或存在全身症状。"],["ECOG 体能状态评分为 0、1 或 2。"],["CT/MRI 显示有可测量病灶。"],["骨髓和器官功能良好。"],["有生育能力的女性患者必须愿意在研究期间和以下时间（以后发生者为准）采取高效避孕措施并且同意不得捐献卵子：n？ Sonrotoclax 末次给药后≥ 7 天，n？ 泽布替尼或维奈克拉末次给药后≥ 30 天，n？ 阿可替尼末次给药后≥ 7 天。n在入组和随机化前≤ 7 天，这些女性患者的血清妊娠试验结果必须为阴性，并且在第 1 周期第 1 天给药前 24 小时内的高灵敏度尿液或血清妊娠试验结果必须为阴性。"],["未绝育男性患者必须愿意在研究期间和以下时间（以后发生者为准）采取高效避孕措施并且不得捐献精子：n？ Sonrotoclax 末次给药后≥ 7 天，n？ 泽布替尼或维奈克拉末次给药后≥ 30 天，n？ 阿可替尼末次给药后≥ 7 天。"],["其他方案定义的入选标准也可能适用。"]]
排除标准	[["既往接受过 CLL 系统治疗。"],["已知患有幼淋巴细胞白血病、已知Richter 转化病史或目前怀疑发生Richter 转化 （临床怀疑转化的患者可能需进行活检来排除转化）。"],["有中枢神经系统（CNS）受累。"],["有经确认的进行性多灶性脑白质病（PML）病史的患者。"],["控制不良的高血压和有临床意义的心血管疾病。"],["重度或衰竭性肺部疾病，定义为：需长期补氧和/或需要辅助通气的呼吸衰竭。"],["需要治疗的控制不良的自身免疫性溶血性贫血或免疫性血小板减少症。"],["有既往恶性肿瘤病史，但以下情况除外（前提是患者已从既往治疗引起的急性副作用中恢复）：na. 接受根治性手术治疗且在入组和随机化前≥ 3 年无已知活动性疾病的恶性肿瘤。nb. 经充分治疗的非黑色素瘤皮肤癌或恶性雀斑样痣，目前无疾病证据。nc. 经充分治疗的宫颈原位癌，目前无疾病证据。nd. Gleason 评分≤ 6 的局限性前列腺癌。"],["筛选前 4 周内使用过试验用药物。"],["存在需要全身治疗的活动性真菌、细菌和/或病毒感染。"],["已知对泽布替尼、Sonrotoclax、阿可替尼、维奈克拉或其任何辅料（如海藻糖）、黄嘌呤氧化酶抑制剂或拉布立海有超敏反应或超敏反应史。"],["有严重出血性疾病史，如血友病 A、血友病 B、血管性血友病，或需要输血或其他医疗干预的自发性出血史。"],["妊娠期或哺乳期女性患者。"],["在入组和随机化前 28 天内接种活疫苗。"],["其他方案定义的排除标准也可能适用。"]]

试验药	[["中文通用名:索托克拉 英文通用名:Sonrotoclax 商品名称:百悦达","剂型:NA 规格:NA 用法用量:NA 用药时程:NA"],["中文通用名:泽布替尼 英文通用名:Zanubrutinib 商品名称:百悦泽","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:维奈克拉 英文通用名:Venetoclax 商品名称:唯可来","剂型:片剂 规格:10、50、100mg/片 用法用量:每日一次口服给药剂量（根据维奈克拉当地处方说明书给药） 用药时程:14个周期"],["中文通用名:阿可替尼 英文通用名:Acalabrutinib 商品名称:康可期","剂型:片剂 规格:100mg/片 用法用量:100mg，每日两次，持续14个周期 用药时程:14个周期"]] 序号 名称 用法

主要终点指标及评价时间

[["独立审查委员会（IRC）评估确定的无进展生存期(PFS)","大约70个月","有效性指标"],["灵敏度为< 10-4（uMRD4）时未能检测到MRD 的比率","大约16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

[["IRC 评估确定的高风险患者的 PFS、总缓解率（ORR）","大约70个月","有效性指标"],["总生存期 （OS）","大约70个月","有效性指标"],["研究者评估结果确定的 PFS、总缓解率（ORR）","大约70个月","有效性指标"],["灵敏度为< 10-5（uMRD5）时未能检测到MRD 的比率","大约16个月","有效性指标"],["发生不良事件（AE）、临床关注的不良事件（AECI）、严重不良事件（SAE）的患者数量","大约70个月","安全性指标"],["IRC 和研究者评估确定的总体 CRR、缓解持续 n时间（DOR）","大约70个月","有效性指标"],["至下一线治疗的时间（TTNT）","大约70个月","有效性指标"],["使用欧洲癌症研究与治疗组织（EORTC） n生活质量问卷（EORTC IL-409）较基线的变化","在基线和大约70个月","有效性指标+安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	李建勇	学位	医学博士	职称	主任医师
	电话	13951877733	Email	lijianyonglm@126.com	邮政地址	江苏省-南京市-广州路300
	邮编	210029	单位名称	南京医科大学第一附属医院（江苏省人民医院）

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KATER","Netherlands","ALMERE","ALMERE"],["CENTRE HOSPITALIER LE MANS","KAMEL LARIBI","France","Le Mans","Le Mans"],["CENTRE DE LUTTE CONTRE LE CANCER - INSTITUT BERGONIE","FONTANET BIJOU","France","BORDEAUX","BORDEAUX"],["CHU MONTPELLIER - HOPITAL SAINT ELOI","EMMANUELLE TCHERNONOG","France","MONTPELLIER","MONTPELLIER"],["CENTRE LEON BERARD","ANNE-SOPHIE MICHALLET","France","Lyon Cedex 8","Lyon Cedex 8"],["IUC TOULOUSE ONCOPOLE","LOIC YSEBAERT","France","Toulouse","Toulouse"],["CHU CLERMONT FERRAND - THERAPIE CELLULAIRE AND HEMATOLO","ROMAIN GUIEZE","France","CLERMONT-FERRAND","CLERMONT-FERRAND"],["HOPITAL CLAUDE HURIEZ - CHU LILLE","MORGANE NUDEL","France","Lille","Lille"],["HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA","JOSE ANTONIO GARCIA VELA","Spain","Majadahonda","Majadahonda"],["HOSPITAL UNIVERSITARIO 12 DE OCTUBRE","JAVIER DE LA SERNA","Spain","Madrid","Madrid"],["HOSPITAL CLINICO UNIVERSITARIO VIRGEN DE LA ARRIXACA","RAUL PEREZ LOPEZ","Spain","Murcia","Murcia"],["HOSPITAL UNIVERSITARIO VIRGEN DE LAS NIEVES","JOSE MANUEL PUERTA PUERTA","Spain","Granada","Granada"],["OSPEDALE SAN RAFFAELE","LYDIA SCARFO","Italy","Milano","Milano"],["AZIENDA SOCIO SANITARIA TERRITORIALE GRANDE OSPEDALE METROPOLITANO NIGUARDA","ANNA MARIA FRUSTACI","Italy","Milano","Milano"],["FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI","LUCA LAURENTI","Italy","Roma","Roma"],["AZIENDA OSPEDALIERA DI PADOVA","ANDREA VISENTIN","Italy","Padova","Padova"],["IRCCS AZIENDA OSPEDALIERO UNIVERSITARIA BOLOGNA","PIER LUIGI ZINZANI","Italy","Bologna","Bologna"],["AOU CAREGGI, SERVIZIO SANITARIO TOSCANA","ALESSANDRO SANNA","Italy","Firenze","Firenze"],["INSTITUTUL ONCOLOGIC","CIPRIAN TOMULEASA","Romania","Cluj-Napoca","Cluj-Napoca"],["COLTEA CLINICAL HOSPITAL","ANDREI COLITA","Romania","Bucharest","Bucharest"],["INSTITUTUL CLINIC FUNDENI","DANIEL CORIU","Romania","Bucuresti","Bucuresti"],["OXFORD UNIVERSITY HOSPITALS NHS TRUST - CHURCHILL HOSPITAL","TOBY EYRE","United Kingdom","Headington","Headington"],["ST JAMES'S UNIVERSITY HOSPITAL","TALHA MUNIR","United Kingdom","Leeds","Leeds"],["UNIVERSITY HOSPITALS DORSET - ROYAL BOURNEMOUTH HOSPITAL","RENATA WALEWSKA","United Kingdom","Bournemouth","Bournemouth"],["QUEEN ELIZABETH HOSPITAL","HELEN PARRY","United Kingdom","Birmingham","Birmingham"],["KING'S COLLEGE HOSPITAL","PIERS PATTEN","United Kingdom","London","London"],["KAROLINSKA UNIVERSITETSSJUKHUSET - SOLNA","ANDERS OSTERBORG","Sweden","Stockholm","Stockholm"],["PRATIA MCM KRAKOW","WOJCIECH JURCZAK","Poland","Krakow","Krakow"],["SZPITAL SPECJALIST. W BRZOZOWIE,PODKARPACKI OSRODEK ONKOLOGICZNY","JACEK KRZANOWSKI","Poland","Brzozow","Brzozow"],["PRATIA ONKOLOGIA KATOWICE","SEBASTIAN GROSICKI","Poland","KATOWICE","KATOWICE"],["UNIWERSYTECKI SZPITAL KLINICZNY NR 4 W LUBLINIE","KRZYSZTOF GIANNOPOULOS","Poland","LUBLIN","LUBLIN"],["UNIWERSYTECKI SZPITAL KLINICZNY IM. JANA MIKULICZA-RADECKIEGO WE WROCLAWIU","TOMASZ WROBEL","Poland","Wroclaw","Wroclaw"],["POMORSKI UNIWERSYTET MEDYCZNY W SZCZECINIE","BOGUSLAW MACHALINSKI","Poland","Szczecin","Szczecin"],["CENTRUM FUR HAEMATOLOGIE UND ONKOLOGIE BETHANIEN","CHRISTIAN SCHMITT","Germany","Frankfurt am Main","Frankfurt am Main"],["INVO - INSTITUT FUR VERSORGUNGSFORSCHUNG IN DER ONKOLOGIE","GEOTHY CHAKUPURAKAL","Germany","Koblenz","Koblenz"],["KLINIKUM OSNABRUECK GMBH - MEDIZINISCHEN VERSORGUNGSZENTRUM (MVZ)","PETRA MUNDMANN","Germany","Osnabruck","Osnabruck"],["KLINIKUM ST. ELISABETH STRAUBING GMBH - MEDIZINISCHE VERSORGUNGSZENTRUM (MVZ) KLINIKUM STRAUBING GMB","JOCHEN GRASSINGER","Germany","Straubing","Straubing"],["DONAUISAR KLINIKUM DEGGENDORF - KLINIK FüR ONKOLOGIE UND HAMATOLOGIE","MARKUS RADSAK","Germany","Deggendorf","Deggendorf"],["GEHO MUNSTER","RUDIGER LIERSCH","Germany","Munster","Munster"],["INSTITUTO D’OR DE PESQUISA E ENSINO - SAO PAULO","ABEL DA COSTA NETO","Brazil","Sao Paulo","Sao Paulo"],["SOCIEDADE BENEFICENTE ISRAELITA BRASILEIRA HOSPITAL ALBERT EINSTEIN","GUILHERME PERINI","Brazil","Sao Paulo","Sao Paulo"],["CENTRO GAUCHO INTEGRADO DE ONCOLOGIA – HOSPITAL MAE DE DEUS","MARCELO CAPRA","Brazil","Porto Alegre","Porto Alegre"],["INSTITUTO D’OR DE PESQUISA E ENSINO -DISTRITO FEDERAL","FLAVIA XAVIER","Brazil","Brasília","Brasília"],["ENSINO E TERAPIA DE INOVACAO CLINICA AMO-ETICA","MARIANNA LIMA","Brazil","Salvador","Salvador"],["AUSTIN HEALTH","DENISE LEE","Australia","Victoria","Heidelberg"],["CABRINI HOSPITAL MALVERN","MELITA KENEALY","Australia","Victoria","MALVERN EAST"],["CONCORD REPATRIATION GENERAL HOSPITAL","EMMA VERNER","Australia","New South Wales","Concord"],["MONASH HEALTH","STEPHEN OPAT","Australia","Victoria","Clayton"],["PRINCESS ALEXANDRA HOSPITAL","SASANKA HANDUNNETTI","Australia","Queensland","Woolloongabba"],["THE ALFRED HOSPITAL","CONSTANTINE TAM","Australia","Victoria","Melbourne"],["BLACKTOWN CANCER AND HAEMATOLOGY CENTRE","JULIANNE FALCONER","Australia","New South Wales","BLACKTOWN"],["GENESISCARE NORTH SHORE","DAVID KLIMAN","Australia","New South Wales","ST LEONARDS"],["NORTH SHORE HOSPITAL","ANNA ELINDER-CAMBURN","New Zealand","Auckland","Auckland"],["WELLINGTON REGIONAL HOSPITAL (CCDHB)","ROBERT WEINKOVE","New Zealand","Wellington","Wellington"],["AUCKLAND CITY HOSPITAL","HENRY NGU","New Zealand","Auckland","Auckland"],["HEALTH NEW ZEALAND – CANTERBURY","BLAKE HSU","New Zealand","Christchurch","Christchurch"],["DUNEDIN HOSPITAL","ANNA BYRNE","New Zealand","Central Dunedin","Central Dunedin"],["SEVERANCE HOSPITAL YONSEI UNIVERSITY HEALTH SYSTEM","JIN SEOK KIM","Korea","Seoul Teugbyeolsi","Seoul"],["SEOUL NATIONAL UNIVERSITY HOSPITAL","JA MIN BYUN","Korea","Seoul Teugbyeolsi","Seoul"],["THE CATHOLIC UNIVERSITY OF KOREA, SEOUL ST. MARY'S HOSPITAL","KI SEONG EOM","Korea","Seoul Teugbyeolsi","Seocho-Gu"],["SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL","JEONG-OK LEE","Korea","Gyeonggi-do","Seongnam-si"],["ASAN MEDICAL CENTER","JUNG-HEE LEE","Korea","Seoul Teugbyeolsi","Songpa-Gu"],["FAKULTNI NEMOCNICE OSTRAVA","JANA MIHALYOVA","Czech Republic","OSTRAVA","OSTRAVA"],["FAKULTNI NEMOCNICE HRADEC KRALOVE","MARTIN SIMKOVIC","Czech Republic","Hradec Kralove","Hradec Kralove"],["VSEOBECNA FAKULTNI NEMOCNICE V PRAZE","MARTIN SPACEK","Czech Republic","Praha","Praha"],["FAKULTNI NEMOCNICE BRNO","MICHAEL DOUBEK","Czech Republic","Brno","Brno"],["FAKULTNI NEMOCNICE OLOMOUC","ZUZANA KUBOVA","Czech Republic","Olomouc","Olomouc"],["FAKULTNI NEMOCNICE PLZEN","DANIEL LYSAK","Czech Republic","PLZEN","PLZEN"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["南京医科大学第一附属医院伦理委员会","同意","2025-11-26"],["南京医科大学第一附属医院伦理委员会","同意","2026-01-09"],["上海交通大学医学院附属瑞金医院临床试验伦理委员会","同意","2026-02-04"]]

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: 75 ； 国际: 500 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
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：2026-01-22；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
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；