RecruitingPhase 3NCT06943872

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

Sponsor

BeOne Medicines

Enrollment

630 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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

Interventions

DRUGSonrotoclax

Administered orally

DRUGObinutuzumab

Administered intravenously

DRUGRituximab

Administered intravenously

DRUGVenetoclax

Administered Orally

Locations(155)

Uci Health Laguna Hills

Laguna Hills, California, United States

Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

Scripps Prebys Cancer Center

San Diego, California, United States

Rocky Mountain Cancer Centers (Williams) Usor

Aurora, Colorado, United States

Yale University, Yale Cancer Center

New Haven, Connecticut, United States

Eastern Connecticut Hematology and Oncology

Norwich, Connecticut, United States

Northwestern University

Chicago, Illinois, United States

Illinois Cancer Specialists (Niles) Usor

Niles, Illinois, United States

University of Louisville, Brown Cancer Center

Louisville, Kentucky, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

The Cancer and Hematology Centers

Grand Rapids, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Sidney Kimmel Comprehensive Cancer Center Washington Twp

Sewell, New Jersey, United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States

Clinical Research Alliance, Inc

Westbury, New York, United States

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States

Levine Cancer Center

Charlotte, North Carolina, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Oncology Hematology Care Clinical Trials, Llc

Cincinnati, Ohio, United States

Oncology Associates of Oregon Willamette Valley Cancer Center

Eugene, Oregon, United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Pittsburgh, Pennsylvania, United States

Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga

Chattanooga, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology Baylorcharles A Sammons Cancer Center

Dallas, Texas, United States

Texas Oncology San Antonio Medical Center Usor

San Antonio, Texas, United States

Texas Oncology Tyler

Tyler, Texas, United States

Northwest Cancer Specialist, Pc(Us Oncology Research)

Vancouver, Washington, United States

FUNDALEU

Caba, Argentina

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Northern Nsw Health District

Lismore, New South Wales, Australia

Macquarie University

North Ryde, New South Wales, Australia

Genesiscare North Shore

St Leonards, New South Wales, Australia

Sunshine Coast Hospital and Health Service

Birtinya, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Monash Health

Clayton, Victoria, Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Rockingham Hospital

Cooloongup, Western Australia, Australia

Perth Blood Institute

West Perth, Western Australia, Australia

Medizinische Universitatsklinik Innsbruck

Innsbruck, Austria

Medical University Vienna Oncology

Vienna, Austria

Hanusch Krankenhaus

Vienna, Austria

Cliniques Universitaires Saint Luc

Brussels, Belgium

Uz Antwerpen

Edegem, Belgium

University Hospitals Leuven

Leuven, Belgium

CETUS

Belo Horizonte, Brazil

Universidade de Campinas Centro de Hematologia E Hemoterapia

Campinas, Brazil

Hospital Erasto Gaertner

Curitiba, Brazil

Complexo Hospitalar de Niteroi

Niterói, Brazil

Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre

Porto Alegre, Brazil

Hospital Sao Lucas

Rio de Janeiro, Brazil

Instituto Dor de Pesquisa E Ensino Rio de Janeiro

Rio de Janeiro, Brazil

Hospital Santa Izabel

Salvador, Brazil

Hospital Samaritano Sao Paulo

São Paulo, Brazil

Hospital Nove de Julho Dasa

São Paulo, Brazil

Instituto Brasileiro de Controle Do Cancer

São Paulo, Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil

Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

São Paulo, Brazil

Hospital Santa Rita de Cassia Afecc

Vitória, Brazil

Arthur Je Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

China Japan Friendship Hospital

Beijing, Beijing Municipality, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

Fujian Medical University Union Hospitalqishan Branch

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Guangzhou First Peoples Hospital

Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Suzhou Municipal Hospitalbaita Branch

Suzhou, Jiangsu, China

Affiliated Hospital of Jiangnan University South Campus

Wuxi, Jiangsu, China

Northern Jiangsu Peoples Hospital

Yangzhou, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Shaanxi Provincial Peoples Hospital

Xi'an, Shaanxi, China

Shandong Provincial Hospital

Jinan, Shandong, China

Jining No1 Peoples Hospital West Branch

Jining, Shandong, China

The Affiliated Hospital of Qingdao University Branch West Coast

Qingdao, Shandong, China

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

The Affiliated Peoples Hospital of Ningbo University

Ningbo, Zhejiang, China

Taizhou Hospital of Zhejiang Province (East)

Taizhou, Zhejiang, China

Fakultni Nemocnice Brno

Brno, Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, Czechia

University Hospital of Aalborg

Aalborg, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense C, Denmark

Zealand University Hospital, Roskilde

Roskilde, Denmark

Chu Clermont Ferrand Therapie Cellulaire and Hematolo

Clermontferrand, France

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, France

Hopital de La Pitie Salpetriere

Paris, France

Chu Hopital Lyon Sud

PierreBenite, France

Hopital Robert Debre

Reims, France

Chu Rennes

Rennes Cedes, France

Centre Henri Becquerel

Rouen, France

Iuct Oncopole

Toulouse, France

Chu Nancy Hopital Brabois

VandoeuvrelesNancy, France

Osp Kurfuerstendamm

Berlin, Germany

Uniklinik Koeln (Aoer)

Cologne, Germany

Gokos Gmbh

Dresden, Germany

Universitatsklinikum Jena Klinik Fur Innere Medizin Ii

Jena, Germany

Stauferklinikum Schwabisch Gmund Kliniken Ostalb

Mutlangen, Germany

Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii

München, Germany

Dietrich Bonhoeffer Klinikum Neubrandenburg

Neubrandenburg, Germany

Medizinische Universitaetsklinik

Tübingen, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Haematologisch Onkologische Schwerpunktpraxis

Würzburg, Germany

St Jamess Hospital

Dublin, Ireland

Mater Misericordiae University Hospital

Dublin, Ireland

University Hospital Galway

Galway, Ireland

University Hospital Limerick

Limerick, Ireland

Ao Brotzu Ospedale Oncologico Armando Businco

Cagliari, Italy

Ospedale San Raffaele

Milan, Italy

Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

Modena, Italy

Asl Salerno Andrea Tortora

Pagani, Italy

Flevoziekenhuis

Almere Stad, Netherlands

Rijnstate

Arnhem, Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Tergooi Mc

Hilversum, Netherlands

North Shore Hospital

Auckland, New Zealand

Auckland City Hospital

Auckland, New Zealand

Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu

Torun, Poland

Pusan National University Hospital

Seogu, Busan Gwang'yeogsi, South Korea

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Vall D Hebron Institute of Oncology Vhio

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Ico Lhospitalet Hospital Duran I Reynals

Lhospitalet de Llobregat, Spain

Hospital de La Princesa

Madrid, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Costa Del Sol (Marbella, Malaga)

Marbella, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Hospital Virgen de Valme (Sevilla)

Seville, Spain

Sahlgrenska University Hospital Hematology

Gothenburg, Sweden

Skanes Universitetssjukhus I Lund

Lund, Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden

Uppsala Akademiska Sjukhus

Uppsala, Sweden

University Hospitals Dorset Royal Bournemouth Hospital

Bournemouth, United Kingdom

Kings College Hospital

London, United Kingdom

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Royal Cornwall Hospitalsnhs Trust

Truro, United Kingdom

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