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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524366-21-00 | EU Trial (CTIS) Number |
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The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Sonrotoclax plus Zanubrutinib | Experimental | Participants will receive sonrotoclax and zanubrutinib for a fixed duration followed by observation. |
|
| Arm B: Venetoclax plus Acalabrutinib | Active Comparator | Participants will receive venetoclax and acalabrutinib for a fixed duration followed by observation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonrotoclax | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC) | PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first. | Up to approximately 70 months |
| Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4) | Rate of uMRD4 is defined as the percentage of participants that achieved uMRD4 measured in both peripheral blood (PB) and bone marrow aspirate (BMA) at the post-treatment follow-up visit (PTFU1) based on next generation sequencing (NGS). | Up to approximately 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS in High-Risk Participants | PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first. | Up to approximately 70 months |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 8778285568 | clinicaltrials@beonemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeOne Medicines | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | Recruiting | Palo Alto | California | 94304-2205 | United States | |
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.
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See plan description
See plan description
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| Zanubrutinib | Drug | Administered orally. |
|
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| Acalabrutinib | Drug | Administered orally. |
|
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| Venetoclax | Drug | Administered orally. |
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OS is defined as the time from the date of randomization to the date of death due to any cause.
| Up to approximately 70 months |
| Overall Response Rate (ORR) as Determined by IRC | ORR is defined as the percentage of participants with a complete response (CR), complete response with incomplete hematopoietic recovery (CRi), nodal partial response (nPR), or partial response (PR), before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier), as assessed by IRC. | Up to approximately 70 months |
| Rate of Undetectable Minimal Residual Disease at < 10^-5 sensitivity (uMRD5) | Rate of uMRD5 is defined as the percentage of participants who achieved uMRD5 measured in both PB and BMA at the PTFU1 Visit based on NGS, before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier). | Up to approximately 16 months |
| Number of Participants with Adverse Events | Number of participants with treatment-emergent adverse events (TEAEs), adverse events of clinical interest, and serious adverse events (SAEs), including laboratory values, vital signs, and physical examination findings. | Up to approximately 70 months |
| PFS Determined by Investigator Assessment | PFS is defined as the time from the date of randomization to the date of disease progression as determined by investigator or death due to any cause, whichever occurs first. | Up to approximately 70 months |
| Complete Response Rate (CRR) by IRC and Investigator Assessment | CRR is defined as the percentage of participants with a CR or CRi before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier). | Up to approximately 70 months |
| ORR Determined by Investigator Assessment | ORR is defined as the percentage of participants with a complete response or partial response, before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier), as assessed by investigator. | Up to approximately 70 months |
| Duration of Response (DOR) | Duration of response (determined by both IRC and investigator assessment) is defined as the time from the first qualifying response (CR, CRi, nPR, or PR) until CLL progression or death. DOR analysis will only include responders. | Up to approximately 70 months |
| Time to Next Treatment (TTNT) | TTNT is defined as the time from randomization to the start of the next treatment for CLL. | Up to approximately 70 months |
| Change from Baseline in Score on European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL)-409 Questionnaire | Patient-reported symptoms of global health status (GHS), role functioning, and physical functioning, symptom burden and physical condition/fatigue will be measured using the European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC IL-409 (an itemized version of [EORTC] quality of life questionnaire core 30 [QLQ-C30] and its CLL module CLL17). The EORTC-IL-409 consists of 17 questions answered on a 4-point scale where 1 = Not at all (best) to 4 = Very Much (worst) and 2 global health questions answered on a 7-point scale where 1 = Very poor (worst) to 7 = Excellent (best). Higher scores in GHS and functional scales and lower scores in symptom scales indicate better quality of life. | At baseline and up to approximately 70 months |
| Fred Hutchinson Cancer Research Center |
| Recruiting |
| Seattle |
| Washington |
| 98109-4433 |
| United States |
| Blacktown Cancer and Haematology Centre | Recruiting | Blacktown | New South Wales | NSW 2148 | Australia |
| Concord Repatriation General Hospital | Recruiting | Concord | New South Wales | NSW 2139 | Australia |
| Genesiscare North Shore | Recruiting | St Leonards | New South Wales | NSW 2065 | Australia |
| Princess Alexandra Hospital | Recruiting | Woolloongabba | Queensland | QLD 4102 | Australia |
| Monash Health | Recruiting | Clayton | Victoria | VIC 3168 | Australia |
| Austin Health | Recruiting | Heidelberg | Victoria | VIC 3084 | Australia |
| Cabrini Hospital Malvern | Recruiting | Malvern | Victoria | VIC 3144 | Australia |
| The Alfred Hospital | Recruiting | Melbourne | Victoria | VIC 3004 | Australia |
| Instituto Dor de Pesquisa E Ensino Distrito Federal | Recruiting | Brasília | 70390140 | Brazil |
| Centro Gaucho Integrado de Oncologia Hospital Mae de Deus | Recruiting | Porto Alegre | 90110-270 | Brazil |
| Instituto Dor de Pesquisa E Ensino Sao Paulo | Recruiting | São Paulo | 01401-004 | Brazil |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | Recruiting | São Paulo | 05652-900 | Brazil |
| Bc Cancer Victoria | Recruiting | Victoria | British Columbia | V8R 6V5 | Canada |
| Juravinski Cancer Centre | Recruiting | Hamilton | Ontario | L8V 5C2 | Canada |
| Ciusss Nim Hscm | Recruiting | Montreal | Quebec | H4J 1C5 | Canada |
| Jewish General Hospital | Recruiting | Montreal | Quebec | QC H3t 1E2 | Canada |
| Ciusss de Lestrie Chus | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic) | Recruiting | Québec | G1J 1Z4 | Canada |
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 630014 | China |
| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350005 | China |
| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
| Sun Yat Sen University Cancer Center Huangpu Branch | Recruiting | Guangzhou | Guangdong | 510555 | China |
| The First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530021 | China |
| Guizhou Provincial Peoples Hospital | Recruiting | Guiyang | Guizhou | 550002 | China |
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150000 | China |
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410011 | China |
| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | 210029 | China |
| Affiliated Hospital of Nantong University | Recruiting | Nantong | Jiangsu | 201203 | China |
| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
| The Second Affiliated Hospital of Xian Jiaotong University | Recruiting | Xi'an | Shaanxi | 710004 | China |
| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | 250021 | China |
| Rui Jin Hospital Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital | Recruiting | Chengdu | Sichuan | 610071 | China |
| Institute of Hematology and Hospital of Blood Disease | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
| First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650032 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan | Recruiting | Hangzhou | Zhejiang | 310002 | China |
| Fakultni Nemocnice Brno | Recruiting | Brno | 625 00 | Czechia |
| Fakultni Nemocnice Hradec Kralove | Recruiting | Hradec Králové | 500 03 | Czechia |
| Fakultni Nemocnice Olomouc | Recruiting | Olomouc | 77900 | Czechia |
| Fakultni Nemocnice Ostrava | Recruiting | Ostrava | 708 00 | Czechia |
| Fakultni Nemocnice Plzen | Recruiting | PLZE | 323 00 | Czechia |
| Vseobecna Fakultni Nemocnice V Praze | Recruiting | Prague | 10000 | Czechia |
| Centre de Lutte Contre Le Cancer Institut Bergonie | Recruiting | Bordeaux | 33000 | France |
| Chu Clermont Ferrand Therapie Cellulaire and Hematolo | Recruiting | ClermontFerrand | 63100 | France |
| Centre Hospitalier Le Mans | Recruiting | Le Mans | 72037 | France |
| Hopital Claude Huriez Chu Lille | Recruiting | Lille | 59000 | France |
| Centre Leon Berard | Recruiting | Lyon | 69373 | France |
| Chu Montpellier Hopital Saint Eloi | Recruiting | Montpellier | 34090 | France |
| Iuc Toulouse Oncopole | Recruiting | Toulouse | 31100 | France |
| Donauisar Klinikum Deggendorf Klinik Fur Onkologie Und Hamatologie | Recruiting | Deggendorf | 94469 | Germany |
| Centrum Fur Haematologie Und Onkologie Bethanien | Recruiting | Frankfurt am Main | 60389 | Germany |
| Klinikum St Elisabeth Straubing Gmbh Mvz Klinikum Straubing Gmbh | Recruiting | Straubing | 94315 | Germany |
| Irccs Azienda Ospedaliero Universitaria Bologna | Recruiting | Bologna | 40138 | Italy |
| Aou Careggi, Servizio Sanitario Toscana | Recruiting | Florence | 50134 | Italy |
| Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
| Azienda Ospedaliera Di Padova | Recruiting | Padova | 35128 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli | Recruiting | Roma | 00168 | Italy |
| Flevoziekenhuis | Recruiting | Almere Stad | 1315 RA | Netherlands |
| Albert Schweitzer Ziekenhuis | Recruiting | Dordrecht | 3318 AT | Netherlands |
| North Shore Hospital | Recruiting | Auckland | 0622 | New Zealand |
| Auckland City Hospital | Recruiting | Auckland | 1023 | New Zealand |
| Health New Zealand Canterbury | Recruiting | Christchurch | 8011 | New Zealand |
| Dunedin Hospital | Recruiting | Dunedin | 9016 | New Zealand |
| Wellington Regional Hospital (Ccdhb) | Recruiting | Wellington | 6021 | New Zealand |
| Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny | Recruiting | Brzozów | 36-200 | Poland |
| Pratia Onkologia Katowice | Recruiting | Katowice | 40-519 | Poland |
| Pratia McM Krakow | Recruiting | Krakow | 30-727 | Poland |
| Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie | Recruiting | Lublin | 20-090 | Poland |
| Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu | Recruiting | Wroclaw | 50-367 | Poland |
| Coltea Clinical Hospital | Recruiting | Bucharest | 30171 | Romania |
| Institutul Clinic Fundeni | Recruiting | Bucureti | 022328 | Romania |
| Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca | Recruiting | ClujNapoca | 400015 | Romania |
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| The Catholic University of Korea, Seoul St Marys Hospital | Recruiting | SeochoGu | Seoul Teugbyeolsi | 06591 | South Korea |
| Severance Hospital Yonsei University Health System | Recruiting | SeodaemunGu | Seoul Teugbyeolsi | 03722 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Asan Medical Center | Recruiting | SongpaGu | Seoul Teugbyeolsi | 05505 | South Korea |
| Hospital Universitario Virgen de Las Nieves | Recruiting | Granada | 18014 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Recruiting | Majadahonda | 28222 | Spain |
| Hospital Clinico Universitario Virgen de La Arrixaca | Recruiting | Murcia | 30120 | Spain |
| Karolinska Universitetssjukhuset Solna | Recruiting | Stockholm | 171 76 | Sweden |
| University Hospitals Dorset Royal Bournemouth Hospital | Recruiting | Bournemouth | BH7 7DW | United Kingdom |
| Kings College Hospital | Recruiting | London | SE5 9RS | United Kingdom |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| C000604908 | acalabrutinib |
| C579720 | venetoclax |
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