A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma
- Conditions
- Mantle Cell LymphomaB Cell Lymphoma
- Interventions
- Registration Number
- NCT06742996
- Lead Sponsor
- BeiGene
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
- 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
- Prior therapy with B-cell lymphoma-2 inhibitor
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: sonrotoclax plus zanubrutinib Sonrotoclax Sonrotoclax and zanubrutinib will be administered in combination. Arm A: sonrotoclax plus zanubrutinib Zanubrutinib Sonrotoclax and zanubrutinib will be administered in combination. Arm B: placebo plus zanubrutinib Zanubrutinib Placebo and zanubrutinib will be administered in combination. Arm B: placebo plus zanubrutinib Placebo Placebo and zanubrutinib will be administered in combination.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) Approximately 49 months PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) as assessed by BIRC and by INV Approximately 66 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.
Overall Survival (OS) Approximately 92 months OS is defined as the time from randomization to the date of death from any cause.
PFS as assessed by investigator (INV) Approximately 66 months PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Duration of Response (DOR) as assessed by BIRC and by INV Approximately 66 months DOR is defined as the time from the first qualifying response to the date of progression or death, whichever occurs first.
Complete Response Rate (CRR) as assessed by BIRC and by INV Approximately 66 months CRR is defined as the percentage of participants who achieved a best overall response of CR.
Time to first response as assessed by BIRC and by INV Approximately 66 months Time to first response is defined as time from the date of randomization to first response.
Time to initiation of new anticancer therapy Approximately 66 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.
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) Approximately 66 months Patient-reported symptom burden 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.
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) Approximately 66 months Patient-reported physical condition/fatigue as measured by global health status (GHS) 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).
Number of participants with treatment-emergent adverse events (TEAEs) From the first dose of study drug(s) to 30 days after the last dose; up to approximately 66 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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (146)
Uniwersytecki Szpital Kliniczny Nr W Lublinie
🇵🇱Lublin, Poland
University of Alabama At Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
Mayo Clinic Phoenix
🇺🇸Phoenix, Arizona, United States
Yale University, Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Memorial Cancer Institute, Memorial Healthcare System
🇺🇸Pembroke Pines, Florida, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
Mission Cancer and Blood
🇺🇸Waukee, Iowa, United States
University of Maryland Greenebaum Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Dana Farber Cancer Institute Longwood Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
The Cancer and Hematology Centers
🇺🇸Grand Rapids, Michigan, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Hattiesburg Hematology and Oncology Clinic
🇺🇸Hattiesburg, Mississippi, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
The Valley Hospital, Inc
🇺🇸Paramus, New Jersey, United States
Atrium Health Levine Cancer Institute (Lci)
🇺🇸Charlotte, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
Atrium Health Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States
University Hospitals
🇺🇸Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Penn State Milton S Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
McGlinn Cancer Institute
🇺🇸West Reading, Pennsylvania, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Md Anderson Cancer Center
🇺🇸Houston, Texas, United States
Texas Oncology Austin Midtown
🇺🇸Round Rock, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Virgina Cancer Specialists
🇺🇸Gainesville, Virginia, United States
Vcu Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Northwest Cancer Specialist, Pc(Us Oncology Research)
🇺🇸Vancouver, Washington, United States
Hospital Aleman
🇦🇷Caba, Argentina
FUNDALEU
🇦🇷Caba, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Hospital Universitario de Cordoba
🇦🇷Cordoba, Argentina
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Genesiscare North Shore
🇦🇺St Leonards, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Sunshine Coast Hospital and Health Service
🇦🇺Birtinya, Queensland, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Rockingham Hospital
🇦🇺Cooloongup, Western Australia, Australia
Linear Clinical Research
🇦🇺Nedlands, Western Australia, Australia
One Clinical Research
🇦🇺Nedlands, Western Australia, Australia
Perth Blood Institute
🇦🇺West Perth, Western Australia, Australia
Ordensklinikum Linz Gmbh Elisabethinen
🇦🇹Linz, Austria
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
🇦🇹Salzburg, Austria
Uk St Poelten
🇦🇹St Polten, Austria
Medical University Vienna Oncology
🇦🇹Wien, Austria
Fundacao Pio Xii Hospital de Amor de Barretos
🇧🇷Barretos, Brazil
Hospital Felicio Rocho
🇧🇷Belo Horizonte, Brazil
Universidade de Campinas Centro de Hematologia E Hemoterapia
🇧🇷Campinas, Brazil
Hospital Erasto Gaertner
🇧🇷Curitiba, Brazil
Instituto Joinvilense de Hematologia E Oncologia
🇧🇷Joinville, Brazil
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
🇧🇷Petropolis, Brazil
Hospital de Clinicas de Porto Alegre
🇧🇷Porto AlegreRS, Brazil
Hospital Do Cancer de Pernambuco
🇧🇷Recife, Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
🇧🇷Sao Paulo, Brazil
Hospital Santa Rita de Cassia Afecc
🇧🇷Vitoria, Brazil
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Sun Yat Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Jiangxi Province Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
Liaoning Cancer Hospital and Institute
🇨🇳Shenyang, Liaoning, China
Shaanxi Provincial Peoples Hospital
🇨🇳Xian, Shaanxi, China
Linyi Cancer Hospital
🇨🇳Linyi, Shandong, China
The Affiliated Hospital of Qingdao University Branch West Coast
🇨🇳Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Aidport Sp Z O O
🇵🇱Dopiewo, Poland
Pratia McM Krakow
🇵🇱Krakow, Poland
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Chu Montpellier Hopital Saint Eloi
🇫🇷Montpellier, France
Centre Hospitalier Universitaire Nantes Hotel Dieu
🇫🇷Nantes, France
Chu Hopital Lyon Sud
🇫🇷PierreBenite, France
Ico H Duran I Reynals
🇪🇸Barcelona, Spain
Chu Tours Hopital Bretonneau
🇫🇷Tours, France
Klinikum Chemnitz Ggmbh
🇩🇪Chemnitz, Germany
Klinikum Der Johann Wolfgang Goethe Universitat Medizinische Klinik I
🇩🇪Frankfurt am Main, Germany
Universitatsklinikum Halle
🇩🇪Halle Saale, Germany
Universitatsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Dept of Medicine Iii, University Hospitallmu
🇩🇪Munchen, Germany
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
🇩🇪Mutlangen, Germany
Policlinico Sorsola Malpighi, Aou Di Bologna
🇮🇹Bologna, Italy
Ospedale Vito Fazzi, Asl Lecce
🇮🇹Leece, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
🇮🇹Meldola, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
🇮🇹Trieste, Italy
H Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Centroricerche Cliniche Di Verona Srl
🇮🇹Verona, Italy
Aichi Cancer Center Hospital Clinical Oncology
🇯🇵Nagoya, Aichi, Japan
Toyohashi Municipal Hospital
🇯🇵Toyohashishi, Aichi, Japan
Chiba Cancer Center
🇯🇵Chibashi, Chiba, Japan
Matsuyama Red Cross Hospital
🇯🇵Matsuyamashi, Ehime, Japan
Ogaki Municipal Hospital
🇯🇵Ogaki, Gifu, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
🇯🇵Hiroshimashi, Hiroshima, Japan
Kobe City Medical Center General Hospital
🇯🇵KobeShi, Hyogo, Japan
Kagoshima University Hospital
🇯🇵Kagoshimashi, Kagoshima, Japan
Kanagawa Cancer Center
🇯🇵Yokohamashi, Kanagawa, Japan
Tohoku University Hospital
🇯🇵Sendaishi, Miyagi, Japan
Kurashiki Central Hospital
🇯🇵Kurashikishi, Okayama, Japan
Osaka Red Cross Hospital
🇯🇵Osakashi, Osaka, Japan
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Dokkyo Medical University Saitama Medical Center
🇯🇵Koshigaya, Saitama, Japan
National Hospital Organization Okayama Medical Center
🇯🇵Okayama, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka, Japan
Institute of Science Tokyo Hospital
🇯🇵Tokyo, Japan
Yokohama Municipal Citizens Hospital
🇯🇵YokohamaShi, Japan
Pusan National University Hospital
🇰🇷SeoGu, Busan Gwang'yeogsi, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷BundangGu SeongnamSi, Gyeonggi-do, Korea, Republic of
Samsung Medical Center
🇰🇷GangnamGu, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷SeodaemunGu, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul Saint Marys Hospital (Pharmacy)
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center
🇰🇷SongpaGu, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Yeouido St Marys Hospital
🇰🇷YeongdeungpoGu, Seoul Teugbyeolsi, Korea, Republic of
North Shore Hospital
🇳🇿Auckland, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Tauranga Hospital
🇳🇿Tauranga, New Zealand
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
🇵🇱OD, Poland
Lower Silesian Center of Oncology, Pulmonology and Hematology
🇵🇱Wrocaw, Poland
Auxilio Mutuo Cancer Center
🇵🇷San Juan, Puerto Rico
Etlik City Hospital
🇹🇷Ankara, Turkey
Antalya Memorial Hospital
🇹🇷Dokuma, Turkey
Tr Trakya University Health Research and Application Center (Hospital)
🇹🇷Edirne, Turkey
Kocaeli Universitesi Tip Fakultesi
🇹🇷Kocaeli, Turkey
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
🇬🇧Bournemouth, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Churchill Hospital Oxford University Hospital Nhs Trust
🇬🇧Headington, United Kingdom
University College Hospital
🇬🇧London, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Clatterbridge Cancer Centre
🇬🇧Wirral, United Kingdom