Actively Recruiting

Phase 3
Age: 18Years +
All Genders
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)

Led by BeOne Medicines · Updated on 2026-05-11

630

Participants Needed

170

Research Sites

337 weeks

Total Duration

On this page

Sponsors

B

BeOne Medicines

Lead Sponsor

G

German CLL Study Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of CLL or SLL meeting iwCLL criteria
  • Received one or more prior therapies for CLL/SLL, with at least 2 cycles per therapy
  • Prior BCL2 inhibitor exposure allowed if remission lasted 3 or more years and last BCL2 inhibitor taken at least 2 years ago
  • ECOG Performance Status of 0, 1, or 2
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • Known active prolymphocytic leukemia or suspected Richter's transformation
  • Prior autologous stem cell transplant or CAR T-cell therapy within 3 months before first study drug dose
  • Prior allogeneic stem cell transplant with active graft-versus-host disease or recent use of immunosuppressive drugs or calcineurin inhibitors
  • Known central nervous system involvement by CLL/SLL
  • Severe or debilitating lung disease
  • Significant cardiovascular disease
  • Other protocol-defined exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 170 locations

1

Uci Health Laguna Hills

Laguna Hills, California, United States, 92653

Actively Recruiting

2

Chao Family Comprehensive Cancer Center

Orange, California, United States, 92868-3201

Actively Recruiting

3

Stanford Cancer Institute

Palo Alto, California, United States, 94304-2205

Actively Recruiting

4

Scripps Prebys Cancer Center

San Diego, California, United States, 92103-2106

Actively Recruiting

5

Rocky Mountain Cancer Centers (Williams) Usor

Aurora, Colorado, United States, 80012-5405

Actively Recruiting

6

Yale University, Yale Cancer Center

New Haven, Connecticut, United States, 06520-8028

Actively Recruiting

7

Eastern Connecticut Hematology and Oncology

Norwich, Connecticut, United States, 06360-2700

Actively Recruiting

8

Cleveland Clinic Florida

Weston, Florida, United States, 33331-3609

Actively Recruiting

9

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

10

Illinois Cancer Specialists (Niles) Usor

Niles, Illinois, United States, 60714-5905

Actively Recruiting

11

University of Louisville, Brown Cancer Center

Louisville, Kentucky, United States, 40202

Actively Recruiting

12

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States, 70809-3738

Actively Recruiting

13

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201-1544

Actively Recruiting

14

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215-5418

Actively Recruiting

15

The Cancer and Hematology Centers

Grand Rapids, Michigan, United States, 49503-2563

Actively Recruiting

16

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905-0001

Actively Recruiting

17

Sidney Kimmel Comprehensive Cancer Center Washington Twp

Sewell, New Jersey, United States, 08080

Actively Recruiting

18

Christus St Vincent Regional Cancer Center

Santa Fe, New Mexico, United States, 87505

Actively Recruiting

19

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States, 10065-6800

Actively Recruiting

20

Clinical Research Alliance, Inc

Westbury, New York, United States, 11590-5119

Actively Recruiting

21

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States, 27514-4220

Actively Recruiting

22

Levine Cancer Center

Charlotte, North Carolina, United States, 28204-2990

Actively Recruiting

23

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

24

Oncology Hematology Care Clinical Trials, Llc

Cincinnati, Ohio, United States, 45245-1995

Actively Recruiting

25

Oncology Associates of Oregon Willamette Valley Cancer Center

Eugene, Oregon, United States, 97401

Actively Recruiting

26

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

27

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107-4216

Actively Recruiting

28

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Pittsburgh, Pennsylvania, United States, 15232-1309

Actively Recruiting

29

Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga

Chattanooga, Tennessee, United States, 37404

Actively Recruiting

30

Tennessee Oncology

Nashville, Tennessee, United States, 37205

Actively Recruiting

31

Texas Oncology Baylorcharles A Sammons Cancer Center

Dallas, Texas, United States, 75246-2003

Actively Recruiting

32

Texas Oncology San Antonio Medical Center Usor

San Antonio, Texas, United States, 78240-5251

Actively Recruiting

33

Texas Oncology Tyler

Tyler, Texas, United States, 75702-7522

Actively Recruiting

34

Northwest Cancer Specialist, Pc(Us Oncology Research)

Vancouver, Washington, United States, 98684-6930

Actively Recruiting

35

FUNDALEU

Caba, Argentina, CP1114

Actively Recruiting

36

Instituto Alexander Fleming (Iaf)

Ciudad Autonoma Buenos Aires, Argentina, 1426

Actively Recruiting

37

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia, NSW 2148

Actively Recruiting

38

St George Hospital

Kogarah, New South Wales, Australia, NSW 2217

Actively Recruiting

39

Northern Nsw Health District

Lismore, New South Wales, Australia, NSW 2480

Actively Recruiting

40

Macquarie University

North Ryde, New South Wales, Australia, NSW 2109

Actively Recruiting

41

Genesiscare North Shore

St Leonards, New South Wales, Australia, NSW 2065

Actively Recruiting

42

Sunshine Coast Hospital and Health Service

Birtinya, Queensland, Australia, QLD 4575

Actively Recruiting

43

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, QLD 4102

Actively Recruiting

44

Monash Health

Clayton, Victoria, Australia, VIC 3168

Actively Recruiting

45

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia, VIC 3065

Actively Recruiting

46

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia, VIC 3000

Actively Recruiting

47

The Alfred Hospital

Melbourne, Victoria, Australia, VIC 3004

Actively Recruiting

48

Rockingham Hospital

Cooloongup, Western Australia, Australia, WA 6168

Actively Recruiting

49

Perth Blood Institute

West Perth, Western Australia, Australia, WA 6005

Actively Recruiting

50

Medizinische Universitatsklinik Innsbruck

Innsbruck, Austria, 6020

Actively Recruiting

51

Medical University Vienna Oncology

Vienna, Austria, 1090

Actively Recruiting

52

Hanusch Krankenhaus

Vienna, Austria, 1140

Actively Recruiting

53

Cliniques Universitaires Saint Luc

Brussels, Belgium, 1200

Actively Recruiting

54

Uz Antwerpen

Edegem, Belgium, 2650

Actively Recruiting

55

University Hospitals Leuven

Leuven, Belgium, 3000

Actively Recruiting

56

CETUS

Belo Horizonte, Brazil, 30110-022

Active, Not Recruiting

57

Universidade de Campinas Centro de Hematologia E Hemoterapia

Campinas, Brazil, 13083-878

Active, Not Recruiting

58

Hospital Erasto Gaertner

Curitiba, Brazil, 81520-060

Active, Not Recruiting

59

Complexo Hospitalar de Niteroi

Niterói, Brazil, 24020-096

Active, Not Recruiting

60

Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre

Porto Alegre, Brazil, 90020-090

Active, Not Recruiting

61

Hospital Sao Lucas

Rio de Janeiro, Brazil, 22061-080

Active, Not Recruiting

62

Instituto Dor de Pesquisa E Ensino Rio de Janeiro

Rio de Janeiro, Brazil, 22281-100

Active, Not Recruiting

63

Hospital Santa Izabel

Salvador, Brazil, 40050-410

Active, Not Recruiting

64

Hospital Samaritano Sao Paulo

São Paulo, Brazil, 01232-010

Active, Not Recruiting

65

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil, 01401-004

Active, Not Recruiting

66

Hospital Nove de Julho Dasa

São Paulo, Brazil, 01409-001

Active, Not Recruiting

67

Instituto Brasileiro de Controle Do Cancer

São Paulo, Brazil, 04014-002

Active, Not Recruiting

68

Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular

São Paulo, Brazil, 05402-000

Active, Not Recruiting

69

Hospital Santa Rita de Cassia Afecc

Vitória, Brazil, 29043-260

Active, Not Recruiting

70

Arthur Je Child Comprehensive Cancer Centre

Calgary, Alberta, Canada, T2N 5G2

Actively Recruiting

71

British Columbia Cancer Agency the Vancouver Centre

Vancouver, British Columbia, Canada, V5Z 4E6

Actively Recruiting

72

Newfoundland and Labrador Health Services

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Actively Recruiting

73

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

74

Ciusss Nim Hscm

Montreal, Quebec, Canada, H4J 1C5

Actively Recruiting

75

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

Québec, Canada, G1J 1Z4

Actively Recruiting

76

China Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100029

Actively Recruiting

77

Fujian Provincial Hospital

Fuzhou, Fujian, China, 350001

Actively Recruiting

78

Fujian Medical University Union Hospitalqishan Branch

Fuzhou, Fujian, China, 350108

Actively Recruiting

79

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China, 361003

Actively Recruiting

80

Guangzhou First Peoples Hospital

Guangzhou, Guangdong, China, 510013

Actively Recruiting

81

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China, 510515

Actively Recruiting

82

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi, China, 530201

Actively Recruiting

83

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050000

Actively Recruiting

84

Xiangya Hospital of Central South University

Changsha, Hunan, China, 410008

Actively Recruiting

85

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China, 010050

Actively Recruiting

86

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China, 210009

Actively Recruiting

87

Suzhou Municipal Hospitalbaita Branch

Suzhou, Jiangsu, China, 215001

Actively Recruiting

88

Affiliated Hospital of Jiangnan University South Campus

Wuxi, Jiangsu, China, 214122

Actively Recruiting

89

Northern Jiangsu Peoples Hospital

Yangzhou, Jiangsu, China, 225001

Actively Recruiting

90

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China, 330029

Actively Recruiting

91

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China, 110042

Actively Recruiting

92

Shaanxi Provincial Peoples Hospital

Xi'an, Shaanxi, China, 710068

Actively Recruiting

93

Shandong Provincial Hospital

Jinan, Shandong, China, 250021

Actively Recruiting

94

Jining No1 Peoples Hospital West Branch

Jining, Shandong, China, 272000

Actively Recruiting

95

The Affiliated Hospital of Qingdao University Branch West Coast

Qingdao, Shandong, China, 266555

Actively Recruiting

96

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

97

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

98

The Affiliated Peoples Hospital of Ningbo University

Ningbo, Zhejiang, China, 315040

Actively Recruiting

99

Taizhou Hospital of Zhejiang Province (East)

Taizhou, Zhejiang, China, 317004

Actively Recruiting

100

Fakultni Nemocnice Brno

Brno, Czechia, 625 00

Actively Recruiting

101

Fakultni Nemocnice Hradec Kralove

Hradec Králové, Czechia, 500 03

Actively Recruiting

102

Vseobecna Fakultni Nemocnice V Praze

Prague, Czechia, 10000

Actively Recruiting

103

Ustav Hematologie A Krevni Transfuze (Uhkt)

Prague, Czechia, 128 00

Actively Recruiting

104

University Hospital of Aalborg

Aalborg, Denmark, 9000

Actively Recruiting

105

Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

106

Odense University Hospital

Odense C, Denmark, 5000

Actively Recruiting

107

Zealand University Hospital, Roskilde

Roskilde, Denmark, 4000

Actively Recruiting

108

Chu Clermont Ferrand Therapie Cellulaire and Hematolo

Clermontferrand, France, 63100

Actively Recruiting

109

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, France, 44000

Actively Recruiting

110

Hopital de La Pitie Salpetriere

Paris, France, 75013

Actively Recruiting

111

Chu Hopital Lyon Sud

PierreBenite, France, 69495

Actively Recruiting

112

Hopital Robert Debre

Reims, France, 51100

Actively Recruiting

113

Chu Rennes

Rennes Cedes, France, 35000

Actively Recruiting

114

Centre Henri Becquerel

Rouen, France, 76038

Actively Recruiting

115

Iuct Oncopole

Toulouse, France, 31100

Actively Recruiting

116

Chu Nancy Hopital Brabois

VandoeuvrelesNancy, France, 54511

Actively Recruiting

117

Osp Kurfuerstendamm

Berlin, Germany, 10707

Actively Recruiting

118

Uniklinik Koeln (Aoer)

Cologne, Germany, 50937

Actively Recruiting

119

Gokos Gmbh

Dresden, Germany, 01307

Actively Recruiting

120

Universitatsklinikum Jena Klinik Fur Innere Medizin Ii

Jena, Germany, 07747

Actively Recruiting

121

Universitatsklinikum Schleswig Holstein, Campus Kiel

Kiel, Germany, 24105

Actively Recruiting

122

Stauferklinikum Schwabisch Gmund Kliniken Ostalb

Mutlangen, Germany, 73557

Actively Recruiting

123

Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii

München, Germany, 81377

Actively Recruiting

124

Dietrich Bonhoeffer Klinikum Neubrandenburg

Neubrandenburg, Germany, 17036

Actively Recruiting

125

Medizinische Universitaetsklinik

Tübingen, Germany, 72076

Actively Recruiting

126

Universitaetsklinikum Ulm

Ulm, Germany, 89081

Actively Recruiting

127

Haematologisch Onkologische Schwerpunktpraxis

Würzburg, Germany, 97080

Actively Recruiting

128

St Jamess Hospital

Dublin, Ireland, D08 NHY1

Actively Recruiting

129

Mater Misericordiae University Hospital

Dublin, Ireland, D7

Actively Recruiting

130

University Hospital Galway

Galway, Ireland, H91 YR71

Actively Recruiting

131

University Hospital Limerick

Limerick, Ireland, V94F858

Actively Recruiting

132

Azienda Ospedaliera Policlinico Di Bari

Bari, Italy, 70124

Actively Recruiting

133

Ao Brotzu Ospedale Oncologico Armando Businco

Cagliari, Italy, 09121

Actively Recruiting

134

Po Grodolico, Aou Policlinico Vittorio Emanuele Di Catania

Catania, Italy, 95123

Actively Recruiting

135

Azienda Ospedaliero Universitaria Di Ferrara

Ferrara, Italy, 44124

Actively Recruiting

136

Ospedale San Raffaele

Milan, Italy, 20132

Actively Recruiting

137

Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

Modena, Italy, 41124

Actively Recruiting

138

Asl Salerno Andrea Tortora

Pagani, Italy, 84014

Actively Recruiting

139

Flevoziekenhuis

Almere Stad, Netherlands, 1315 RA

Actively Recruiting

140

Rijnstate

Arnhem, Netherlands, 6815 AD

Actively Recruiting

141

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands, 3318 AT

Actively Recruiting

142

Tergooi Mc

Hilversum, Netherlands, 1212 VG

Actively Recruiting

143

North Shore Hospital

Auckland, New Zealand, 0622

Actively Recruiting

144

Auckland City Hospital

Auckland, New Zealand, 1023

Actively Recruiting

145

Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu

Torun, Poland, 87-100

Actively Recruiting

146

Pusan National University Hospital

Seogu, Busan Gwang'yeogsi, South Korea, 49241

Actively Recruiting

147

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do, South Korea, 10408

Actively Recruiting

148

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

149

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea, 06351

Actively Recruiting

150

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea, 06591

Actively Recruiting

151

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722

Actively Recruiting

152

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea, 03080

Actively Recruiting

153

Vall D Hebron Institute of Oncology Vhio

Barcelona, Spain, 08035

Actively Recruiting

154

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Actively Recruiting

155

Ico Lhospitalet Hospital Duran I Reynals

Lhospitalet de Llobregat, Spain, 08908

Actively Recruiting

156

Hospital de La Princesa

Madrid, Spain, 28006

Actively Recruiting

157

Hospital Universitario Infanta Leonor

Madrid, Spain, 28031

Actively Recruiting

158

Costa Del Sol (Marbella, Malaga)

Marbella, Spain, 29603

Actively Recruiting

159

Hospital Universitario de Salamanca

Salamanca, Spain, 37007

Actively Recruiting

160

Hospital Universitario Marques de Valdecilla

Santander, Spain, 39008

Actively Recruiting

161

Hospital Virgen de Valme (Sevilla)

Seville, Spain, 41014

Actively Recruiting

162

Sahlgrenska University Hospital Hematology

Gothenburg, Sweden, 413 46

Actively Recruiting

163

Skanes Universitetssjukhus I Lund

Lund, Sweden, 221 85

Actively Recruiting

164

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden, 171 76

Actively Recruiting

165

Uppsala Akademiska Sjukhus

Uppsala, Sweden, 751 85

Actively Recruiting

166

University Hospitals Dorset Royal Bournemouth Hospital

Bournemouth, United Kingdom, BH7 7DW

Actively Recruiting

167

Kings College Hospital

London, United Kingdom, SE5 9RS

Actively Recruiting

168

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, United Kingdom, CH63 4JY

Actively Recruiting

169

Freeman Hospital

Newcastle upon Tyne, United Kingdom, NE7 7DN

Actively Recruiting

170

Royal Cornwall Hospitalsnhs Trust

Truro, United Kingdom, TR1 3LJ

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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