Clinical trial NCT06742996: 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
Official title: A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Mantle Cell Lymphoma
B Cell Lymphoma
Keywords: mantle cell lymphoma
MCL
relapsed/refractory mantle cell lymphoma
sonrotoclax
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
timeFrame: Approximately 49 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately 92 months
measure: PFS as assessed by investigator (INV)
timeFrame: Approximately 66 months
measure: Overall Response Rate (ORR) as assessed by BIRC and by INV
timeFrame: Approximately 66 months
measure: Duration of Response (DOR) as assessed by BIRC and by INV
timeFrame: Approximately 66 months
measure: Complete Response Rate (CRR) as assessed by BIRC and by INV
timeFrame: Approximately 66 months
measure: Time to first response as assessed by BIRC and by INV
timeFrame: Approximately 66 months
measure: Time to initiation of new anticancer therapy
timeFrame: Approximately 66 months
measure: 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)
timeFrame: Approximately 66 months
measure: 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)
timeFrame: Approximately 66 months
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 66 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham Hospital
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Phoenix
state: Arizona
city: New Haven
country: United States
facility: Yale University, Yale Cancer Center
state: Connecticut
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute, Memorial Healthcare System
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Waukee
country: United States
facility: Mission Cancer and Blood
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute Longwood Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: The Cancer and Hematology Centers
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Hematology and Oncology Clinic
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Paramus
country: United States
facility: The Valley Hospital, Inc
state: New Jersey
city: Charlotte
country: United States
facility: Atrium Health Levine Cancer Institute (Lci)
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: West Reading
country: United States
facility: McGlinn Cancer Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
city: Round Rock
country: United States
facility: Texas Oncology Austin Midtown
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Gainesville
country: United States
facility: Virgina Cancer Specialists
state: Virginia
city: Richmond
country: United States
facility: Vcu Massey Cancer Center
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialist, Pc(Us Oncology Research)
state: Washington
city: Caba
country: Argentina
facility: Hospital Aleman
city: Caba
country: Argentina
facility: FUNDALEU
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Cordoba
country: Argentina
facility: Hospital Universitario de Cordoba
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Genesiscare North Shore
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast Hospital and Health Service
state: Queensland
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Cooloongup
country: Australia
facility: Rockingham Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Nedlands
country: Australia
facility: One Clinical Research
state: Western Australia
city: West Perth
country: Australia
facility: Perth Blood Institute
state: Western Australia
city: Linz
country: Austria
facility: Ordensklinikum Linz Gmbh Elisabethinen
city: Salzburg
country: Austria
facility: Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
city: St Polten
country: Austria
facility: Uk St Poelten
city: Wien
country: Austria
facility: Medical University Vienna Oncology
city: Barretos
country: Brazil
facility: Fundacao Pio Xii Hospital de Amor de Barretos
city: Belo Horizonte
country: Brazil
facility: Hospital Felicio Rocho
city: Campinas
country: Brazil
facility: Universidade de Campinas Centro de Hematologia E Hemoterapia
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
city: Joinville
country: Brazil
facility: Instituto Joinvilense de Hematologia E Oncologia
city: Petropolis
country: Brazil
facility: Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
city: Porto AlegreRS
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
city: Recife
country: Brazil
facility: Hospital Do Cancer de Pernambuco
city: Sao Paulo
country: Brazil
facility: Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
city: Vitoria
country: Brazil
facility: Hospital Santa Rita de Cassia Afecc
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Province Cancer Hospital
state: Jiangxi
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Xian
country: China
facility: Shaanxi Provincial Peoples Hospital
state: Shaanxi
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University Branch West Coast
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Montpellier
country: France
facility: Chu Montpellier Hopital Saint Eloi
city: Nantes
country: France
facility: Centre Hospitalier Universitaire Nantes Hotel Dieu
city: PierreBenite
country: France
facility: Chu Hopital Lyon Sud
city: Tours
country: France
facility: Chu Tours Hopital Bretonneau
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz Ggmbh
city: Frankfurt am Main
country: Germany
facility: Klinikum Der Johann Wolfgang Goethe Universitat Medizinische Klinik I
city: Halle Saale
country: Germany
facility: Universitatsklinikum Halle
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg Eppendorf
city: Munchen
country: Germany
facility: Dept of Medicine Iii, University Hospitallmu
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwabisch Gmund Kliniken Ostalb
city: Bologna
country: Italy
facility: Policlinico Sorsola Malpighi, Aou Di Bologna
city: Leece
country: Italy
facility: Ospedale Vito Fazzi, Asl Lecce
city: Meldola
country: Italy
facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina
city: Verona
country: Italy
facility: Centroricerche Cliniche Di Verona Srl
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital Clinical Oncology
state: Aichi
city: Toyohashishi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi
city: Chibashi
country: Japan
facility: Chiba Cancer Center
state: Chiba
city: Matsuyamashi
country: Japan
facility: Matsuyama Red Cross Hospital
state: Ehime
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Hiroshimashi
country: Japan
facility: Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
state: Hiroshima
city: Sapporoshi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: KobeShi
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kagoshimashi
country: Japan
facility: Kagoshima University Hospital
state: Kagoshima
city: Yokohamashi
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Sendaishi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Kurashikishi
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Osakashi
country: Japan
facility: Osaka Red Cross Hospital
state: Osaka
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center
state: Saitama
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Tokyo
country: Japan
facility: Institute of Science Tokyo Hospital
city: YokohamaShi
country: Japan
facility: Yokohama Municipal Citizens Hospital
city: SeoGu
country: Korea, Republic of
facility: Pusan National University Hospital
state: Busan Gwang'yeogsi
city: BundangGu SeongnamSi
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: GangnamGu
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi
city: SeodaemunGu
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul Saint Marys Hospital (Pharmacy)
state: Seoul Teugbyeolsi
city: SongpaGu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi
city: YeongdeungpoGu
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St Marys Hospital
state: Seoul Teugbyeolsi
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Wellington
country: New Zealand
facility: Wellington Regional Hospital (Ccdhb)
city: Krakow
country: Poland
facility: Pratia McM Krakow
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr W Lublinie
city: OD
country: Poland
facility: Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
city: Skorzewo
country: Poland
facility: Aidport Sp Z O O
city: Wrocaw
country: Poland
facility: Lower Silesian Center of Oncology, Pulmonology and Hematology
city: San Juan
country: Puerto Rico
facility: Auxilio Mutuo Cancer Center
city: Barcelona
country: Spain
facility: Ico H Duran I Reynals
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Majadahonda
country: Spain
facility: H Puerta de Hierro Majadahonda
city: Ankara
country: Turkey
facility: Etlik City Hospital
city: Dokuma
country: Turkey
facility: Antalya Memorial Hospital
city: Edirne
country: Turkey
facility: Tr Trakya University Health Research and Application Center (Hospital)
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Headington
country: United Kingdom
facility: Churchill Hospital Oxford University Hospital Nhs Trust
city: London
country: United Kingdom
facility: University College Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Wirral
country: United Kingdom
facility: Clatterbridge Cancer Centre
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: