Chronic Lymphocytic LeukemiaPhase 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 study testing Sonrotoclax, Obinutuzumab and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by BeOne Medicines at 195 sites in 21 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Sonrotoclax, Obinutuzumab and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 195 sitesin 21 countries
- Study dates
- 11 Jun 2025to Dec 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
195 sites in 21 countries. Contact the study team or a site near you to ask about taking part.
195 sites in 21 countries
United States39 sites, 39 recruiting
- Recruiting
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, 80012-5405
- Recruiting
The University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
- Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809-3738
- Recruiting
Beth Israel Deaconess Medical Center (Bidmc)
Boston, Massachusetts, 02215-5400
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418
- Recruiting
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27514-4220
- Recruiting
Levine Cancer Center
Charlotte, North Carolina, 28204-2990
- Recruiting
Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga
Chattanooga, Tennessee, 37404
- Recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
Oncology Hematology Care Clinical Trials, Llc
Cincinnati, Ohio, 45245-1995
- Recruiting
Texas Oncology Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246-2003
- Recruiting
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, 97401
- Recruiting
The Cancer and Hematology Centers
Grand Rapids, Michigan, 49503-2563
- Recruiting
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009
- Recruiting
Uci Health Laguna Hills
Laguna Hills, California, 92653
- Recruiting
University of Louisville, Brown Cancer Center
Louisville, Kentucky, 40202
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37205
- Recruiting
Yale University Yale Cancer Center
New Haven, Connecticut, 06520-8028
- Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800
- Recruiting
Illinois Cancer Specialists (Niles) Usor
Niles, Illinois, 60714-5905
- Recruiting
Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, 06360-2700
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
Chao Family Comprehensive Cancer Center
Orange, California, 92868-3201
- Recruiting
Stanford Cancer Institute
Palo Alto, California, 94304-2205
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-4216
- Recruiting
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, 15232-1309
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905-0001
- Recruiting
Texas Oncology San Antonio Medical Center Usor
San Antonio, Texas, 78240-5251
- Recruiting
Scripps Prebys Cancer Center
San Diego, California, 92103-2106
- Recruiting
Christus St Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505
- Recruiting
Swedish Medical Center Swedish Cancer Institute First Hill Campus
Seattle, Washington, 98104
- Recruiting
Sidney Kimmel Comprehensive Cancer Center Washington Twp
Sewell, New Jersey, 08080
- Recruiting
Texas Oncology Tyler
Tyler, Texas, 75702-7522
- Recruiting
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, 98684-6930
- Recruiting
Mission Cancer and Blood
Waukee, Iowa, 50263
- Recruiting
Optum Medical Care, Pc
Westbury, New York, 11590-5119
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331-3609
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
China35 sites, 35 recruiting
- Recruiting
China Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 630014
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
- Recruiting
Fujian Medical University Union Hospitalqishan Branch
Fuzhou, Fujian, 350108
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
- Recruiting
Guangzhou First Peoples Hospital
Guangzhou, Guangdong, 510013
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicinegrand Canal Branch
Hangzhou, Zhejiang, 310000
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010050
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250000
- Recruiting
Jining No1 Peoples Hospital West Branch
Jining, Shandong, 272000
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
- Recruiting
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi, 530201
- Recruiting
The Affiliated Peoples Hospital of Ningbo University
Ningbo, Zhejiang, 315040
- Recruiting
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, Shandong, 266555
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
- Recruiting
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
- Recruiting
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
- Recruiting
Taihe Hospital
Shiyan, Hubei, 442000
- Recruiting
Suzhou Municipal Hospitalbaita Branch
Suzhou, Jiangsu, 215001
- Recruiting
Taizhou Hospital of Zhejiang Province (East)
Taizhou, Zhejiang, 317004
- Recruiting
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, 301617
- Recruiting
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030
- Recruiting
Affiliated Hospital of Jiangnan University South Campus
Wuxi, Jiangsu, 214122
- Recruiting
Shaanxi Provincial Peoples Hospital
Xi'an, Shaanxi, 710068
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
- Recruiting
Northern Jiangsu Peoples Hospital
Yangzhou, Jiangsu, 225001
Brazil14 sites
- Active, not recruiting
CETUS
Belo Horizonte, 30110-022
- Active, not recruiting
Universidade de Campinas Centro de Hematologia E Hemoterapia
Campinas, 13083-878
- Active, not recruiting
Hospital Erasto Gaertner
Curitiba, 81520-060
- Active, not recruiting
Complexo Hospitalar de Niteroi
Niterói, 24020-096
- Active, not recruiting
Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre
Porto Alegre, 90020-090
- Active, not recruiting
Hospital Sao Lucas
Rio de Janeiro, 22061-080
- Active, not recruiting
Instituto Dor de Pesquisa E Ensino Rio de Janeiro
Rio de Janeiro, 22281-100
- Active, not recruiting
Hospital Santa Izabel
Salvador, 40050-410
- Active, not recruiting
Hospital Samaritano Sao Paulo
São Paulo, 01232-010
- Active, not recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, 01401-004
- Active, not recruiting
Hospital Nove de Julho Dasa
São Paulo, 01409-001
- Active, not recruiting
Instituto Brasileiro de Controle Do Cancer
São Paulo, 04014-002
- Active, not recruiting
Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
São Paulo, 05403-010
- Active, not recruiting
Hospital Santa Rita de Cassia Afecc
Vitória, 29043-260
Australia13 sites, 13 recruiting
- Recruiting
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, QLD 4575
- Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148
- Recruiting
Monash Health
Clayton, Victoria, VIC 3168
- Recruiting
Rockingham Hospital
Cooloongup, Western Australia, WA 6168
- Recruiting
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065
- Recruiting
St George Hospital
Kogarah, New South Wales, NSW 2217
- Recruiting
Northern Nsw Health District
Lismore, New South Wales, NSW 2480
- Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria, VIC 3000
- Recruiting
The Alfred Hospital
Melbourne, Victoria, VIC 3004
- Recruiting
Macquarie University
North Ryde, New South Wales, NSW 2109
- Recruiting
Genesiscare North Shore
St Leonards, New South Wales, NSW 2065
- Recruiting
Perth Blood Institute
West Perth, Western Australia, WA 6005
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102
Germany11 sites, 11 recruiting
- Recruiting
Osp Kurfuerstendamm
Berlin, 10707
- Recruiting
Uniklinik Koeln (Aoer)
Cologne, 50937
- Recruiting
Gokos Gmbh
Dresden, 01307
- Recruiting
Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
Jena, 07747
- Recruiting
Universitatsklinikum Schleswig Holstein Campus Kiel
Kiel, 24105
- Recruiting
Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii
München, 81377
- Recruiting
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
Mutlangen, 73557
- Recruiting
Dietrich Bonhoeffer Klinikum Neubrandenburg
Neubrandenburg, 17036
- Recruiting
Medizinische Universitaetsklinik
Tübingen, 72076
- Recruiting
Universitaetsklinikum Ulm
Ulm, 89081
- Recruiting
Haematologisch Onkologische Schwerpunktpraxis
Würzburg, 97080
Canada9 sites, 9 recruiting
- Recruiting
Arthur Je Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
- Recruiting
Ciusss Nim Hscm
Montreal, Quebec, H4J 1C5
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
- Recruiting
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, G1J 1Z4
- Recruiting
Newfoundland and Labrador Health Services
St. John's, Newfoundland and Labrador, A1B 3V6
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
- Recruiting
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
- Recruiting
Cancercare Manitoba
Winnipeg, Manitoba, R3E 0V9
France9 sites, 9 recruiting
- Recruiting
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
ClermontFerrand, 63100
- Recruiting
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, 44000
- Recruiting
Hopital de La Pitie Salpetriere
Paris, 75013
- Recruiting
Chu Hopital Lyon Sud
PierreBenite, 69495
- Recruiting
Hopital Robert Debre
Reims, 51100
- Recruiting
Chu Rennes
Rennes Cedes, 35000
- Recruiting
Centre Henri Becquerel
Rouen, 76038
- Recruiting
Iuct Oncopole
Toulouse, 31100
- Recruiting
Chu Nancy Hopital Brabois
VandoeuvrelesNancy, 54511
Spain9 sites, 9 recruiting
- Recruiting
Vall D Hebron Institute of Oncology Vhio
Barcelona, 08035
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Ico Lhospitalet Hospital Duran I Reynals
LHospitalet de Llobregat, 08908
- Recruiting
Hospital de La Princesa
Madrid, 28006
- Recruiting
Hospital Universitario Infanta Leonor
Madrid, 28031
- Recruiting
Costa Del Sol (Marbella, Malaga)
Marbella, 29603
- Recruiting
Hospital Universitario de Salamanca
Salamanca, 37007
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, 39008
- Recruiting
Hospital Virgen de Valme (Sevilla)
Seville, 41014
Italy8 sites, 8 recruiting
- Recruiting
Azienda Ospedaliera Policlinico Di Bari
Bari, 70124
- Recruiting
Ao Brotzu Ospedale Oncologico Armando Businco
Cagliari, 09121
- Recruiting
Po Grodolico, Aou Policlinico Vittorio Emanuele Di Catania
Catania, 95123
- Recruiting
Azienda Ospedaliero Universitaria Di Ferrara
Ferrara, 44124
- Recruiting
Ospedale San Raffaele
Milan, 20132
- Recruiting
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
- Recruiting
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
Modena, 41124
- Recruiting
Asl Salerno Andrea Tortora
Pagani, 84014
South Korea7 sites, 7 recruiting
- Recruiting
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351
- Recruiting
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, 10408
- Recruiting
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591
- Recruiting
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722
- Recruiting
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, 49241
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
United Kingdom7 sites, 7 recruiting
- Recruiting
University Hospitals Dorset Royal Bournemouth Hospital
Bournemouth, BH7 7DW
- Recruiting
Oxford University Hospitals Nhs Trust Churchill Hospital
Headington, OX3 7LE
- Recruiting
St Jamess University Hospital
Leeds, LS9 7TF
- Recruiting
Kings College Hospital
London, SE5 9RS
- Recruiting
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY
- Recruiting
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
- Recruiting
Royal Cornwall Hospitalsnhs Trust
Truro, TR1 3LJ
Czechia4 sites, 4 recruiting
- Recruiting
Fakultni Nemocnice Brno
Brno, 625 00
- Recruiting
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 03
- Recruiting
Vseobecna Fakultni Nemocnice V Praze
Prague, 10000
- Recruiting
Ustav Hematologie A Krevni Transfuze (Uhkt)
Prague, 128 00
Denmark4 sites, 4 recruiting
- Recruiting
University Hospital of Aalborg
Aalborg, 9000
- Recruiting
Rigshospitalet
Copenhagen, 2100
- Recruiting
Zealand University Hospital
Køge, 4600
- Recruiting
Odense University Hospital
Odense, 5000
Ireland4 sites, 4 recruiting
- Recruiting
St Jamess Hospital
Dublin, D08 NHY1
- Recruiting
Mater Misericordiae University Hospital
Dublin, D7
- Recruiting
University Hospital Galway
Galway, H91 YR71
- Recruiting
University Hospital Limerick
Limerick, V94F858
Netherlands4 sites, 4 recruiting
- Recruiting
Flevoziekenhuis
Almere Stad, 1315 RA
- Recruiting
Rijnstate
Arnhem, 6815 AD
- Recruiting
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT
- Recruiting
Tergooi Mc
Hilversum, 1212 VG
Sweden4 sites, 4 recruiting
- Recruiting
Sahlgrenska University Hospital Hematology
Gothenburg, 413 46
- Recruiting
Skanes Universitetssjukhus I Lund
Lund, 221 85
- Recruiting
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76
- Recruiting
Uppsala Akademiska Sjukhus
Uppsala, 751 85
Argentina3 sites, 3 recruiting
- Recruiting
Hospital Aleman
Caba, 1425
- Recruiting
FUNDALEU
Caba, CP1114
- Recruiting
Instituto Alexander Fleming (Iaf)
Ciudad Autonoma Buenos Aires, 1426
Austria3 sites, 3 recruiting
- Recruiting
Medizinische Universitatsklinik Innsbruck
Innsbruck, 6020
- Recruiting
Medical University Vienna Oncology
Vienna, 1090
- Recruiting
Hanusch Krankenhaus
Vienna, 1140
Belgium3 sites, 3 recruiting
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, 1200
- Recruiting
Uz Antwerpen
Edegem, 2650
- Recruiting
University Hospitals Leuven
Leuven, 3000
Poland3 sites, 3 recruiting
- Recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, 93-510
- Recruiting
Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
Torun, 87-100
- Recruiting
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, 50-367
New Zealand2 sites, 2 recruiting
- Recruiting
North Shore Hospital
Auckland, 0622
- Recruiting
Auckland City Hospital
Auckland, 1023
About this study
Official title: 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.
Read the 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.
- Being tested
- Sonrotoclax, Obinutuzumab, Rituximab, Venetoclax
- Keywords
- B-cell lymphoma 2 inhibitor (BCL-2i), CLL-RR1, German CLL Study Group
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonrotoclaxDrug
Also called BGB-11417
Administered orally
ObinutuzumabDrug
Also called Gazyva
Administered intravenously
RituximabDrug
Also called Rituxan
Administered intravenously
VenetoclaxDrug
Also called Venclexta
Administered Orally
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Sonrotoclax plus Obinutuzumab | Experimental | Sonrotoclax and obinutuzumab will be administered in combination. Receives: Drug: Sonrotoclax; Drug: Obinutuzumab |
| Arm B: Sonrotoclax plus Rituximab | Experimental | Sonrotoclax and rituximab will be administered in combination. Receives: Drug: Sonrotoclax; Drug: Rituximab |
| Arm C: Sonrotoclax plus Obinutuzumab (MRD) | Experimental | Sonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD). Receives: Drug: Sonrotoclax; Drug: Obinutuzumab |
| Arm D: Venetoclax plus Rituximab | Active comparator | Venetoclax and rituximab will be administered in combination. Receives: Drug: Rituximab; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 51 months
Secondary outcomes (27)
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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to approximately 84 months
Rate of uMRD4 for Arm B versus Arm D
The rate of uMRD4 in peripheral blood based on NGS
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to approximately 84 months
Rate of uMRD4 for Arm A versus Arm B
The rate of uMRD4 in peripheral blood based on NGS
Measured: Up to approximately 25 months
Rate of uMRD4 for Arm A versus Arm D
The rate of uMRD4 in peripheral blood based on NGS
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to approximately 84 months
Rate of uMRD4 for Arm C versus Arm D
The rate of uMRD4 in peripheral blood based on NGS
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to approximately 84 months
Rate of uMRD4
The rate of uMRD4 in peripheral blood based on NGS
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start11 Jun 2025
- Primary completion30 Sep 2029 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- German CLL Study Group
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943872
- Sponsor's protocol ID
- BGB-11417-303
- Other IDs
- 2024-517131-52-00, CLL-RR1
- Status last verified
- Mar 2026
- First submitted
- 17 Apr 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.