一项研究 Sonrotoclax 加 Zanubrutinib 与安慰剂加 Zanubrutinib 治疗成人复发/难治性套细胞淋巴瘤的疗效和安全性的研究
Sonrotoclax 加 Zanubrutinib 与安慰剂加 Zanubrutinib 治疗复发/难治性套细胞淋巴瘤患者的 3 期随机双盲多中心研究
The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.
研究概览
详细说明
Mantle cell lymphoma (MCL) is a rare, aggressive type of B-cell lymphoma. B-cells are white blood cells that help fight infections. Lymphoma is a cancer in the lymphatic system. Sometimes this type of cancer can come back after treatment (relapse), or it does not respond to treatment or stops responding to treatment (refractory).
Sonrotoclax is a drug which blocks a protein called B-cell lymphoma-2 (Bcl-2). Zanubrutinib works by blocking a protein called Bruton tyrosine kinase (BTK). Bcl-2 and BTK help certain blood cancer cells live and grow. By blocking Bcl-2 and BTK, sonrotoclax and zanubrutinib may slow or stop cancer cell growth and help them die.
The purpose of this study is to test if sonrotoclax plus zanubrutinib is safe and if it works better in adults with R/R MCL compared to zanubrutinib plus placebo. The main goal is to compare how long participants live without their disease getting worse. The study will also evaluate side effects and overall safety.
This study has two treatment groups. Participants will be randomly assigned (by chance) to receive sonrotoclax plus zanubrutinib or zanubrutinib plus placebo. All study treatments will be taken by mouth. Placebo is a pill that looks like the study drug but has no active ingredient. Participants and the study doctor will not know what treatment group the participant is assigned to during the study, unless there is an urgent medical need.
The study will enroll approximately 300 adults with R/R MCL at multiple centers worldwide.
The overall time to participate in this study is up to approximately 7 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor imaging tests.
Note: Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Study Director
- 电话号码：1.877.828.5568
- 邮箱：clinicaltrials@beonemed.com
学习地点
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100142
- 招聘中
- Beijing Cancer Hospital
-
-
Chongqing Municipality
-
Chongqing、Chongqing Municipality、中国、630014
- 招聘中
- The First Affiliated Hospital of Chongqing Medical University
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510515
- 招聘中
- Nanfang Hospital, Southern Medical University
-
Guangzhou、Guangdong、中国、510060
- 招聘中
- Sun Yat Sen University Cancer Center
-
-
Heilongjiang
-
Harbin、Heilongjiang、中国、150000
- 招聘中
- Harbin Medical University Cancer Hospital
-
-
Henan
-
Zhengzhou、Henan、中国、450052
- 招聘中
- The First Affiliated Hospital of Zhengzhou University
-
-
Hubei
-
Wuhan、Hubei、中国、430030
- 主动，不招人
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
-
Wuhan、Hubei、中国、430022
- 主动，不招人
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210029
- 招聘中
- Jiangsu Province Hospital
-
Xuzhou、Jiangsu、中国、221000
- 招聘中
- The Affiliated Hospital of Xuzhou Medical University
-
-
Jiangxi
-
Nanchang、Jiangxi、中国、330029
- 招聘中
- Jiangxi Cancer Hospital
-
-
Liaoning
-
Shenyang、Liaoning、中国、110042
- 招聘中
- Liaoning Cancer Hospital and Institute
-
-
Shaanxi
-
Xi'an、Shaanxi、中国、710068
- 招聘中
- Shaanxi Provincial Peoples Hospital
-
-
Shandong
-
Linyi、Shandong、中国、276001
- 招聘中
- Linyi Cancer Hospital
-
Qingdao、Shandong、中国、266555
- 招聘中
- The Affiliated Hospital of Qingdao University Branch West Coast
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200000
- 招聘中
- Fudan University Shanghai Cancer Center
-
-
Sichuan
-
Chengdu、Sichuan、中国、610071
- 招聘中
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310002
- 招聘中
- The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
-
Wenzhou、Zhejiang、中国、325000
- 招聘中
- The First Affiliated Hospital of Wenzhou Medical University
-
-
-
-
-
Ankara、土耳其（türkiye）、06170
- 主动，不招人
- Etlik City Hospital
-
Dokuma、土耳其（türkiye）、07025
- 主动，不招人
- Antalya Memorial Hospital
-
Kocaeli、土耳其（türkiye）、41380
- 主动，不招人
- Kocaeli Universitesi Tip Fakultesi
-
-
-
-
-
Sankt Pölten、奥地利、3100
- 主动，不招人
- Uk St Poelten
-
-
-
-
-
Barretos、巴西、14.784-400
- 主动，不招人
- Fundacao Pio Xii Hospital de Amor de Barretos
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Belo Horizonte、巴西、30110-068
- 主动，不招人
- Hospital Felicio Rocho
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Campinas、巴西、13083-878
- 主动，不招人
- Universidade de Campinas Centro de Hematologia E Hemoterapia
-
Caxias do Sul、巴西、95070-560
- 主动，不招人
- Fundacao Universidade de Caxias Do Sul
-
Curitiba、巴西、81520-060
- 主动，不招人
- Hospital Erasto Gaertner
-
Joinville、巴西、89201-260
- 主动，不招人
- Instituto Joinvilense de Hematologia E Oncologia
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Porto AlegreRS、巴西、900350-903
- 主动，不招人
- Hospital de Clinicas de Porto Alegre
-
Recife、巴西、50040-000
- 主动，不招人
- Hospital Do Cancer de Pernambuco
-
São Paulo、巴西、05403-010
- 主动，不招人
- Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
-
Vitória、巴西、29043-260
- 招聘中
- Hospital Santa Rita de Cassia Afecc
-
-
-
-
-
Chemnitz、德国、09116
- 招聘中
- Klinikum Chemnitz Ggmbh
-
Frankfurt am Main、德国、60596
- 招聘中
- Universitatsklinikum Frankfurt
-
Halle、德国、06120
- 招聘中
- Universitatsklinikum Halle
-
Mutlangen、德国、73557
- 招聘中
- Stauferklinikum Schwabisch Gmund Kliniken Ostalb
-
München、德国、81377
- 招聘中
- Dept of Medicine Iii, University Hospitallmu
-
Siegen、德国、57074
- 招聘中
- Diakonie Klinikum Jung Stilling Krankenhaus
-
Stuttgart、德国、70376
- 招聘中
- Robert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und Palliativmedizin
-
-
-
-
-
Bologna、意大利、40138
- 主动，不招人
- Policlinico Sorsola Malpighi, Aou Di Bologna
-
Lecce、意大利、73100
- 主动，不招人
- Ospedale Vito Fazzi, Asl Lecce
-
Meldola、意大利、47014
- 主动，不招人
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
-
Trieste、意大利、34129
- 主动，不招人
- Azienda Sanitaria Universitaria Giuliano Isontina
-
Verona、意大利、37134
- 主动，不招人
- Centroricerche Cliniche Di Verona Srl
-
-
-
-
-
Auckland、新西兰、0622
- 主动，不招人
- North Shore Hospital
-
Christchurch、新西兰、8011
- 主动，不招人
- Christchurch Hospital
-
Dunedin、新西兰、9016
- 主动，不招人
- Dunedin Hospital
-
Tauranga、新西兰、3112
- 主动，不招人
- Tauranga Hospital
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Wellington、新西兰、6021
- 主动，不招人
- Wellington Regional Hospital (Ccdhb)
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-
-
-
-
Yokohama、日本、221-0855
- 招聘中
- Yokohama Municipal Citizens Hospital
-
-
Aichi-ken
-
Nagoya、Aichi-ken、日本、464-8681
- 招聘中
- Aichi Cancer Center Hospital Clinical Oncology
-
Toyohashishi、Aichi-ken、日本、441-8570
- 招聘中
- Toyohashi Municipal Hospital
-
-
Chiba
-
Chiba、Chiba、日本、260-8717
- 招聘中
- Chiba Cancer Center
-
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Ehime
-
Matsuyama、Ehime、日本、790 8524
- 招聘中
- Matsuyama Red Cross Hospital
-
-
Gifu
-
Ōgaki、Gifu、日本、503-8502
- 招聘中
- Ogaki Municipal Hospital
-
-
Hiroshima
-
Hiroshima、Hiroshima、日本、730-8619
- 招聘中
- Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
-
-
Hokkaido
-
Sapporo、Hokkaido、日本、060-8648
- 招聘中
- Hokkaido University Hospital
-
-
Hyōgo
-
KobeShi、Hyōgo、日本、650-0047
- 招聘中
- Kobe City Medical Center General Hospital
-
-
Kagoshima-ken
-
Kagoshima、Kagoshima-ken、日本、890-8520
- 招聘中
- Kagoshima University Hospital
-
-
Kanagawa
-
Yokohama、Kanagawa、日本、241-8515
- 招聘中
- Kanagawa Cancer Center
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-
Miyagi
-
Sendai、Miyagi、日本、980-8574
- 招聘中
- Tohoku University Hospital
-
-
Okayama-ken
-
Kurashikishi、Okayama-ken、日本、710-8602
- 招聘中
- Kurashiki Central Hospital
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Okayama、Okayama-ken、日本、701-1192
- 招聘中
- National Hospital Organization Okayama Medical Center
-
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Osaka
-
Osaka、Osaka、日本、545-8586
- 招聘中
- Osaka Metropolitan University Hospital
-
Osakashi、Osaka、日本、543-8555
- 招聘中
- Osaka Red Cross Hospital
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-
Saitama
-
Koshigaya、Saitama、日本、503-8502
- 招聘中
- Dokkyo Medical University Saitama Medical Center
-
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Tokyo
-
Bunkyoku、Tokyo、日本、113-8519
- 招聘中
- Institute of Science Tokyo Hospital
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-
-
-
-
Montpellier、法国、34090
- 招聘中
- Chu Montpellier Hopital Saint Eloi
-
Nantes、法国、44000
- 主动，不招人
- Centre Hospitalier Universitaire Nantes Hotel Dieu
-
PierreBenite、法国、69495
- 主动，不招人
- Chu Hopital Lyon Sud
-
Tours、法国、37000
- 招聘中
- Chu Tours Hopital Bretonneau
-
-
-
-
-
Krakow、波兰、30-727
- 主动，不招人
- Pratia McM Krakow
-
Lodz、波兰、93-510
- 主动，不招人
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
-
Lublin、波兰、20-090
- 主动，不招人
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
-
Skorzewo、波兰、60-185
- 主动，不招人
- Aidport Sp Z O O
-
Wroclaw、波兰、53-439
- 主动，不招人
- Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii
-
-
-
-
-
San Juan、波多黎各、00917
- 招聘中
- Auxilio Mutuo Cancer Center
-
-
-
-
Queensland
-
Birtinya、Queensland、澳大利亚、QLD 4575
- 主动，不招人
- Sunshine Coast Hospital and Health Service
-
-
Victoria
-
Box Hill、Victoria、澳大利亚、VIC 3128
- 主动，不招人
- Box Hill Hospital
-
Clayton、Victoria、澳大利亚、VIC 3168
- 主动，不招人
- Monash Health
-
-
Western Australia
-
Cooloongup、Western Australia、澳大利亚、WA 6168
- 主动，不招人
- Rockingham Hospital
-
West Perth、Western Australia、澳大利亚、WA 6005
- 主动，不招人
- Perth Blood Institute
-
-
-
-
Alabama
-
Birmingham、Alabama、美国、35294-0004
- 招聘中
- University of Alabama At Birmingham Hospital
-
-
Arizona
-
Tucson、Arizona、美国、85724-0001
- 招聘中
- University of Arizona Cancer Center
-
-
California
-
Fresno、California、美国、93701
- 招聘中
- Ucsf Fresno
-
Irvine、California、美国、92618-3734
- 招聘中
- Kaiser Permanente Southern California
-
-
Connecticut
-
New Haven、Connecticut、美国、06520-8028
- 招聘中
- Yale University Yale Cancer Center
-
-
Florida
-
Pembroke Pines、Florida、美国、33026-4119
- 招聘中
- Memorial Cancer Institute, Memorial Healthcare System
-
Weston、Florida、美国、33331-3609
- 招聘中
- Cleveland Clinic Florida
-
-
Illinois
-
Chicago、Illinois、美国、60607
- 招聘中
- Rush University Medical Center
-
Chicago、Illinois、美国、60637-1443
- 招聘中
- University of Chicago Medical Center
-
-
Indiana
-
Fort Wayne、Indiana、美国、46804
- 招聘中
- Fort Wayne Medical Oncology and Hematology
-
-
Iowa
-
Waukee、Iowa、美国、50263
- 招聘中
- Mission Cancer and Blood
-
-
Louisiana
-
Baton Rouge、Louisiana、美国、70808-4365
- 招聘中
- Our Lady of the Lake Hospital
-
-
Maryland
-
Baltimore、Maryland、美国、21201
- 招聘中
- The University of Maryland Greenebaum Comprehensive Cancer Center
-
-
Massachusetts
-
Boston、Massachusetts、美国、02215-5418
- 招聘中
- Dana Farber Cancer Institute Longwood Medical Center
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109-1382
- 招聘中
- University of Michigan
-
Grand Rapids、Michigan、美国、49503-2563
- 招聘中
- The Cancer and Hematology Centers
-
-
Minnesota
-
Rochester、Minnesota、美国、55905-0001
- 招聘中
- Mayo Clinic Rochester
-
-
Mississippi
-
Hattiesburg、Mississippi、美国、39401-7233
- 招聘中
- Hattiesburg Hematology and Oncology Clinic
-
-
Missouri
-
St Louis、Missouri、美国、63110-1010
- 招聘中
- Washington University School of Medicine
-
-
Nebraska
-
Grand Island、Nebraska、美国、68803
- 招聘中
- Nebraska Cancer Specialists St Francis Grand Island
-
Omaha、Nebraska、美国、68130-2042
- 招聘中
- Nebraska Cancer Specialists
-
-
New Jersey
-
Paramus、New Jersey、美国、07652
- 招聘中
- The Valley Hospital, Inc
-
-
New York
-
New York、New York、美国、10065-6800
- 招聘中
- Memorial Sloan Kettering Cancer Center Mskcc
-
-
North Carolina
-
Charlotte、North Carolina、美国、28204-2990
- 招聘中
- Atrium Health Levine Cancer Institute (Lci)
-
Durham、North Carolina、美国、27710
- 招聘中
- Duke University
-
Winston-Salem、North Carolina、美国、27157
- 招聘中
- Atrium Health Wake Forest Baptist
-
-
Ohio
-
Cleveland、Ohio、美国、44195-0001
- 招聘中
- Cleveland Clinic Foundation
-
Cleveland、Ohio、美国、44106-1716
- 招聘中
- University Hospitals
-
Columbus、Ohio、美国、43210-1280
- 招聘中
- Ohio State University Comprehensive Cancer Center
-
Columbus、Ohio、美国、43214-3907
- 招聘中
- Ohio Health Research Institute
-
-
Pennsylvania
-
Hershey、Pennsylvania、美国、17033
- 招聘中
- Penn State Milton S Hershey Medical Center
-
West Reading、Pennsylvania、美国、19611-2143
- 招聘中
- McGlinn Cancer Institute
-
-
Tennessee
-
Nashville、Tennessee、美国、37205
- 招聘中
- Tennessee Oncology
-
Nashville、Tennessee、美国、37205
- 招聘中
- Tennessee Oncology Nashville St Thomas Midtown Clinic
-
-
Texas
-
Houston、Texas、美国、77030-3907
- 招聘中
- Md Anderson Cancer Center
-
Round Rock、Texas、美国、78681-4019
- 招聘中
- Texas Oncology Austin Midtown
-
-
Virginia
-
Charlottesville、Virginia、美国、22908-0817
- 招聘中
- University of Virginia
-
Gainesville、Virginia、美国、20155-3257
- 招聘中
- Virgina Cancer Specialists
-
Richmond、Virginia、美国、23298-5026
- 招聘中
- Vcu Massey Cancer Center
-
-
Washington
-
Vancouver、Washington、美国、98684-6930
- 招聘中
- Northwest Cancer Specialist, Pc(Us Oncology Research)
-
-
Wisconsin
-
Madison、Wisconsin、美国、53792-0001
- 招聘中
- University of Wisconsin
-
-
-
-
-
Birmingham、英国、B9 5SS
- 招聘中
- Birmingham Heartlands Hospital
-
Bournemouth、英国、BH7 7DW
- 招聘中
- The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
-
Glasgow、英国、G12 0YN
- 招聘中
- Beatson West of Scotland Cancer Centre
-
Headington、英国、OX3 7LE
- 招聘中
- Oxford University Hospitals Nhs Trust Churchill Hospital
-
London、英国、NW1 2PG
- 招聘中
- University College Hospital
-
Metropolitan Borough of Wirral、英国、CH63 4JY
- 招聘中
- Clatterbridge Cancer Centre
-
Plymouth、英国、PL6 8DH
- 招聘中
- Derriford Hospital
-
-
-
-
-
Barcelona、西班牙、08036
- 主动，不招人
- Hospital Clinic de Barcelona
-
Barcelona、西班牙、08907
- 主动，不招人
- Ico H Duran I Reynals
-
Madrid、西班牙、28040
- 完全的
- Hospital Universitario Fundacion Jimenez Diaz
-
Majadahonda、西班牙、28222
- 主动，不招人
- H Puerta de Hierro Majadahonda
-
-
-
-
-
Caba、阿根廷、CP1114
- 主动，不招人
- FUNDALEU
-
Caba、阿根廷、1425
- 招聘中
- Hospital Aleman
-
Ciudad Autonoma Buenos Aires、阿根廷、1413
- 主动，不招人
- Hospital Italiano de Buenos Aires
-
Córdoba、阿根廷、X5000HUA
- 主动，不招人
- Hospital Universitario de Cordoba
-
-
-
-
Busan Gwang'Yeogsi
-
Seogu、Busan Gwang'Yeogsi、韩国、49241
- 主动，不招人
- Pusan National University Hospital
-
-
Seoul Teugbyeolsi
-
GangnamGu、Seoul Teugbyeolsi、韩国、06351
- 主动，不招人
- Samsung Medical Center
-
SeochoGu、Seoul Teugbyeolsi、韩国、06591
- 主动，不招人
- The Catholic University of Korea, Seoul St Marys Hospital
-
Seoul、Seoul Teugbyeolsi、韩国、03080
- 主动，不招人
- Seoul National University Hospital
-
SongpaGu、Seoul Teugbyeolsi、韩国、05505
- 主动，不招人
- Asan Medical Center
-
Yeongdeungpo-gu、Seoul Teugbyeolsi、韩国、07345
- 主动，不招人
- The Catholic University of Korea, Yeouido St Marys Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
- Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis
- Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
- Relapsed or refractory disease after the last line of therapy
- Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Adequate organ function
Exclusion Criteria:
- Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
- Prior therapy with BTK degraders
- Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.
- Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
- Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
- Known central nervous system involvement by lymphoma
- Clinically significant cardiovascular disease
- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm A: sonrotoclax plus zanubrutinib
Sonrotoclax and zanubrutinib will be administered in combination. |
Administered orally
其他名称：
Administered orally
其他名称：
|
|
安慰剂比较：Arm B: placebo plus zanubrutinib
Placebo and zanubrutinib will be administered in combination. |
Administered orally Administered orally
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
大体时间：Approximately 41 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Approximately 41 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival (OS)
大体时间：Approximately 92 months
|
OS is defined as the time from randomization to the date of death from any cause. |
Approximately 92 months
|
|
PFS as assessed by investigator (INV)
大体时间：Approximately 58 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Approximately 58 months
|
|
Overall Response Rate (ORR) as assessed by BIRC and by INV
大体时间：Approximately 58 months
|
ORR is defined as the percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR), per Lugano 2014 criteria. |
Approximately 58 months
|
|
Duration of Response (DOR) as assessed by BIRC and by INV
大体时间：Approximately 58 months
|
DOR is defined as the time from the first qualifying response to the date of progression or death, whichever occurs first. |
Approximately 58 months
|
|
Complete Response Rate (CRR) as assessed by BIRC and by INV
大体时间：Approximately 58 months
|
CRR is defined as the percentage of participants who achieved a best overall response of CR. |
Approximately 58 months
|
|
Time to first response as assessed by BIRC and by INV
大体时间：Approximately 58 months
|
Time to first response is defined as time from the date of randomization to first response. |
Approximately 58 months
|
|
Time to initiation of new anticancer therapy
大体时间：Approximately 58 months
|
Time to initiation of new anticancer therapy is defined as time from the date of randomization to the date of initiation of new anticancer therapy. |
Approximately 58 months
|
|
Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Non-Hodgkin Lymphoma High Grade Module 29 (EORTC-QLQ-NHL-HG29)
大体时间：Approximately 58 months
|
Patient-reported symptom burden, neuropathy, and physical condition/fatigue as measured by the EORTC-QLQ-NHL-HG29 questionnaire. The EORTC-QLQ-NHL-HG29 is the NHL-aggressive module of QLQ-C30; and it consists of 5 scales: Symptom burden due to disease and/or treatment (7 items), Neuropathy (2 items), Physical condition/Fatigue (5 items), Emotional impacts (4 items), and Worries/Fears health and functioning (11 items). Items are rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much"). A higher score for all the multi-item scales and items represents a higher level of symptomatology or problems. |
Approximately 58 months
|
|
Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
大体时间：Approximately 58 months
|
Patient-reported global health status (GHS), role, and physical function as measured by the EORTC-QLQ-C30 questionnaire. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best). |
Approximately 58 months
|
|
Number of participants with treatment-emergent adverse events (TEAEs)
大体时间：From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months
|
Number of participants with TEAEs, including laboratory values, vital signs, electrocardiogram results, and physical examination findings, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. |
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months
|
合作者和调查者
调查人员
- 研究主任：Study Director、BeOne Medicines
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- BGB-11417-302
- 2024-515593-27-00 (克蒂斯)
- CTR20250207 (注册表标识符：ChinaDrugTrials)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
IPD 共享时间框架
See plan description
IPD 共享访问标准
See plan description
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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