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A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
Sponsor: BeOne Medicines
Summary
This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.
Official title: An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of the BCL2 Inhibitor Sonrotoclax (BGB-11417) as Monotherapy and in Combination With Zanubrutinib (BGB-3111) in Patients With Waldenström Macroglobulinemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
114
Start Date
2023-10-23
Completion Date
2028-08
Last Updated
2026-01-02
Healthy Volunteers
No
Conditions
Interventions
Sonrotoclax
Administered orally as a tablet.
Zanubrutinib
Administered orally as a capsule.
Locations (72)
City of Hope National Medical Center
Duarte, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Northwestern Medicine Cancer Center
Warrenville, Illinois, 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
Boston, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Ut Southwestern Medical Center
Dallas, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Genesiscare North Shore
St Leonards, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Flinders Medical Centre
Bedford PK, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
Lions Gate Hospital Chemotherapy Clinic
North Vancouver, British Columbia, Canada
Qeii Health Science Center
Halifax, Nova Scotia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Yancheng First Peoples Hospital
Yancheng, Jiangsu, China
Shengjing Hospital of China Medical Universityshenbei Branch
Shenyang, Liaoning, China
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The Third Peoples Hospital of Datong
Datong, Shanxi, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Centre Hospitalier Universitaire Damiens Hopital Sud
Amiens, France
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
Clermontferrand, France
Institut Paoli Calmettes
Marseille, France
Hopital de La Pitie Salpetriere
Paris, France
Chu Hopital Lyon Sud
PierreBenite, France
Hopital Robert Debre
Reims, France
General Hospital of Athens Alexandra
Athens, Greece
Irccs Azienda Ospedaliero Universitaria Bologna
Bologna, Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, Italy
Istituto Europeo Di Oncologia
Milan, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Pavia, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy
Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Universitario Santa Maria Del
Udine, Italy
Hospital Universitario Vall Dhebron
Barcelona, Spain
Institut Catala Doncologia
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Spain
University Hospitals Dorset
Bournemouth, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Churchill Hospital Oxford University Hospital Nhs Trust
Headington, United Kingdom
Nhs Highland
Inverness, United Kingdom
St Jamess University Hospital
Leeds, United Kingdom
University College Hospital
London, United Kingdom
The Christie Nhs Foundation Trust Manchester
Manchester, United Kingdom
Plymouth Hospitals Nhs Trust
Plymouth, United Kingdom
Royal Marsden Nhs Foundation Royal Marsden Hospital
Sutton, United Kingdom