A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
Status: Recruiting
Location: See all (148) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama At Birmingham Hospital
RECRUITING
Birmingham
Arizona
Mayo Clinic Phoenix
RECRUITING
Phoenix
Connecticut
Yale University, Yale Cancer Center
RECRUITING
New Haven
Florida
Memorial Cancer Institute, Memorial Healthcare System
RECRUITING
Pembroke Pines
Cleveland Clinic Florida
RECRUITING
Weston
Iowa
Mission Cancer and Blood
RECRUITING
Waukee
Illinois
Rush University Medical Center
NOT_YET_RECRUITING
Chicago
Indiana
Fort Wayne Medical Oncology and Hematology
RECRUITING
Fort Wayne
Massachusetts
Dana Farber Cancer Institute Longwood Medical Center
RECRUITING
Boston
Maryland
University of Maryland Greenebaum Comprehensive Cancer Center
RECRUITING
Baltimore
Michigan
University of Michigan
NOT_YET_RECRUITING
Ann Arbor
The Cancer and Hematology Centers
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Mississippi
Hattiesburg Hematology and Oncology Clinic
RECRUITING
Hattiesburg
North Carolina
Atrium Health Levine Cancer Institute (Lci)
RECRUITING
Charlotte
Duke University
NOT_YET_RECRUITING
Durham
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
New Jersey
The Valley Hospital, Inc
RECRUITING
Paramus
Ohio
Cleveland Clinic Foundation
NOT_YET_RECRUITING
Cleveland
University Hospitals
RECRUITING
Cleveland
Ohio Health Research Institute
RECRUITING
Columbus
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Pennsylvania
Penn State Milton S Hershey Medical Center
RECRUITING
Hershey
McGlinn Cancer Institute
RECRUITING
West Reading
Tennessee
Tennesse Oncology Chattanooga Downtown
RECRUITING
Chattanooga
Tennessee Oncology
RECRUITING
Nashville
Texas
Md Anderson Cancer Center
RECRUITING
Houston
Texas Oncology Austin Midtown
RECRUITING
Round Rock
Virginia
University of Virginia
RECRUITING
Charlottesville
Virgina Cancer Specialists
RECRUITING
Gainesville
Vcu Massey Cancer Center
RECRUITING
Richmond
Washington
Northwest Cancer Specialist, Pc(Us Oncology Research)
RECRUITING
Vancouver
Other Locations
Argentina
FUNDALEU
NOT_YET_RECRUITING
Caba
Hospital Aleman
RECRUITING
Caba
Hospital Italiano de Buenos Aires
NOT_YET_RECRUITING
Ciudad Autonoma Buenos Aires
Hospital Universitario de Cordoba
NOT_YET_RECRUITING
Córdoba
Australia
Sunshine Coast Hospital and Health Service
RECRUITING
Birtinya
Box Hill Hospital
RECRUITING
Box Hill
Monash Health
NOT_YET_RECRUITING
Clayton
Concord Repatriation General Hospital
RECRUITING
Concord
Rockingham Hospital
RECRUITING
Cooloongup
Linear Clinical Research
RECRUITING
Nedlands
One Clinical Research
RECRUITING
Nedlands
Genesiscare North Shore
RECRUITING
St Leonards
Perth Blood Institute
RECRUITING
West Perth
Westmead Hospital
RECRUITING
Westmead
Austria
Ordensklinikum Linz Gmbh Elisabethinen
RECRUITING
Linz
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
RECRUITING
Salzburg
Uk St Poelten
RECRUITING
Sankt Pölten
Medical University Vienna Oncology
NOT_YET_RECRUITING
Vienna
Brazil
Fundacao Pio Xii Hospital de Amor de Barretos
RECRUITING
Barretos
Hospital Felicio Rocho
RECRUITING
Belo Horizonte
Universidade de Campinas Centro de Hematologia E Hemoterapia
RECRUITING
Campinas
Hospital Erasto Gaertner
RECRUITING
Curitiba
Instituto Joinvilense de Hematologia E Oncologia
RECRUITING
Joinville
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
RECRUITING
Petrópolis
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegrers
Hospital Do Cancer de Pernambuco
RECRUITING
Recife
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
RECRUITING
São Paulo
Hospital Santa Rita de Cassia Afecc
RECRUITING
Vitória
China
Beijing Cancer Hospital
RECRUITING
Beijing
Beijing Hospital
RECRUITING
Beijing
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
Sun Yat Sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Linyi Cancer Hospital
RECRUITING
Linyi
Jiangxi Province Cancer Hospital
RECRUITING
Nanchang
Jiangsu Province Hospital
RECRUITING
Nanjing
The Affiliated Hospital of Qingdao University Branch West Coast
RECRUITING
Qingdao
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Liaoning Cancer Hospital and Institute
RECRUITING
Shenyang
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Shaanxi Provincial Peoples Hospital
RECRUITING
Xi'an
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
France
Chu Montpellier Hopital Saint Eloi
RECRUITING
Montpellier
Centre Hospitalier Universitaire Nantes Hotel Dieu
RECRUITING
Nantes
Chu Hopital Lyon Sud
RECRUITING
Pierrebenite
Chu Tours Hopital Bretonneau
RECRUITING
Tours
Germany
Klinikum Chemnitz Ggmbh
NOT_YET_RECRUITING
Chemnitz
Klinikum Der Johann Wolfgang Goethe Universitat
NOT_YET_RECRUITING
Frankfurt Am Main
Universitatsklinikum Halle
NOT_YET_RECRUITING
Halle
Universitatsklinikum Hamburg Eppendorf
NOT_YET_RECRUITING
Hamburg
Dept of Medicine Iii, University Hospitallmu
NOT_YET_RECRUITING
München
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
RECRUITING
Mutlangen
Italy
Policlinico Sorsola Malpighi, Aou Di Bologna
RECRUITING
Bologna
Ospedale Vito Fazzi, Asl Lecce
RECRUITING
Leece
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
RECRUITING
Meldola
Azienda Sanitaria Universitaria Giuliano Isontina
RECRUITING
Trieste
Centroricerche Cliniche Di Verona Srl
RECRUITING
Verona
Japan
Chiba Cancer Center
RECRUITING
Chiba
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
RECRUITING
Hiroshima
Kagoshima University Hospital
RECRUITING
Kagoshima
Kobe City Medical Center General Hospital
RECRUITING
Kobeshi
Dokkyo Medical University Saitama Medical Center
RECRUITING
Koshigaya
Kurashiki Central Hospital
RECRUITING
Kurashikishi
Matsuyama Red Cross Hospital
RECRUITING
Matsuyama
Aichi Cancer Center Hospital Clinical Oncology
RECRUITING
Nagoya
Ogaki Municipal Hospital
RECRUITING
Ōgaki
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Osaka Red Cross Hospital
RECRUITING
Osakashi
Hokkaido University Hospital
RECRUITING
Sapporo
Tohoku University Hospital
NOT_YET_RECRUITING
Sendai
Institute of Science Tokyo Hospital
RECRUITING
Tokyo
Toyohashi Municipal Hospital
RECRUITING
Toyohashishi
Kanagawa Cancer Center
RECRUITING
Yokohama
Yokohama Municipal Citizens Hospital
RECRUITING
Yokohama
New Zealand
North Shore Hospital
RECRUITING
Auckland
Christchurch Hospital
RECRUITING
Christchurch
Dunedin Hospital
RECRUITING
Dunedin
Tauranga Hospital
RECRUITING
Tauranga
Wellington Regional Hospital (Ccdhb)
NOT_YET_RECRUITING
Wellington
Poland
Pratia McM Krakow
RECRUITING
Krakow
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny Nr W Lublinie
RECRUITING
Lublin
Aidport Sp Z O O
RECRUITING
Skorzewo
Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii
NOT_YET_RECRUITING
Wroclaw
Puerto Rico
Auxilio Mutuo Cancer Center
RECRUITING
San Juan
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Bundanggu Seongnamsi
Samsung Medical Center
RECRUITING
Gangnamgu
The Catholic University of Korea, Seoul St Marys Hospital
RECRUITING
Seochogu
Severance Hospital Yonsei University Health System
RECRUITING
Seodaemungu
Pusan National University Hospital
RECRUITING
Seogu
Seoul National University Hospital
RECRUITING
Seoul
Asan Medical Center
RECRUITING
Songpagu
The Catholic University of Korea, Yeouido St Marys Hospital
RECRUITING
Yeongdeungpo-gu
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Ico H Duran I Reynals
RECRUITING
Barcelona
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
H Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Turkey
Etlik City Hospital
NOT_YET_RECRUITING
Ankara
Antalya Memorial Hospital
RECRUITING
Dokuma
Kocaeli Universitesi Tip Fakultesi
RECRUITING
Kocaeli
United Kingdom
Birmingham Heartlands Hospital
NOT_YET_RECRUITING
Birmingham
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
RECRUITING
Bournemouth
Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
Churchill Hospital Oxford University Hospital Nhs Trust
RECRUITING
Headington
University College Hospital
RECRUITING
London
Clatterbridge Cancer Centre
NOT_YET_RECRUITING
Metropolitan Borough Of Wirral
Derriford Hospital
RECRUITING
Plymouth
Contact Information
Primary
Study Director
clinicaltrials@beigene.com
1.877.828.5568
Time Frame
Start Date: 2025-03-05
Estimated Completion Date: 2032-10-30
Participants
Target number of participants: 300
Treatments
Experimental: Arm A: sonrotoclax plus zanubrutinib
Sonrotoclax and zanubrutinib will be administered in combination.
Placebo_comparator: Arm B: placebo plus zanubrutinib
Placebo and zanubrutinib will be administered in combination.
Related Therapeutic Areas
Sponsors
Leads: BeiGene