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 (160) 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
Uci Health Laguna Hills
RECRUITING
Laguna Hills
Chao Family Comprehensive Cancer Center
RECRUITING
Orange
Stanford Cancer Institute
RECRUITING
Palo Alto
Scripps Prebys Cancer Center
RECRUITING
San Diego
Colorado
Rocky Mountain Cancer Centers (Williams) Usor
RECRUITING
Aurora
Connecticut
Yale University, Yale Cancer Center
RECRUITING
New Haven
Eastern Connecticut Hematology and Oncology
RECRUITING
Norwich
Florida
Cleveland Clinic Florida
RECRUITING
Weston
Illinois
Northwestern University
RECRUITING
Chicago
Illinois Cancer Specialists (Niles) Usor
RECRUITING
Niles
Kentucky
University of Louisville, Brown Cancer Center
RECRUITING
Louisville
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Maryland
University of Maryland Greenebaum Comprehensive Cancer Center
RECRUITING
Baltimore
Michigan
The Cancer and Hematology Centers
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
North Carolina
University of North Carolina At Chapel Hill
RECRUITING
Chapel Hill
Levine Cancer Center
RECRUITING
Charlotte
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
New Jersey
Sidney Kimmel Comprehensive Cancer Center Washington Twp
RECRUITING
Sewell
New York
Memorial Sloan Kettering Cancer Center Mskcc
RECRUITING
New York
Clinical Research Alliance, Inc
RECRUITING
Westbury
Ohio
Oncology Hematology Care Clinical Trials, Llc
RECRUITING
Cincinnati
Oregon
Oncology Associates of Oregon Willamette Valley Cancer Center
RECRUITING
Eugene
Pennsylvania
Penn State Milton S Hershey Medical Center
RECRUITING
Hershey
Thomas Jefferson University
RECRUITING
Philadelphia
Upmc Hillman Cancer Center(Univ of Pittsburgh)
RECRUITING
Pittsburgh
Tennessee
Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga
RECRUITING
Chattanooga
Tennessee Oncology
RECRUITING
Nashville
Texas
Texas Oncology Baylorcharles A Sammons Cancer Center
RECRUITING
Dallas
Texas Oncology San Antonio Medical Center Usor
RECRUITING
San Antonio
Texas Oncology Tyler
RECRUITING
Tyler
Washington
Northwest Cancer Specialist, Pc(Us Oncology Research)
RECRUITING
Vancouver
Other Locations
Argentina
FUNDALEU
RECRUITING
Caba
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
RECRUITING
West Perth
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Medizinische Universitatsklinik Innsbruck
RECRUITING
Innsbruck
Hanusch Krankenhaus
RECRUITING
Vienna
Medical University Vienna Oncology
RECRUITING
Vienna
Belgium
Cliniques Universitaires Saint Luc
RECRUITING
Brussels
Uz Antwerpen
RECRUITING
Edegem
University Hospitals Leuven
RECRUITING
Leuven
Brazil
CETUS
ACTIVE_NOT_RECRUITING
Belo Horizonte
Universidade de Campinas Centro de Hematologia E Hemoterapia
ACTIVE_NOT_RECRUITING
Campinas
Hospital Erasto Gaertner
ACTIVE_NOT_RECRUITING
Curitiba
Complexo Hospitalar de Niteroi
ACTIVE_NOT_RECRUITING
Niterói
Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre
ACTIVE_NOT_RECRUITING
Porto Alegre
Hospital Sao Lucas
ACTIVE_NOT_RECRUITING
Rio De Janeiro
Instituto Dor de Pesquisa E Ensino Rio de Janeiro
ACTIVE_NOT_RECRUITING
Rio De Janeiro
Hospital Santa Izabel
ACTIVE_NOT_RECRUITING
Salvador
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
ACTIVE_NOT_RECRUITING
São Paulo
Hospital Nove de Julho Dasa
ACTIVE_NOT_RECRUITING
São Paulo
Hospital Samaritano Sao Paulo
ACTIVE_NOT_RECRUITING
São Paulo
Instituto Brasileiro de Controle Do Cancer
ACTIVE_NOT_RECRUITING
São Paulo
Instituto Dor de Pesquisa E Ensino Sao Paulo
ACTIVE_NOT_RECRUITING
São Paulo
Hospital Santa Rita de Cassia Afecc
ACTIVE_NOT_RECRUITING
Vitória
Canada
Arthur Je Child Comprehensive Cancer Centre
RECRUITING
Calgary
The Ottawa Hospital
RECRUITING
Ottawa
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
RECRUITING
Québec
China
China Japan Friendship Hospital
RECRUITING
Beijing
Xiangya Hospital of Central South University
RECRUITING
Changsha
West China Hospital, Sichuan University
RECRUITING
Chengdu
Fujian Medical University Union Hospitalqishan Branch
RECRUITING
Fuzhou
Fujian Provincial Hospital
RECRUITING
Fuzhou
Guangzhou First Peoples Hospital
RECRUITING
Guangzhou
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
The Affiliated Hospital of Inner Mongolia Medical University
RECRUITING
Hohhot
Shandong Provincial Hospital
RECRUITING
Jinan
Jining No1 Peoples Hospital West Branch
RECRUITING
Jining
Jiangxi Cancer Hospital
RECRUITING
Nanchang
Zhongda Hospital Southeast University
RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital Wuxiang Branch
RECRUITING
Nanning
The Affiliated Peoples Hospital of Ningbo University
RECRUITING
Ningbo
The Affiliated Hospital of Qingdao University Branch West Coast
RECRUITING
Qingdao
Affiliated Zhongshan Hospital of Fudan University
RECRUITING
Shanghai
Liaoning Cancer Hospital and Institute
RECRUITING
Shenyang
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Suzhou Municipal Hospitalbaita Branch
RECRUITING
Suzhou
Taizhou Hospital of Zhejiang Province (East)
RECRUITING
Taizhou
Affiliated Hospital of Jiangnan University South Campus
RECRUITING
Wuxi
Shaanxi Provincial Peoples Hospital
RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Northern Jiangsu Peoples Hospital
RECRUITING
Yangzhou
Denmark
University Hospital of Aalborg
RECRUITING
Aalborg
Rigshospitalet
RECRUITING
Copenhagen
Odense University Hospital
RECRUITING
Odense C
Zealand University Hospital, Roskilde
RECRUITING
Roskilde
France
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
RECRUITING
Clermontferrand
Centre Hospitalier Universitaire Nantes Hotel Dieu
RECRUITING
Nantes
Hopital de La Pitie Salpetriere
RECRUITING
Paris
Chu Hopital Lyon Sud
RECRUITING
Pierrebenite
Hopital Robert Debre
RECRUITING
Reims
Chu Rennes
RECRUITING
Rennes Cedes
Centre Henri Becquerel
RECRUITING
Rouen
Iuct Oncopole
RECRUITING
Toulouse
Chu Nancy Hopital Brabois
RECRUITING
Vandoeuvrelesnancy
Germany
Osp Kurfuerstendamm
RECRUITING
Berlin
Uniklinik Koeln (Aoer)
RECRUITING
Cologne
Gokos Gmbh
RECRUITING
Dresden
Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
RECRUITING
Jena
Universitatsklinikum Schleswig Holstein, Campus Kiel
RECRUITING
Kiel
Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii
RECRUITING
München
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
RECRUITING
Mutlangen
Dietrich Bonhoeffer Klinikum Neubrandenburg
RECRUITING
Neubrandenburg
Medizinische Universitaetsklinik
RECRUITING
Tübingen
Universitaetsklinikum Ulm
RECRUITING
Ulm
Haematologisch Onkologische Schwerpunktpraxis
RECRUITING
Würzburg
Ireland
Mater Misericordiae University Hospital
RECRUITING
Dublin
St Jamess Hospital
RECRUITING
Dublin
University Hospital Galway
RECRUITING
Galway
University Hospital Limerick
RECRUITING
Limerick
Italy
Azienda Ospedaliera Policlinico Di Bari
RECRUITING
Bari
Ao Brotzu Ospedale Oncologico Armando Businco
RECRUITING
Cagliari
Po Grodolico, Aou Policlinico Vittorio Emanuele Di Catania
RECRUITING
Catania
Ospedale San Raffaele
RECRUITING
Milan
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
RECRUITING
Modena
Asl Salerno Andrea Tortora
RECRUITING
Pagani
Netherlands
Flevoziekenhuis
RECRUITING
Almere Stad
Rijnstate
RECRUITING
Arnhem
Albert Schweitzer Ziekenhuis
RECRUITING
Dordrecht
Tergooi Mc
RECRUITING
Hilversum
New Zealand
Auckland City Hospital
RECRUITING
Auckland
North Shore Hospital
RECRUITING
Auckland
Poland
Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
RECRUITING
Torun
Republic of Korea
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 Bundang Hospital
RECRUITING
Seongnam-si
Seoul National University Hospital
RECRUITING
Seoul
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Vall D Hebron Institute of Oncology Vhio
RECRUITING
Barcelona
Ico Lhospitalet Hospital Duran I Reynals
RECRUITING
Lhospitalet De Llobregat
Hospital de La Princesa
RECRUITING
Madrid
Hospital Universitario Infanta Leonor
RECRUITING
Madrid
Costa Del Sol (Marbella, Malaga)
RECRUITING
Marbella
Hospital Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Virgen de Valme (Sevilla)
RECRUITING
Seville
Sweden
Sahlgrenska University Hospital Hematology
RECRUITING
Gothenburg
Skanes Universitetssjukhus I Lund
RECRUITING
Lund
Karolinska Universitetssjukhuset Solna
RECRUITING
Stockholm
Uppsala Akademiska Sjukhus
RECRUITING
Uppsala
United Kingdom
University Hospitals Dorset Royal Bournemouth Hospital
RECRUITING
Bournemouth
Kings College Hospital
RECRUITING
London
Clatterbridge Cancer Centre
RECRUITING
Metropolitan Borough Of Wirral
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Royal Cornwall Hospitalsnhs Trust
RECRUITING
Truro
Contact Information
Primary
Study Director
clinicaltrials@beonemed.com
1-877-828-5568
Time Frame
Start Date: 2025-06-11
Estimated Completion Date: 2031-12
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: BeOne Medicines
Collaborators: German CLL Study Group