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)

Last updated: July 10, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

3

Condition

Leukemia

Leukemia (Pediatric)

Platelet Disorders

Treatment

Obinutuzumab

Sonrotoclax

Venetoclax

Clinical Study ID

NCT06943872
BGB-11417-303
CLL-RR1
2024-517131-52-00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of CLL/SLL that meets the International Workshop on ChronicLymphocytic 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 ≥3years with ≥2 years from last BCL2i intake

  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2

  • Adequate organ function

Exclusion

Exclusion Criteria:

  • Known active prolymphocytic leukemia or currently suspected Richter's transformation

  • Prior autologous stem cell transplantation or chimeric antigen receptor T-celltherapy 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 calcineurininhibitors 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 Design

Total Participants: 630
Treatment Group(s): 4
Primary Treatment: Obinutuzumab
Phase: 3
Study Start date:
June 11, 2025
Estimated Completion Date:
December 31, 2032

Connect with a study center

  • FUNDALEU

    Caba, CP1114
    Argentina

    Site Not Available

  • Hospital Aleman

    Caba, 1425
    Argentina

    Site Not Available

  • Instituto Alexander Fleming (Iaf)

    Ciudad Autonoma Buenos Aires, 1426
    Argentina

    Site Not Available

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • St George Hospital

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Northern Nsw Health District

    Lismore, New South Wales 2480
    Australia

    Site Not Available

  • Macquarie University

    North Ryde, New South Wales 2109
    Australia

    Site Not Available

  • Genesiscare North Shore

    St Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Wollongong Private Hospital

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • Sunshine Coast Hospital and Health Service

    Birtinya, Queensland 4575
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Rockingham Hospital

    Cooloongup, Western Australia 6168
    Australia

    Site Not Available

  • Perth Blood Institute

    West Perth, Western Australia 6005
    Australia

    Site Not Available

  • Landeskrankenhaus Universitaetskliniken Innsbruck

    Innsbruck, 6020
    Austria

    Site Not Available

  • Hanusch Krankenhaus

    Wien, 1140
    Austria

    Site Not Available

  • Medical University Vienna Oncology

    Wien, 1090
    Austria

    Site Not Available

  • Cliniques Universitaires Saint Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Uz Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • University Hospitals Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • CETUS

    Belo Horizonte, 30110-022
    Brazil

    Site Not Available

  • Universidade de Campinas Centro de Hematologia E Hemoterapia

    Campinas, 13083-878
    Brazil

    Site Not Available

  • Hospital Erasto Gaertner

    Curitiba, 81520-060
    Brazil

    Site Not Available

  • Complexo Hospitalar de Niteroi

    Niteroi, 24020-096
    Brazil

    Site Not Available

  • Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre

    Porto Alegre, 90020-090
    Brazil

    Site Not Available

  • Hospital Sao Lucas

    Rio de Janeiro, 22061-080
    Brazil

    Site Not Available

  • Instituto Dor de Pesquisa E Ensino Rio de Janeiro

    Rio de Janeiro, 22281-100
    Brazil

    Site Not Available

  • Hospital Santa Izabel

    Salvador, 40050-410
    Brazil

    Site Not Available

  • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

    Sao Paulo, 05402-000
    Brazil

    Active - Recruiting

  • Hospital Nove de Julho Dasa

    Sao Paulo, 01409-001
    Brazil

    Site Not Available

  • Hospital Samaritano Sao Paulo

    Sao Paulo, 01232-010
    Brazil

    Site Not Available

  • Instituto Brasileiro de Controle Do Cancer

    Sao Paulo, 04014-002
    Brazil

    Site Not Available

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    Sao Paulo, 04501-000
    Brazil

    Active - Recruiting

  • Hospital Santa Rita de Cassia Afecc

    Vitoria, 29043-260
    Brazil

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • British Columbia Cancer Agency the Vancouver Centre

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Cancercare Manitoba

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • Newfoundland and Labrador Health Services

    St Johns, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Ciusss Nim Hscm

    Montreal, Quebec H4J 1C5
    Canada

    Site Not Available

  • Arthur Je Child Comprehensive Cancer Centre

    Calgary, T2N 5G2
    Canada

    Site Not Available

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

    Tianjin, Tianjin 301617
    China

    Site Not Available

  • Fakultni Nemocnice Brno

    Brno, 625 00
    Czechia

    Site Not Available

  • Fakultni Nemocnice Hradec Kralove

    Hradec Kralove, 500 03
    Czechia

    Site Not Available

  • Ustav Hematologie A Krevni Transfuze (Uhkt)

    Praha, 128 00
    Czechia

    Site Not Available

  • Vseobecna Fakultni Nemocnice V Praze

    Praha, 10000
    Czechia

    Site Not Available

  • University Hospital of Aalborg, Denmark

    Aalborg, 9000
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense C, 5000
    Denmark

    Site Not Available

  • Zealand University Hospital, Roskilde

    Roskilde, 4000
    Denmark

    Site Not Available

  • Chu Clermont Ferrand Therapie Cellulaire and Hematolo

    Clermontferrand, 63100
    France

    Site Not Available

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes, 44000
    France

    Site Not Available

  • Hopital de La Pitie Salpetriere

    Paris, 75013
    France

    Site Not Available

  • Chu Hopital Lyon Sud

    PierreBenite, 69495
    France

    Site Not Available

  • Hopital Robert Debre

    Reims, 51100
    France

    Site Not Available

  • Chu Rennes

    Rennes Cedes, 35000
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen Cedex, 76038
    France

    Site Not Available

  • Icans Institut de Cancerologie Strasbourg Europe

    Strasbourg, 67200
    France

    Site Not Available

  • Iuct Oncopole

    Toulouse, 31100
    France

    Site Not Available

  • Chu Nancy Hopital Brabois

    VandoeuvrelesNancy, 54511
    France

    Site Not Available

  • Osp Kurfuerstendamm

    Berlin, 10707
    Germany

    Site Not Available

  • Gokos Gmbh

    Dresden, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Jena Klinik Fur Innere Medizin Ii

    Jena, 07747
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig Holstein, Campus Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Uniklinik Koeln (Aoer)

    Koln, 50937
    Germany

    Site Not Available

  • Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii

    Munchen, 81377
    Germany

    Site Not Available

  • Stauferklinikum Schwabisch Gmund Kliniken Ostalb

    Mutlangen, 73557
    Germany

    Site Not Available

  • Dietrich Bonhoeffer Klinikum Neubrandenburg

    Neubrandenburg, 17036
    Germany

    Site Not Available

  • Medizinische Universitaetsklinik

    Tubingen, 72076
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Haematologisch Onkologische Schwerpunktpraxis

    Wurzburg, 97080
    Germany

    Site Not Available

  • Mater Misericordiae University Hospital

    Dublin, D7
    Ireland

    Site Not Available

  • St Jamess Hospital

    Dublin, D8
    Ireland

    Site Not Available

  • University Hospital Galway

    Galway, H91 YR71
    Ireland

    Site Not Available

  • University Hospital Limerick

    Limerick, V94F858
    Ireland

    Site Not Available

  • Azienda Ospedaliera Policlinico Di Bari

    Bari, 70124
    Italy

    Site Not Available

  • Ao Brotzu Ospedale Oncologico Armando Businco

    Cagliari, 09121
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, 95123
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Di Ferrara

    Ferrara, 44124
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

    Modena, 41124
    Italy

    Site Not Available

  • Asl Salerno Andrea Tortora

    Pagani, 84014
    Italy

    Site Not Available

  • Pusan National University Hospital

    SeoGu, Busan Gwang'yeogsi 49241
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    BundangGu SeongnamSi, Gyeonggi-do 13620
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center (Korea)

    IlsandongGu GoyangSi, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Active - Recruiting

  • Flevoziekenhuis

    Almere, 1315 RA
    Netherlands

    Site Not Available

  • Rijnstate

    Arnhem, 6815 AD
    Netherlands

    Site Not Available

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT
    Netherlands

    Site Not Available

  • Tergooi Mc

    Hilversum, 1212 VG
    Netherlands

    Site Not Available

  • Auckland City Hospital

    Auckland, 1023
    New Zealand

    Site Not Available

  • North Shore Hospital

    Auckland, 0622
    New Zealand

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdask, 80-214
    Poland

    Site Not Available

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    OD, 93-513
    Poland

    Site Not Available

  • Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu

    Torun, 87-100
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny Uck Wum

    Warszawa, 02-097
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Hematology

    Wrocaw, 50-367
    Poland

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 8036
    Spain

    Site Not Available

  • Vall D Hebron Institute of Oncology Vhio

    Barcelona, 08035
    Spain

    Site Not Available

  • Ico Lhospitalet Hospital Duran I Reynals

    Lhospitalet de Llobregat, 08908
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor

    Madrid, 28031
    Spain

    Site Not Available

  • Hospital de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Costa Del Sol (Marbella, Malaga)

    Marbella, 29603
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Hospital Virgen de Valme (Sevilla)

    Sevilla, 41014
    Spain

    Site Not Available

  • Sahlgrenska University Hospital Hematology

    Goteborg, 413 46
    Sweden

    Site Not Available

  • Skanes Universitetssjukhus I Lund

    Lund, 221 85
    Sweden

    Site Not Available

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76
    Sweden

    Site Not Available

  • Uppsala Akademiska Sjukhus

    Uppsala, 751 85
    Sweden

    Site Not Available

  • University Hospitals Dorset Royal Bournemouth Hospital

    Bournemouth, BH7 7DW
    United Kingdom

    Site Not Available

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington, OX3 7LE
    United Kingdom

    Site Not Available

  • St Jamess University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Freeman Hospital

    NewCastle Upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Clatterbridge Cancer Centre

    Wirral, CH63 4JY
    United Kingdom

    Site Not Available

  • Chao Family Comprehensive Cancer Center

    Orange, California 92868-3201
    United States

    Site Not Available

  • Stanford Cancer Institute

    Palo Alto, California 94304-2205
    United States

    Site Not Available

  • Scripps Prebys Cancer Center

    San Diego, California 92103-2106
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers (Williams) Usor

    Aurora, Colorado 80012-5405
    United States

    Site Not Available

  • Yale University, Yale Cancer Center

    New Haven, Connecticut 06520-8028
    United States

    Site Not Available

  • Eastern Connecticut Hematology and Oncology

    Norwich, Connecticut 06360-2700
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136-2107
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331-3609
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Illinois Cancer Specialists (Niles) Usor

    Niles, Illinois 60714-5905
    United States

    Site Not Available

  • Mission Cancer and Blood

    Waukee, Iowa 50263
    United States

    Site Not Available

  • University of Louisville, Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana 70809-3738
    United States

    Site Not Available

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland 21201-1544
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215-5418
    United States

    Site Not Available

  • The Cancer and Hematology Centers

    Grand Rapids, Michigan 49503-2563
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905-0001
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York 10065-6800
    United States

    Site Not Available

  • Clinical Research Alliance, Inc

    Westbury, New York 11590-5119
    United States

    Active - Recruiting

  • University of North Carolina At Chapel Hill

    Chapel Hill, North Carolina 27514-4220
    United States

    Site Not Available

  • Levine Cancer Center

    Charlotte, North Carolina 28204-2990
    United States

    Site Not Available

  • Oncology Hematology Care Clinical Trials, Llc

    Cincinnati, Ohio 45245-1995
    United States

    Site Not Available

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Upmc Hillman Cancer Center(Univ of Pittsburgh)

    Pittsburgh, Pennsylvania 15232-1309
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Texas Oncology Baylorcharles A Sammons Cancer Center

    Dallas, Texas 75246-2003
    United States

    Site Not Available

  • Ut Southwestern Medical Center

    Dallas, Texas 75390-7208
    United States

    Site Not Available

  • Texas Oncology San Antonio Medical Center Usor

    San Antonio, Texas 78240-5251
    United States

    Site Not Available

  • Texas Oncology Tyler

    Tyler, Texas 75702-7522
    United States

    Site Not Available

  • Northwest Cancer Specialist, Pc(Us Oncology Research)

    Vancouver, Washington 98684-6930
    United States

    Site Not Available

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