A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Status: Recruiting
Location: See all (174) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
• Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy
• Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
• Adequate organ function
Locations
United States
California
Chao Family Comprehensive Cancer Center
NOT_YET_RECRUITING
Orange
Stanford Cancer Institute
RECRUITING
Palo Alto
Scripps Prebys Cancer Center
NOT_YET_RECRUITING
San Diego
Colorado
Rocky Mountain Cancer Centers (Williams) Usor
RECRUITING
Aurora
Connecticut
Yale University, Yale Cancer Center
NOT_YET_RECRUITING
New Haven
Eastern Connecticut Hematology and Oncology
RECRUITING
Norwich
Florida
Cleveland Clinic Florida
NOT_YET_RECRUITING
Weston
Iowa
Mission Cancer and Blood
NOT_YET_RECRUITING
Waukee
Illinois
Northwestern University
NOT_YET_RECRUITING
Chicago
Illinois Cancer Specialists (Niles) Usor
NOT_YET_RECRUITING
Niles
Kentucky
University of Louisville, Brown Cancer Center
NOT_YET_RECRUITING
Louisville
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Massachusetts
Dana Farber Cancer Institute
NOT_YET_RECRUITING
Boston
Maryland
University of Maryland Greenebaum Comprehensive Cancer Center
NOT_YET_RECRUITING
Baltimore
Michigan
The Cancer and Hematology Centers
NOT_YET_RECRUITING
Grand Rapids
Minnesota
Mayo Clinic Rochester
NOT_YET_RECRUITING
Rochester
North Carolina
University of North Carolina At Chapel Hill
NOT_YET_RECRUITING
Chapel Hill
Levine Cancer Center
RECRUITING
Charlotte
New York
Memorial Sloan Kettering Cancer Center Mskcc
NOT_YET_RECRUITING
New York
Clinical Research Alliance, Inc
RECRUITING
Westbury
Ohio
Oncology Hematology Care Clinical Trials, Llc
NOT_YET_RECRUITING
Cincinnati
Oregon
Oncology Associates of Oregon Willamette Valley Cancer Center
RECRUITING
Eugene
Pennsylvania
Penn State Milton S Hershey Medical Center
NOT_YET_RECRUITING
Hershey
Thomas Jefferson University
NOT_YET_RECRUITING
Philadelphia
Upmc Hillman Cancer Center(Univ of Pittsburgh)
NOT_YET_RECRUITING
Pittsburgh
Tennessee
Tennessee Oncology
RECRUITING
Nashville
Texas
Texas Oncology Baylorcharles A Sammons Cancer Center
NOT_YET_RECRUITING
Dallas
Ut Southwestern Medical Center
NOT_YET_RECRUITING
Dallas
Texas Oncology San Antonio Medical Center Usor
RECRUITING
San Antonio
Texas Oncology Tyler
NOT_YET_RECRUITING
Tyler
Washington
Northwest Cancer Specialist, Pc(Us Oncology Research)
RECRUITING
Vancouver
Other Locations
Argentina
FUNDALEU
NOT_YET_RECRUITING
Caba
Hospital Aleman
NOT_YET_RECRUITING
Caba
Instituto Alexander Fleming (Iaf)
NOT_YET_RECRUITING
Ciudad Autonoma Buenos Aires
Australia
Sunshine Coast Hospital and Health Service
RECRUITING
Birtinya
Blacktown Cancer and Haematology Centre
RECRUITING
Blacktown
Monash Health
RECRUITING
Clayton
Rockingham Hospital
RECRUITING
Cooloongup
St Vincents Hospital Melbourne
RECRUITING
Fitzroy
St George Hospital
RECRUITING
Kogarah
Northern Nsw Health District
RECRUITING
Lismore
Peter Maccallum Cancer Centre
RECRUITING
Melbourne
The Alfred Hospital
RECRUITING
Melbourne
Macquarie University
RECRUITING
North Ryde
Genesiscare North Shore
RECRUITING
St Leonards
Perth Blood Institute
NOT_YET_RECRUITING
West Perth
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Medizinische Universitatsklinik Innsbruck
NOT_YET_RECRUITING
Innsbruck
Hanusch Krankenhaus
NOT_YET_RECRUITING
Vienna
Medical University Vienna Oncology
NOT_YET_RECRUITING
Vienna
Belgium
Cliniques Universitaires Saint Luc
NOT_YET_RECRUITING
Brussels
Uz Antwerpen
NOT_YET_RECRUITING
Edegem
University Hospitals Leuven
NOT_YET_RECRUITING
Leuven
Brazil
CETUS
RECRUITING
Belo Horizonte
Universidade de Campinas Centro de Hematologia E Hemoterapia
NOT_YET_RECRUITING
Campinas
Hospital Erasto Gaertner
RECRUITING
Curitiba
Complexo Hospitalar de Niteroi
NOT_YET_RECRUITING
Niterói
Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre
RECRUITING
Porto Alegre
Hospital Sao Lucas
NOT_YET_RECRUITING
Rio De Janeiro
Instituto Dor de Pesquisa E Ensino Rio de Janeiro
RECRUITING
Rio De Janeiro
Hospital Santa Izabel
RECRUITING
Salvador
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
RECRUITING
São Paulo
Hospital Nove de Julho Dasa
NOT_YET_RECRUITING
São Paulo
Hospital Samaritano Sao Paulo
RECRUITING
São Paulo
Instituto Brasileiro de Controle Do Cancer
RECRUITING
São Paulo
Instituto Dor de Pesquisa E Ensino Sao Paulo
RECRUITING
São Paulo
Hospital Santa Rita de Cassia Afecc
RECRUITING
Vitória
Canada
Arthur Je Child Comprehensive Cancer Centre
NOT_YET_RECRUITING
Calgary
Cross Cancer Institute
NOT_YET_RECRUITING
Edmonton
Ciusss Nim Hscm
NOT_YET_RECRUITING
Montreal
The Ottawa Hospital
NOT_YET_RECRUITING
Ottawa
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
NOT_YET_RECRUITING
Québec
Newfoundland and Labrador Health Services
NOT_YET_RECRUITING
St. John's
Princess Margaret Cancer Centre
NOT_YET_RECRUITING
Toronto
British Columbia Cancer Agency the Vancouver Centre
NOT_YET_RECRUITING
Vancouver
Cancercare Manitoba
NOT_YET_RECRUITING
Winnipeg
China
China Japan Friendship Hospital
NOT_YET_RECRUITING
Beijing
Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
Fujian Medical University Union Hospitalqishan Branch
NOT_YET_RECRUITING
Fuzhou
Fujian Provincial Hospital
NOT_YET_RECRUITING
Fuzhou
Guangzhou First Peoples Hospital
NOT_YET_RECRUITING
Guangzhou
Nanfang Hospital, Southern Medical University
NOT_YET_RECRUITING
Guangzhou
The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohhot
Shandong Provincial Hospital
NOT_YET_RECRUITING
Jinan
Jining No Peoples Hospital West Branch
NOT_YET_RECRUITING
Jining
Jiangxi Cancer Hospital
NOT_YET_RECRUITING
Nanchang
Zhongda Hospital Southeast University
NOT_YET_RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital Wuxiang Branch
NOT_YET_RECRUITING
Nanning
The Affiliated Peoples Hospital of Ningbo University
NOT_YET_RECRUITING
Ningbo
The Affiliated Hospital of Qingdao University Branch West Coast
NOT_YET_RECRUITING
Qingdao
Affiliated Zhongshan Hospital of Fudan University
NOT_YET_RECRUITING
Shanghai
Liaoning Cancer Hospital and Institute
NOT_YET_RECRUITING
Shenyang
Suzhou Municipal Hospitalbaita Branch
NOT_YET_RECRUITING
Suzhou
Taizhou Hospital of Zhejiang Province (East)
NOT_YET_RECRUITING
Taizhou
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
NOT_YET_RECRUITING
Tianjin
Affiliated Hospital of Jiangnan University South Campus
NOT_YET_RECRUITING
Wuxi
Shaanxi Provincial Peoples Hospital
NOT_YET_RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Northern Jiangsu Peoples Hospital
NOT_YET_RECRUITING
Yangzhou
Denmark
University Hospital of Aalborg, Denmark
NOT_YET_RECRUITING
Aalborg
Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Odense University Hospital
NOT_YET_RECRUITING
Odense C
Zealand University Hospital, Roskilde
NOT_YET_RECRUITING
Roskilde
France
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
NOT_YET_RECRUITING
Clermontferrand
Centre Hospitalier Universitaire Nantes Hotel Dieu
NOT_YET_RECRUITING
Nantes
Hopital de La Pitie Salpetriere
NOT_YET_RECRUITING
Paris
Chu Hopital Lyon Sud
NOT_YET_RECRUITING
Pierrebenite
Hopital Robert Debre
NOT_YET_RECRUITING
Reims
Chu Rennes
NOT_YET_RECRUITING
Rennes Cedes
Centre Henri Becquerel
NOT_YET_RECRUITING
Rouen
Iuct Oncopole
NOT_YET_RECRUITING
Toulouse
Chu Nancy Hopital Brabois
NOT_YET_RECRUITING
Vandoeuvrelesnancy
Germany
Osp Kurfuerstendamm
NOT_YET_RECRUITING
Berlin
Uniklinik Koeln (Aoer)
NOT_YET_RECRUITING
Cologne
Gokos Gmbh
NOT_YET_RECRUITING
Dresden
Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
NOT_YET_RECRUITING
Jena
Universitatsklinikum Schleswig Holstein, Campus Kiel
NOT_YET_RECRUITING
Kiel
Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii
NOT_YET_RECRUITING
München
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
NOT_YET_RECRUITING
Mutlangen
Dietrich Bonhoeffer Klinikum Neubrandenburg
NOT_YET_RECRUITING
Neubrandenburg
Medizinische Universitaetsklinik
NOT_YET_RECRUITING
Tübingen
Universitaetsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Haematologisch Onkologische Schwerpunktpraxis
NOT_YET_RECRUITING
Würzburg
Ireland
Mater Misericordiae University Hospital
NOT_YET_RECRUITING
Dublin
St Jamess Hospital
NOT_YET_RECRUITING
Dublin
University Hospital Galway
NOT_YET_RECRUITING
Galway
University Hospital Limerick
NOT_YET_RECRUITING
Limerick
Italy
Azienda Ospedaliera Policlinico Di Bari
NOT_YET_RECRUITING
Bari
Ao Brotzu Ospedale Oncologico Armando Businco
NOT_YET_RECRUITING
Cagliari
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
NOT_YET_RECRUITING
Catania
Azienda Ospedaliero Universitaria Di Ferrara
NOT_YET_RECRUITING
Ferrara
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
NOT_YET_RECRUITING
Milan
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
NOT_YET_RECRUITING
Modena
Asl Salerno Andrea Tortora
NOT_YET_RECRUITING
Pagani
Netherlands
Flevoziekenhuis
NOT_YET_RECRUITING
Almere Stad
Rijnstate
NOT_YET_RECRUITING
Arnhem
Albert Schweitzer Ziekenhuis
NOT_YET_RECRUITING
Dordrecht
Tergooi Mc
NOT_YET_RECRUITING
Hilversum
New Zealand
Auckland City Hospital
RECRUITING
Auckland
North Shore Hospital
RECRUITING
Auckland
Poland
Uniwersyteckie Centrum Kliniczne
NOT_YET_RECRUITING
Gdansk
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
NOT_YET_RECRUITING
Lodz
Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
NOT_YET_RECRUITING
Torun
Centralny Szpital Kliniczny Uck Wum
NOT_YET_RECRUITING
Warsaw
Uniwersytecki Szpital Kliniczny Hematology
NOT_YET_RECRUITING
Wroclaw
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Bundanggu Seongnamsi
Samsung Medical Center
RECRUITING
Gangnamgu
National Cancer Center (Korea)
RECRUITING
Ilsandonggu Goyangsi
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
Spain
Hospital Clinic de Barcelona
NOT_YET_RECRUITING
Barcelona
Vall D Hebron Institute of Oncology Vhio
NOT_YET_RECRUITING
Barcelona
Ico Lhospitalet Hospital Duran I Reynals
NOT_YET_RECRUITING
Lhospitalet De Llobregat
Hospital de La Princesa
NOT_YET_RECRUITING
Madrid
Hospital Universitario Infanta Leonor
NOT_YET_RECRUITING
Madrid
Costa Del Sol (Marbella, Malaga)
NOT_YET_RECRUITING
Marbella
Hospital Universitario de Salamanca
NOT_YET_RECRUITING
Salamanca
Hospital Universitario Marques de Valdecilla
NOT_YET_RECRUITING
Santander
Hospital Virgen de Valme (Sevilla)
NOT_YET_RECRUITING
Seville
Sweden
Sahlgrenska University Hospital Hematology
NOT_YET_RECRUITING
Gothenburg
Skanes Universitetssjukhus I Lund
NOT_YET_RECRUITING
Lund
Karolinska Universitetssjukhuset Solna
NOT_YET_RECRUITING
Stockholm
Uppsala Akademiska Sjukhus
NOT_YET_RECRUITING
Uppsala
United Kingdom
University Hospitals Dorset Royal Bournemouth Hospital
NOT_YET_RECRUITING
Bournemouth
Churchill Hospital Oxford University Hospital Nhs Trust
NOT_YET_RECRUITING
Headington
St Jamess University Hospital
NOT_YET_RECRUITING
Leeds
Kings College Hospital
NOT_YET_RECRUITING
London
Clatterbridge Cancer Centre
NOT_YET_RECRUITING
Metropolitan Borough Of Wirral
Freeman Hospital
NOT_YET_RECRUITING
Newcastle Upon Tyne
Royal Cornwall Hospitalsnhs Trust
NOT_YET_RECRUITING
Truro
Contact Information
Primary
Study Director
clinicaltrials@beigene.com
1-877-828-5568
Time Frame
Start Date: 2025-06-11
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 630
Treatments
Experimental: Arm A: Sonrotoclax plus Obinutuzumab
Sonrotoclax and obinutuzumab will be administered in combination.
Experimental: Arm B: Sonrotoclax plus Rituximab
Sonrotoclax and rituximab will be administered in combination.
Experimental: Arm C: Sonrotoclax plus Obinutuzumab (MRD)
Sonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD).
Active_comparator: Arm D: Venetoclax plus Rituximab
Venetoclax and rituximab will be administered in combination.
Related Therapeutic Areas
Sponsors
Leads: BeiGene
Collaborators: German CLL Study Group