A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
• Intervention / Treatment: Drug: Obinutuzumab; Drug: Rituximab; Drug: Sonrotoclax; Drug: Venetoclax

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

• Study Type: Interventional
• Enrollment (Estimated): 630
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1-877-828-5568; Email: clinicaltrials@beonemed.com

Study Locations

• Argentina
  • Caba, Argentina, CP1114
    • Recruiting
    • Fundaleu
  • Ciudad Autonoma Buenos Aires, Argentina, 1426
    • Recruiting
    • Instituto Alexander Fleming (Iaf)
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, NSW 2148
      • Recruiting
      • Blacktown Cancer and Haematology Centre
    • Kogarah, New South Wales, Australia, NSW 2217
      • Recruiting
      • St George Hospital
    • Lismore, New South Wales, Australia, NSW 2480
      • Recruiting
      • Northern Nsw Health District
    • North Ryde, New South Wales, Australia, NSW 2109
      • Recruiting
      • Macquarie University
    • St Leonards, New South Wales, Australia, NSW 2065
      • Recruiting
      • GenesisCare North Shore
  • Queensland
    • Birtinya, Queensland, Australia, QLD 4575
      • Recruiting
      • Sunshine Coast Hospital and Health Service
    • Woolloongabba, Queensland, Australia, QLD 4102
      • Recruiting
      • Princess Alexandra Hospital
  • Victoria
    • Clayton, Victoria, Australia, VIC 3168
      • Recruiting
      • Monash Health
    • Fitzroy, Victoria, Australia, VIC 3065
      • Recruiting
      • St Vincents Hospital Melbourne
    • Melbourne, Victoria, Australia, VIC 3004
      • Recruiting
      • The Alfred Hospital
    • Melbourne, Victoria, Australia, VIC 3000
      • Recruiting
      • Peter MacCallum Cancer Centre
  • Western Australia
    • Cooloongup, Western Australia, Australia, WA 6168
      • Recruiting
      • Rockingham Hospital
    • West Perth, Western Australia, Australia, WA 6005
      • Recruiting
      • Perth Blood Institute
• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
    • Medizinische Universitatsklinik Innsbruck
  • Vienna, Austria, 1140
    • Recruiting
    • Hanusch Krankenhaus
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University Vienna Oncology
• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint Luc
  • Edegem, Belgium, 2650
    • Recruiting
    • UZ Antwerpen
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospitals Leuven
• Brazil
  • Belo Horizonte, Brazil, 30110-022
    • Active, not recruiting
    • CETUS
  • Campinas, Brazil, 13083-878
    • Active, not recruiting
    • Universidade de Campinas Centro de Hematologia E Hemoterapia
  • Curitiba, Brazil, 81520-060
    • Active, not recruiting
    • Hospital Erasto Gaertner
  • Niterói, Brazil, 24020-096
    • Active, not recruiting
    • Complexo Hospitalar de Niteroi
  • Porto Alegre, Brazil, 90020-090
    • Active, not recruiting
    • Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre
  • Rio de Janeiro, Brazil, 22061-080
    • Active, not recruiting
    • Hospital sao lucas
  • Rio de Janeiro, Brazil, 22281-100
    • Active, not recruiting
    • Instituto Dor de Pesquisa E Ensino Rio de Janeiro
  • Salvador, Brazil, 40050-410
    • Active, not recruiting
    • Hospital Santa Izabel
  • São Paulo, Brazil, 04014-002
    • Active, not recruiting
    • Instituto Brasileiro de Controle Do Cancer
  • São Paulo, Brazil, 01409-001
    • Active, not recruiting
    • Hospital Nove de Julho Dasa
  • São Paulo, Brazil, 05402-000
    • Active, not recruiting
    • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
  • São Paulo, Brazil, 01232-010
    • Active, not recruiting
    • Hospital Samaritano Sao Paulo
  • São Paulo, Brazil, 01401-004
    • Active, not recruiting
    • Instituto Dor de Pesquisa E Ensino Sao Paulo
  • Vitória, Brazil, 29043-260
    • Active, not recruiting
    • Hospital Santa Rita de Cassia Afecc
• Canada
  • Québec, Canada, G1J 1Z4
    • Recruiting
    • Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Recruiting
      • Arthur Je Child Comprehensive Cancer Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Recruiting
      • British Columbia Cancer Agency the Vancouver Centre
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Recruiting
      • Newfoundland and Labrador Health Services
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Recruiting
      • Ciusss Nim Hscm
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • China Japan Friendship Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Provincial Hospital
    • Fuzhou, Fujian, China, 350108
      • Recruiting
      • Fujian Medical University Union Hospitalqishan Branch
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
    • Guangzhou, Guangdong, China, 510013
      • Recruiting
      • Guangzhou First Peoples Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530201
      • Recruiting
      • Guangxi Medical University Cancer Hospital Wuxiang Branch
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Second Hospital of Hebei Medical University
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital of Central South University
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010050
      • Recruiting
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital Southeast University
    • Suzhou, Jiangsu, China, 215001
      • Recruiting
      • Suzhou Municipal Hospitalbaita Branch
    • Wuxi, Jiangsu, China, 214122
      • Recruiting
      • Affiliated Hospital of Jiangnan University South Campus
    • Yangzhou, Jiangsu, China, 225001
      • Recruiting
      • Northern Jiangsu Peoples Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Recruiting
      • Jiangxi Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Recruiting
      • Liaoning Cancer Hospital and Institute
  • Shaanxi
    • Xi'an, Shaanxi, China, 710068
      • Recruiting
      • Shaanxi Provincial Peoples Hospital
  • Shandong
    • Jinan, Shandong, China, 250021
      • Recruiting
      • Shandong Provincial Hospital
    • Jining, Shandong, China, 272000
      • Recruiting
      • Jining No1 Peoples Hospital West Branch
    • Qingdao, Shandong, China, 266555
      • Recruiting
      • The Affiliated Hospital of Qingdao University Branch West Coast
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Affiliated Zhongshan Hospital of Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital, Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 301617
      • Recruiting
      • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
  • Zhejiang
    • Ningbo, Zhejiang, China, 315040
      • Recruiting
      • The Affiliated Peoples Hospital of Ningbo University
    • Taizhou, Zhejiang, China, 317004
      • Recruiting
      • Taizhou Hospital of Zhejiang Province (East)
• Czechia
  • Brno, Czechia, 625 00
    • Recruiting
    • Fakultní nemocnice Brno
  • Hradec Králové, Czechia, 500 03
    • Recruiting
    • Fakultni nemocnice Hradec Kralove
  • Prague, Czechia, 10000
    • Recruiting
    • Vseobecna fakultni nemocnice v Praze
  • Prague, Czechia, 128 00
    • Recruiting
    • Ustav Hematologie A Krevni Transfuze (Uhkt)
• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • University Hospital of Aalborg
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
  • Odense C, Denmark, 5000
    • Recruiting
    • Odense University Hospital
  • Roskilde, Denmark, 4000
    • Recruiting
    • Zealand University Hospital, Roskilde
• France
  • ClermontFerrand, France, 63100
    • Recruiting
    • Chu Clermont Ferrand Therapie Cellulaire and Hematolo
  • Nantes, France, 44000
    • Recruiting
    • Centre Hospitalier Universitaire Nantes Hotel Dieu
  • Paris, France, 75013
    • Recruiting
    • Hôpital de la Pitié Salpêtrière
  • PierreBenite, France, 69495
    • Recruiting
    • Chu Hopital Lyon Sud
  • Reims, France, 51100
    • Recruiting
    • Hopital Robert Debre
  • Rennes Cedes, France, 35000
    • Recruiting
    • CHU Rennes
  • Rouen, France, 76038
    • Recruiting
    • Centre Henri Becquerel
  • Toulouse, France, 31100
    • Recruiting
    • IUCT Oncopole
  • VandoeuvrelesNancy, France, 54511
    • Recruiting
    • Chu Nancy Hopital Brabois
• Germany
  • Berlin, Germany, 10707
    • Recruiting
    • Osp Kurfuerstendamm
  • Cologne, Germany, 50937
    • Recruiting
    • Uniklinik Koeln (Aoer)
  • Dresden, Germany, 01307
    • Recruiting
    • Gokos Gmbh
  • Jena, Germany, 07747
    • Recruiting
    • Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
  • Kiel, Germany, 24105
    • Recruiting
    • Universitatsklinikum Schleswig Holstein Campus Kiel
  • Mutlangen, Germany, 73557
    • Recruiting
    • Stauferklinikum Schwabisch Gmund Kliniken Ostalb
  • München, Germany, 81377
    • Recruiting
    • Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii
  • Neubrandenburg, Germany, 17036
    • Recruiting
    • Dietrich Bonhoeffer Klinikum Neubrandenburg
  • Tübingen, Germany, 72076
    • Recruiting
    • Medizinische Universitaetsklinik
  • Ulm, Germany, 89081
    • Recruiting
    • Universitaetsklinikum Ulm
  • Würzburg, Germany, 97080
    • Recruiting
    • Haematologisch Onkologische Schwerpunktpraxis
• Ireland
  • Dublin, Ireland, D7
    • Recruiting
    • Mater Misericordiae University Hospital
  • Dublin, Ireland, D08 NHY1
    • Recruiting
    • St Jamess Hospital
  • Galway, Ireland, H91 YR71
    • Recruiting
    • University Hospital Galway
  • Limerick, Ireland, V94F858
    • Recruiting
    • University Hospital Limerick
• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Azienda Ospedaliera Policlinico Di Bari
  • Cagliari, Italy, 09121
    • Recruiting
    • Ao Brotzu Ospedale Oncologico Armando Businco
  • Catania, Italy, 95123
    • Recruiting
    • Po Grodolico, Aou Policlinico Vittorio Emanuele Di Catania
  • Ferrara, Italy, 44124
    • Recruiting
    • Azienda Ospedaliero Universitaria di Ferrara
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
  • Modena, Italy, 41124
    • Recruiting
    • Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
  • Pagani, Italy, 84014
    • Recruiting
    • Asl Salerno Andrea Tortora
• Netherlands
  • Almere Stad, Netherlands, 1315 RA
    • Recruiting
    • Flevoziekenhuis
  • Arnhem, Netherlands, 6815 AD
    • Recruiting
    • Rijnstate
  • Dordrecht, Netherlands, 3318 AT
    • Recruiting
    • Albert Schweitzer Ziekenhuis
  • Hilversum, Netherlands, 1212 VG
    • Recruiting
    • Tergooi Mc
• New Zealand
  • Auckland, New Zealand, 1023
    • Recruiting
    • Auckland City Hospital
  • Auckland, New Zealand, 0622
    • Recruiting
    • North Shore Hospital
• Poland
  • Torun, Poland, 87-100
    • Recruiting
    • Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
• South Korea
  • Busan Gwang'yeogsi
    • Seogu, Busan Gwang'yeogsi, South Korea, 49241
      • Recruiting
      • Pusan National University Hospital
  • Gyeonggi-do
    • IlsandongGu GoyangSi, Gyeonggi-do, South Korea, 10408
      • Recruiting
      • National Cancer Center (Korea)
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
  • Seoul Teugbyeolsi
    • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
    • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
      • Recruiting
      • The Catholic University of Korea, Seoul St Marys Hospital
    • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
      • Recruiting
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Recruiting
    • Vall D Hebron Institute of Oncology Vhio
  • LHospitalet de Llobregat, Spain, 08908
    • Recruiting
    • Ico Lhospitalet Hospital Duran I Reynals
  • Madrid, Spain, 28031
    • Recruiting
    • Hospital Universitario Infanta Leonor
  • Madrid, Spain, 28006
    • Recruiting
    • Hospital De La Princesa
  • Marbella, Spain, 29603
    • Recruiting
    • Costa Del Sol (Marbella, Malaga)
  • Salamanca, Spain, 37007
    • Recruiting
    • Hospital Universitario de Salamanca
  • Santander, Spain, 39008
    • Recruiting
    • Hospital Universitario Marques de Valdecilla
  • Seville, Spain, 41014
    • Recruiting
    • Hospital Virgen de Valme (Sevilla)
• Sweden
  • Gothenburg, Sweden, 413 46
    • Recruiting
    • Sahlgrenska University Hospital Hematology
  • Lund, Sweden, 221 85
    • Recruiting
    • Skanes Universitetssjukhus I Lund
  • Stockholm, Sweden, 171 76
    • Recruiting
    • Karolinska Universitetssjukhuset Solna
  • Uppsala, Sweden, 751 85
    • Recruiting
    • Uppsala Akademiska Sjukhus
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • Recruiting
    • University Hospitals Dorset Royal Bournemouth Hospital
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • St Jamess University Hospital
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • Kings College Hospital
  • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
    • Recruiting
    • Clatterbridge Cancer Centre
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Recruiting
    • Freeman Hospital
  • Truro, United Kingdom, TR1 3LJ
    • Recruiting
    • Royal Cornwall Hospitalsnhs Trust
• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Recruiting
      • UCI Health Laguna Hills
    • Orange, California, United States, 92868-3201
      • Recruiting
      • Chao Family Comprehensive Cancer Center
    • Palo Alto, California, United States, 94304-2205
      • Recruiting
      • Stanford Cancer Institute
    • San Diego, California, United States, 92103-2106
      • Recruiting
      • Scripps Prebys Cancer Center
  • Colorado
    • Aurora, Colorado, United States, 80012-5405
      • Recruiting
      • Rocky Mountain Cancer Centers (Williams) Usor
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8028
      • Recruiting
      • Yale University Yale Cancer Center
    • Norwich, Connecticut, United States, 06360-2700
      • Recruiting
      • Eastern Connecticut Hematology and Oncology
  • Florida
    • Weston, Florida, United States, 33331-3609
      • Recruiting
      • Cleveland Clinic Florida
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
    • Niles, Illinois, United States, 60714-5905
      • Recruiting
      • Illinois Cancer Specialists (Niles) Usor
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville, Brown Cancer Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809-3738
      • Recruiting
      • Mary Bird Perkins Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21201-1544
      • Recruiting
      • University of Maryland Greenebaum Comprehensive Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5418
      • Recruiting
      • Dana Farber Cancer Institute
  • Michigan
    • Grand Rapids, Michigan, United States, 49503-2563
      • Recruiting
      • The Cancer and Hematology Centers
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Recruiting
      • Mayo Clinic Rochester
  • New Jersey
    • Sewell, New Jersey, United States, 08080
      • Recruiting
      • Sidney Kimmel Comprehensive Cancer Center Washington Twp
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Recruiting
      • Christus St Vincent Regional Cancer Center
  • New York
    • New York, New York, United States, 10065-6800
      • Recruiting
      • Memorial Sloan Kettering Cancer Center Mskcc
    • Westbury, New York, United States, 11590-5119
      • Recruiting
      • Clinical Research Alliance, Inc
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514-4220
      • Recruiting
      • University of North Carolina At Chapel Hill
    • Charlotte, North Carolina, United States, 28204-2990
      • Recruiting
      • Levine Cancer Center
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist
  • Ohio
    • Cincinnati, Ohio, United States, 45245-1995
      • Recruiting
      • Oncology Hematology Care Clinical Trials, LLC
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Oncology Associates of Oregon Willamette Valley Cancer Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Milton S Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19107-4216
      • Recruiting
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15232-1309
      • Recruiting
      • Upmc Hillman Cancer Center(Univ of Pittsburgh)
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Recruiting
      • Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga
    • Nashville, Tennessee, United States, 37205
      • Recruiting
      • Tennessee Oncology
  • Texas
    • Dallas, Texas, United States, 75246-2003
      • Recruiting
      • Texas Oncology Baylorcharles A Sammons Cancer Center
    • San Antonio, Texas, United States, 78240-5251
      • Recruiting
      • Texas Oncology San Antonio Medical Center Usor
    • Tyler, Texas, United States, 75702-7522
      • Recruiting
      • Texas Oncology Tyler
  • Washington
    • Vancouver, Washington, United States, 98684-6930
      • Recruiting
      • Northwest Cancer Specialist, Pc(Us Oncology Research)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Known active prolymphocytic leukemia or currently suspected Richter's transformation
• Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
• Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
• Known central nervous system involvement by CLL/SLL
• Severe or debilitating pulmonary disease
• Clinically significant cardiovascular disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Sonrotoclax plus Obinutuzumab; Sonrotoclax and obinutuzumab will be administered in combination.	Drug: Obinutuzumab; Administered intravenously; Other Names: Gazyva; Drug: Sonrotoclax; Administered orally; Other Names: BGB-11417
Experimental: Arm B: Sonrotoclax plus Rituximab; Sonrotoclax and rituximab will be administered in combination.	Drug: Rituximab; Administered intravenously; Other Names: Rituxan; Drug: Sonrotoclax; Administered orally; Other Names: BGB-11417
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).	Drug: Obinutuzumab; Administered intravenously; Other Names: Gazyva; Drug: Sonrotoclax; Administered orally; Other Names: BGB-11417
Active Comparator: Arm D: Venetoclax plus Rituximab; Venetoclax and rituximab will be administered in combination.	Drug: Rituximab; Administered intravenously; Other Names: Rituxan; Drug: Venetoclax; Administered Orally; Other Names: Venclexta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D	PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.	Up to approximately 51 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) as assessed by BIRC for Arm B versus Arm D	PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.	Up to approximately 69 months
Rate of uMRD4 for Arm A versus Arm D	The rate of undetectable minimal residual disease (uMRD4) in peripheral blood based on next-generation sequencing (NGS)	Up to approximately 12 months
Complete Response Rate as assessed by BIRC for Arm A versus Arm D	Complete Response Rate (CRR) is defined as the percentage of participants that achieve a best response of complete response (CR) or complete response with incomplete hematopoietic recovery (CRi)	Up to approximately 25 months
Overall Survival for Arm A versus Arm D	Overall survival (OS) is defined as the time from the date of randomization to the date of death	Up to approximately 84 months
PFS per Investigator Assessment (INV) for Arm B versus Arm D	PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.	Up to approximately 69 months
CRR per BIRC and by INV for Arm B versus Arm D	CRR is defined as the percentage of participants that achieve a best response of CR or CRi	Up to approximately 25 months
OS for Arm B versus Arm D	OS is defined as the time from the date of randomization to the date of death	Up to approximately 84 months
Rate of uMRD4 for Arm B versus Arm D	The rate of uMRD4 in peripheral blood based on NGS	Up to approximately 25 months
PFS per BIRC and by INV for Arm A versus Arm B	PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.	Up to approximately 69 months
CRR per BIRC and by INV for Arm A versus Arm B	CRR is defined as the percentage of participants that achieve a best response of CR or CRi	Up to approximately 25 months
OS for Arm A versus Arm B	OS is defined as the time from the date of randomization to the date of death	Up to approximately 84 months
Rate of uMRD4 for Arm A versus Arm B	The rate of uMRD4 in peripheral blood based on NGS	Up to approximately 25 months
Rate of uMRD4 for Arm A versus Arm D	The rate of uMRD4 in peripheral blood based on NGS	Up to approximately 25 months
CRR per INV for Arm A versus Arm D	CRR is defined as the percentage of participants that achieve a best response of CR or CRi	Up to approximately 25 months
PFS per INV for Arm A versus Arm D	PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.	Up to approximately 51 months
PFS per INV for Arm C versus Arm D	PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.	Up to approximately 69 months
CRR per INV for Arm C versus Arm D	CRR is defined as the percentage of participants that achieve a best response of CR or CRi	Up to approximately 25 months
OS for Arm C versus Arm D	OS is defined as the time from the date of randomization to the date of death	Up to approximately 84 months
Rate of uMRD4 for Arm C versus Arm D	The rate of uMRD4 in peripheral blood based on NGS	Up to approximately 25 months
Overall Response Rate (ORR) per BIRC and by INV	ORR is defined as the percentage of participants that achieve a best response of partial response (PR) or better	Up to approximately 25 months
Duration of Response (DOR) per BIRC and by INV	DOR is defined as the time from the date that response criteria were first met to the date of first documentation of disease progression or death, whichever occurs first	Up to approximately 69 months
Time to Response (TTR) per BIRC and by INV	TTR is defined as the time from the date of randomization to the date response criteria were first met	Up to approximately 25 months
Time to Next Anti-CLL/SLL Treatment (TTNT)	TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment	Up to approximately 84 months
Rate of uMRD4	The rate of uMRD4 in peripheral blood based on NGS	Up to approximately 25 months
Change from Baseline in the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Global Health Status/Quality of Life and Physical Functioning Scales	The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best). Higher scores in global health status (GHS) and functional scales indicate better health-related quality of life (HRQoL).	Baseline and up to approximately 69 months
Change from Baseline in EORTC QLQ for Chronic Lymphocytic Leukemia (EORTC QLQ-CLL17) Symptom Burden and Fatigue Scales	The EORTC QLQ-CLL17 is the CLL module of QLQ-C30 consisting of 17 items and comprising 3 scales: symptom burden due to disease and/or treatment (6 items), physical condition/fatigue (4 items), and worries/fears about health and functioning (7 items) Items are rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much") and the recall period for all items is the past 7 days. Lower scores indicate better HRQoL.	Baseline and up to approximately 69 months
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)	Number of participants with TEAEs, including laboratory values, vital signs, and physical examination findings, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.	From the first dose of study drug(s) to 30 days after the last dose of sonrotoclax or venetoclax, or 90 days after the last dose of obinutuzumab or rituximab; up to approximately 26 months

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Collaborators: German CLL Study Group
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: B-cell lymphoma 2 inhibitor (BCL-2i); CLL-RR1; German CLL Study Group
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Rituximab; venetoclax; obinutuzumab
• Other Study ID Numbers: BGB-11417-303; 2024-517131-52-00 (Ctis); CLL-RR1 (Other Identifier: German CLL Study Group)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No