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A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Sponsor: BeOne Medicines
Summary
The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R\^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R\^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.
Official title: A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
799
Start Date
2022-03-10
Completion Date
2030-06
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
Zanubrutinib
Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day) or four 80-mg capsules once a day (320 mg once a day) continuously in repeated 28-day cycles.
Rituximab
Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. Each cycle is 28 days in length.
Lenalidomide
Lenalidomide will be administered orally as 20-mg capsules (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles.
Obinutuzumab
Obinutuzumab will be administered at a dose of 1000 mg on Cycle 1 Days 1, 8, 15 and then on Cycles 2 to 6 Day 1.
Locations (264)
Ucsf Fresno University of California San Francisco Fresno
Fresno, California, United States
Kaiser Permanente Southern California
Irvine, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Los Angeles Cancer Network
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
UCLA Hematologyoncology
Los Angeles, California, United States
Scripps Health
San Diego, California, United States
Sharp Healthcare Sharp Memorial Hospital
San Diego, California, United States
Baptist Md Anderson Cancer Center
Jacksonville, Florida, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Northwest Georgia Oncology Centers Marietta
Marietta, Georgia, United States
Cancer Care Specialists of Illinois
OFallon, Illinois, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Mission Cancer and Blood
Waukee, Iowa, United States
Cotton Oneil Cancer Center
Topeka, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Christus Highland Cancer Treatment Center
Shreveport, Louisiana, United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, United States
The University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Ascension St Agnes Hospital
Baltimore, Maryland, United States
American Oncology Partners of Maryland Pa
Bethesda, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health the Michigan Cancer Consortium
Grand Rapids, Michigan, United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, United States
University of Missouri Hospital Ellis Fischel Cancer Center
Columbia, Missouri, United States
Oncology Hematology Associates
Springfield, Missouri, United States
St Vincent Frontier Cancer Center
Billings, Montana, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Iyengar Hematology Oncology Medical Center Pa
Bayonne, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, United States
New York Cancer and Blood Specialists
Shirley, New York, United States
Suny Upstate Medical University
Syracuse, New York, United States
North Shore Hematology Oncology Associates Eccc Bronx
The Bronx, New York, United States
Optum Medical Care, Pc
Westbury, New York, United States
Levine Cancer Institute Wake Forest
Charlotte, North Carolina, United States
Oncology Hematology Care Clinical Trials, Llc
Cincinnati, Ohio, United States
Va Northeast Ohio Healthcare System
Cleveland, Ohio, United States
Toledo Clinic Cancer Center
Toledo, Ohio, United States
Mainline Health Lankenau Institute For Medical Research
Wynnewood, Pennsylvania, United States
Cancer Care Associates of York
York, Pennsylvania, United States
Prairie Lakes Healthcare System
Watertown, South Dakota, United States
Tennessee Oncology Nashville St Thomas Midtown Clinic
Nashville, Tennessee, United States
Texas Oncology Baylor Charles A Sammons Cancer Center
Dallas, Texas, United States
Md Anderson Cancer Center
Houston, Texas, United States
Northeast Texas Cancer and Research Institute
Tyler, Texas, United States
University of Washington
Seattle, Washington, United States
Medical Oncology Associates
Spokane, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Hospital Aleman
Caba, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Orange Health Hospital
Orange, New South Wales, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Townsville University Hospital
Douglas, Queensland, Australia
Genesiscare North Adelaide
North Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Epworth Freemasons
East Melbourne, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Cabrini Hospital Malvern
Malvern, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
La Trobe Regional Hospital
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Perth Blood Institute
West Perth, Western Australia, Australia
Medizinische Universitatsklinik Innsbruck
Innsbruck, Austria
Uk St Poelten
Sankt Pölten, Austria
Medical Univeristy Vienna
Vienna, Austria
Hanusch Krankenhaus
Vienna, Austria
Wiener Gesundheitsverbund Klinik Ottakring
Vienna, Austria
Institut Jules Bordet
Anderlecht, Belgium
Az Sint Jan Brugge
Bruges, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
University Hospitals Leuven
Leuven, Belgium
Hospital de Amor Barretos
Barretos, Brazil
Clinica de Oncologia Reichow
Blumenau, Brazil
Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
Botucatu, Brazil
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, Brazil
Universidade de Campinas Centro de Hematologia E Hemoterapia
Campinas, Brazil
Fundacao Universidade de Caxias Do Sul
Caxias do Sul, Brazil
Centro Integrado de Oncologia de Curitiba Ss Cionc
Curitiba, Brazil
Hospital Erasto Gaertner
Curitiba, Brazil
Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
Florianópolis, Brazil
Complexo Hospitalar de Niteroi
Niterói, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil
Instituto Dor de Pesquisa E Ensino Pernambuco
Recife, Brazil
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Ribeirão Preto, Brazil
Instituto Dor de Pesquisa E Ensino Rio de Janeiro
Rio de Janeiro, Brazil
Instituto Americas Ensino, Pesquisa E Inovacao
Rio de Janeiro, Brazil
Hospital Sao Rafael Instituto Dor de Pesquisa E Ensino
Salvador, Brazil
Ensino E Terapia de Inovacao Clinica Amo Etica
Salvador, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
Hospital Nove de Julho Dasa
São Paulo, Brazil
Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil