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 (72) 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
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
Illinois
Illinois Cancer Specialists (Niles) Usor
RECRUITING
Niles
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
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
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
Tennessee
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
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
Hanusch Krankenhaus
RECRUITING
Vienna
Brazil
CETUS
RECRUITING
Belo Horizonte
Universidade de Campinas Centro de Hematologia E Hemoterapia
RECRUITING
Campinas
Hospital Erasto Gaertner
RECRUITING
Curitiba
Complexo Hospitalar de Niteroi
RECRUITING
Niterói
Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre
RECRUITING
Porto Alegre
Hospital Sao Lucas
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
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
France
Hopital de La Pitie Salpetriere
RECRUITING
Paris
Germany
Osp Kurfuerstendamm
RECRUITING
Berlin
Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
RECRUITING
Jena
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
RECRUITING
Mutlangen
Dietrich Bonhoeffer Klinikum Neubrandenburg
RECRUITING
Neubrandenburg
Haematologisch Onkologische Schwerpunktpraxis
RECRUITING
Würzburg
Italy
Ospedale San Raffaele
RECRUITING
Milan
Netherlands
Albert Schweitzer Ziekenhuis
RECRUITING
Dordrecht
New Zealand
Auckland City Hospital
RECRUITING
Auckland
North Shore Hospital
RECRUITING
Auckland
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
RECRUITING
Barcelona
Hospital de La Princesa
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
Contact Information
Primary
Study Director
clinicaltrials@beigene.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: BeiGene
Collaborators: German CLL Study Group