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)

PHASE3RecruitingINTERVENTIONAL
Enrollment

630

Participants

Timeline

Start Date

June 11, 2025

Primary Completion Date

September 30, 2029

Study Completion Date

December 31, 2032

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Sonrotoclax

Administered orally

DRUG

Obinutuzumab

Administered intravenously

DRUG

Rituximab

Administered intravenously

DRUG

Venetoclax

Administered Orally

Trial Locations (178)

1023

RECRUITING

Auckland City Hospital, Auckland

1090

NOT_YET_RECRUITING

Medical University Vienna Oncology, Vienna

1140

NOT_YET_RECRUITING

Hanusch Krankenhaus, Vienna

1200

NOT_YET_RECRUITING

Cliniques Universitaires Saint Luc, Brussels

1425

NOT_YET_RECRUITING

Hospital Aleman, CABA

1426

NOT_YET_RECRUITING

Instituto Alexander Fleming (Iaf), Ciudad Autonoma Buenos Aires

2100

NOT_YET_RECRUITING

Rigshospitalet, Copenhagen

2650

NOT_YET_RECRUITING

Uz Antwerpen, Edegem

3000

NOT_YET_RECRUITING

University Hospitals Leuven, Leuven

4000

NOT_YET_RECRUITING

Zealand University Hospital, Roskilde, Roskilde

5000

NOT_YET_RECRUITING

Odense University Hospital, Odense C

6020

NOT_YET_RECRUITING

Medizinische Universitatsklinik Innsbruck, Innsbruck

8036

NOT_YET_RECRUITING

Hospital Clinic de Barcelona, Barcelona

9000

NOT_YET_RECRUITING

University Hospital of Aalborg, Denmark, Aalborg

10000

NOT_YET_RECRUITING

Vseobecna Fakultni Nemocnice V Praze, Prague

10408

RECRUITING

National Cancer Center (Korea), IlsandongGu GoyangSi

10707

NOT_YET_RECRUITING

Osp Kurfuerstendamm, Berlin

13620

RECRUITING

Seoul National University Bundang Hospital, BundangGu SeongnamSi

17033

NOT_YET_RECRUITING

Penn State Milton S Hershey Medical Center, Hershey

17036

NOT_YET_RECRUITING

Dietrich Bonhoeffer Klinikum Neubrandenburg, Neubrandenburg

20132

NOT_YET_RECRUITING

Ospedale San Raffaele, Milan

20162

NOT_YET_RECRUITING

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

24105

NOT_YET_RECRUITING

Universitatsklinikum Schleswig Holstein, Campus Kiel, Kiel

28006

NOT_YET_RECRUITING

Hospital de La Princesa, Madrid

28031

NOT_YET_RECRUITING

Hospital Universitario Infanta Leonor, Madrid

29603

NOT_YET_RECRUITING

Costa Del Sol (Marbella, Malaga), Marbella

31100

NOT_YET_RECRUITING

Iuct Oncopole, Toulouse

35000

NOT_YET_RECRUITING

Chu Rennes, Rennes Cedes

37007

NOT_YET_RECRUITING

Hospital Universitario de Salamanca, Salamanca

37205

RECRUITING

Tennessee Oncology, Nashville

39008

NOT_YET_RECRUITING

Hospital Universitario Marques de Valdecilla, Santander

40202

NOT_YET_RECRUITING

University of Louisville, Brown Cancer Center, Louisville

41014

NOT_YET_RECRUITING

Hospital Virgen de Valme (Sevilla), Seville

41124

NOT_YET_RECRUITING

Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco, Modena

44000

NOT_YET_RECRUITING

Centre Hospitalier Universitaire Nantes Hotel Dieu, Nantes

44124

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Di Ferrara, Ferrara

49241

RECRUITING

Pusan National University Hospital, Seogu

50263

NOT_YET_RECRUITING

Mission Cancer and Blood, Waukee

50937

NOT_YET_RECRUITING

Uniklinik Koeln (Aoer), Cologne

51100

NOT_YET_RECRUITING

Hopital Robert Debre, Reims

54511

NOT_YET_RECRUITING

Chu Nancy Hopital Brabois, VandoeuvrelesNancy

60611

NOT_YET_RECRUITING

Northwestern University, Chicago

63100

NOT_YET_RECRUITING

Chu Clermont Ferrand Therapie Cellulaire and Hematolo, Clermontferrand

69495

NOT_YET_RECRUITING

Chu Hopital Lyon Sud, PierreBenite

70124

NOT_YET_RECRUITING

Azienda Ospedaliera Policlinico Di Bari, Bari

72076

NOT_YET_RECRUITING

Medizinische Universitaetsklinik, Tübingen

73557

NOT_YET_RECRUITING

Stauferklinikum Schwabisch Gmund Kliniken Ostalb, Mutlangen

75013

NOT_YET_RECRUITING

Hopital de La Pitie Salpetriere, Paris

76038

NOT_YET_RECRUITING

Centre Henri Becquerel, Rouen

81377

NOT_YET_RECRUITING

Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii, München

84014

NOT_YET_RECRUITING

Asl Salerno Andrea Tortora, Pagani

89081

NOT_YET_RECRUITING

Universitaetsklinikum Ulm, Ulm

95123

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania

97080

NOT_YET_RECRUITING

Haematologisch Onkologische Schwerpunktpraxis, Würzburg

97401

RECRUITING

Oncology Associates of Oregon Willamette Valley Cancer Center, Eugene

100029

NOT_YET_RECRUITING

China Japan Friendship Hospital, Beijing

110042

NOT_YET_RECRUITING

Liaoning Cancer Hospital and Institute, Shenyang

200032

NOT_YET_RECRUITING

Affiliated Zhongshan Hospital of Fudan University, Shanghai

210009

NOT_YET_RECRUITING

Zhongda Hospital Southeast University, Nanjing

214122

NOT_YET_RECRUITING

Affiliated Hospital of Jiangnan University South Campus, Wuxi

215001

NOT_YET_RECRUITING

Suzhou Municipal Hospitalbaita Branch, Suzhou

225001

NOT_YET_RECRUITING

Northern Jiangsu Peoples Hospital, Yangzhou

250021

NOT_YET_RECRUITING

Shandong Provincial Hospital, Jinan

266555

NOT_YET_RECRUITING

The Affiliated Hospital of Qingdao University Branch West Coast, Qingdao

272000

NOT_YET_RECRUITING

Jining No Peoples Hospital West Branch, Jining

301617

NOT_YET_RECRUITING

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

315040

NOT_YET_RECRUITING

The Affiliated Peoples Hospital of Ningbo University, Ningbo

317004

NOT_YET_RECRUITING

Taizhou Hospital of Zhejiang Province (East), Taizhou

330029

NOT_YET_RECRUITING

Jiangxi Cancer Hospital, Nanchang

350001

NOT_YET_RECRUITING

Fujian Provincial Hospital, Fuzhou

350108

NOT_YET_RECRUITING

Fujian Medical University Union Hospitalqishan Branch, Fuzhou

361003

NOT_YET_RECRUITING

The First Affiliated Hospital of Xiamen University, Xiamen

410008

NOT_YET_RECRUITING

Xiangya Hospital of Central South University, Changsha

510013

NOT_YET_RECRUITING

Guangzhou First Peoples Hospital, Guangzhou

510515

NOT_YET_RECRUITING

Nanfang Hospital, Southern Medical University, Guangzhou

530201

NOT_YET_RECRUITING

Guangxi Medical University Cancer Hospital Wuxiang Branch, Nanning

610041

NOT_YET_RECRUITING

West China Hospital, Sichuan University, Chengdu

710068

NOT_YET_RECRUITING

Shaanxi Provincial Peoples Hospital, Xi'an

92868-3201

NOT_YET_RECRUITING

Chao Family Comprehensive Cancer Center, Orange

94304-2205

RECRUITING

Stanford Cancer Institute, Palo Alto

92103-2106

NOT_YET_RECRUITING

Scripps Prebys Cancer Center, San Diego

80012-5405

RECRUITING

Rocky Mountain Cancer Centers (Williams) Usor, Aurora

06520-8028

NOT_YET_RECRUITING

Yale University, Yale Cancer Center, New Haven

06360-2700

RECRUITING

Eastern Connecticut Hematology and Oncology, Norwich

33331-3609

NOT_YET_RECRUITING

Cleveland Clinic Florida, Weston

60714-5905

NOT_YET_RECRUITING

Illinois Cancer Specialists (Niles) Usor, Niles

70809-3738

RECRUITING

Mary Bird Perkins Cancer Center, Baton Rouge

21201-1544

NOT_YET_RECRUITING

University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore

02215-5418

NOT_YET_RECRUITING

Dana Farber Cancer Institute, Boston

49503-2563

NOT_YET_RECRUITING

The Cancer and Hematology Centers, Grand Rapids

55905-0001

NOT_YET_RECRUITING

Mayo Clinic Rochester, Rochester

10065-6800

NOT_YET_RECRUITING

Memorial Sloan Kettering Cancer Center Mskcc, New York

11590-5119

RECRUITING

Clinical Research Alliance, Inc, Westbury

27514-4220

NOT_YET_RECRUITING

University of North Carolina At Chapel Hill, Chapel Hill

28204-2990

RECRUITING

Levine Cancer Center, Charlotte

45245-1995

NOT_YET_RECRUITING

Oncology Hematology Care Clinical Trials, Llc, Cincinnati

19107-4216

NOT_YET_RECRUITING

Thomas Jefferson University, Philadelphia

15232-1309

NOT_YET_RECRUITING

Upmc Hillman Cancer Center(Univ of Pittsburgh), Pittsburgh

75246-2003

NOT_YET_RECRUITING

Texas Oncology Baylorcharles A Sammons Cancer Center, Dallas

75390-7208

NOT_YET_RECRUITING

Ut Southwestern Medical Center, Dallas

78240-5251

RECRUITING

Texas Oncology San Antonio Medical Center Usor, San Antonio

75702-7522

NOT_YET_RECRUITING

Texas Oncology Tyler, Tyler

98684-6930

RECRUITING

Northwest Cancer Specialist, Pc(Us Oncology Research), Vancouver

CP1114

NOT_YET_RECRUITING

FUNDALEU, Caba

NSW 2148

RECRUITING

Blacktown Cancer and Haematology Centre, Blacktown

NSW 2217

RECRUITING

St George Hospital, Kogarah

NSW 2480

RECRUITING

Northern Nsw Health District, Lismore

NSW 2109

RECRUITING

Macquarie University, North Ryde

NSW 2065

RECRUITING

Genesiscare North Shore, St Leonards

QLD 4575

RECRUITING

Sunshine Coast Hospital and Health Service, Birtinya

QLD 4102

RECRUITING

Princess Alexandra Hospital, Woolloongabba

VIC 3168

RECRUITING

Monash Health, Clayton

VIC 3065

RECRUITING

St Vincents Hospital Melbourne, Fitzroy

VIC 3000

RECRUITING

Peter Maccallum Cancer Centre, Melbourne

VIC 3004

RECRUITING

The Alfred Hospital, Melbourne

WA 6168

RECRUITING

Rockingham Hospital, Cooloongup

WA 6005

NOT_YET_RECRUITING

Perth Blood Institute, West Perth

30110-022

RECRUITING

CETUS, Belo Horizonte

13083-878

NOT_YET_RECRUITING

Universidade de Campinas Centro de Hematologia E Hemoterapia, Campinas

81520-060

RECRUITING

Hospital Erasto Gaertner, Curitiba

24020-096

NOT_YET_RECRUITING

Complexo Hospitalar de Niteroi, Niterói

90020-090

RECRUITING

Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre, Porto Alegre

22061-080

NOT_YET_RECRUITING

Hospital Sao Lucas, Rio de Janeiro

22281-100

RECRUITING

Instituto Dor de Pesquisa E Ensino Rio de Janeiro, Rio de Janeiro

40050-410

RECRUITING

Hospital Santa Izabel, Salvador

01232-010

RECRUITING

Hospital Samaritano Sao Paulo, São Paulo

01409-001

NOT_YET_RECRUITING

Hospital Nove de Julho Dasa, São Paulo

04014-002

RECRUITING

Instituto Brasileiro de Controle Do Cancer, São Paulo

04501-000

RECRUITING

Instituto Dor de Pesquisa E Ensino Sao Paulo, São Paulo

05402-000

RECRUITING

Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular, São Paulo

29043-260

RECRUITING

Hospital Santa Rita de Cassia Afecc, Vitória

T6G 1Z2

NOT_YET_RECRUITING

Cross Cancer Institute, Edmonton

V5Z 4E6

NOT_YET_RECRUITING

British Columbia Cancer Agency the Vancouver Centre, Vancouver

R3E 0V9

NOT_YET_RECRUITING

Cancercare Manitoba, Winnipeg

A1B 3V6

NOT_YET_RECRUITING

Newfoundland and Labrador Health Services, St. John's

K1H 8L6

NOT_YET_RECRUITING

The Ottawa Hospital, Ottawa

M5G 2M9

NOT_YET_RECRUITING

Princess Margaret Cancer Centre, Toronto

H4J 1C5

NOT_YET_RECRUITING

Ciusss Nim Hscm, Montreal

T2N 5G2

NOT_YET_RECRUITING

Arthur Je Child Comprehensive Cancer Centre, Calgary

G1J 1Z4

NOT_YET_RECRUITING

Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic), Québec

010050

NOT_YET_RECRUITING

The Affiliated Hospital of Inner Mongolia Medical University, Hohhot

625 00

NOT_YET_RECRUITING

Fakultni Nemocnice Brno, Brno

500 03

NOT_YET_RECRUITING

Fakultni Nemocnice Hradec Kralove, Hradec Králové

128 00

NOT_YET_RECRUITING

Ustav Hematologie A Krevni Transfuze (Uhkt), Prague

01307

NOT_YET_RECRUITING

Gokos Gmbh, Dresden

07747

NOT_YET_RECRUITING

Universitatsklinikum Jena Klinik Fur Innere Medizin Ii, Jena

D7

NOT_YET_RECRUITING

Mater Misericordiae University Hospital, Dublin

D8

NOT_YET_RECRUITING

St Jamess Hospital, Dublin

H91 YR71

NOT_YET_RECRUITING

University Hospital Galway, Galway

V94F858

NOT_YET_RECRUITING

University Hospital Limerick, Limerick

09121

NOT_YET_RECRUITING

Ao Brotzu Ospedale Oncologico Armando Businco, Cagliari

1315 RA

NOT_YET_RECRUITING

Flevoziekenhuis, Almere Stad

6815 AD

NOT_YET_RECRUITING

Rijnstate, Arnhem

3318 AT

NOT_YET_RECRUITING

Albert Schweitzer Ziekenhuis, Dordrecht

1212 VG

NOT_YET_RECRUITING

Tergooi Mc, Hilversum

0622

RECRUITING

North Shore Hospital, Auckland

80-214

NOT_YET_RECRUITING

Uniwersyteckie Centrum Kliniczne, Gdansk

93-513

NOT_YET_RECRUITING

Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi, Lodz

87-100

NOT_YET_RECRUITING

Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu, Torun

02-097

NOT_YET_RECRUITING

Centralny Szpital Kliniczny Uck Wum, Warsaw

50-367

NOT_YET_RECRUITING

Uniwersytecki Szpital Kliniczny Hematology, Wroclaw

06351

RECRUITING

Samsung Medical Center, GangnamGu

06591

RECRUITING

The Catholic University of Korea, Seoul St Marys Hospital, SeochoGu

03722

RECRUITING

Severance Hospital Yonsei University Health System, SeodaemunGu

03080

RECRUITING

Seoul National University Hospital, Seoul

08035

NOT_YET_RECRUITING

Vall D Hebron Institute of Oncology Vhio, Barcelona

08908

NOT_YET_RECRUITING

Ico Lhospitalet Hospital Duran I Reynals, Lhospitalet de Llobregat

413 46

NOT_YET_RECRUITING

Sahlgrenska University Hospital Hematology, Gothenburg

221 85

NOT_YET_RECRUITING

Skanes Universitetssjukhus I Lund, Lund

171 76

NOT_YET_RECRUITING

Karolinska Universitetssjukhuset Solna, Stockholm

751 85

NOT_YET_RECRUITING

Uppsala Akademiska Sjukhus, Uppsala

BH7 7DW

NOT_YET_RECRUITING

University Hospitals Dorset Royal Bournemouth Hospital, Bournemouth

OX3 7LE

NOT_YET_RECRUITING

Churchill Hospital Oxford University Hospital Nhs Trust, Headington

LS9 7TF

NOT_YET_RECRUITING

St Jamess University Hospital, Leeds

SE5 9RS

NOT_YET_RECRUITING

Kings College Hospital, London

CH63 4JY

NOT_YET_RECRUITING

Clatterbridge Cancer Centre, Metropolitan Borough of Wirral

NE7 7DN

NOT_YET_RECRUITING

Freeman Hospital, Newcastle upon Tyne

TR1 3LJ

NOT_YET_RECRUITING

Royal Cornwall Hospitalsnhs Trust, Truro

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

German CLL Study Group

OTHER

lead

BeiGene

INDUSTRY

NCT06943872 - 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) | Biotech Hunter | Biotech Hunter