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
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- BeOne Medicines
- Enrolment target
- 630
- Started
- 11 June 2025
- Main results due
- 30 September 2029
- Study sites
- 195
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(195)
Uci Health Laguna Hills
Laguna Hills, California, United States
Recruiting
Chao Family Comprehensive Cancer Center
Orange, California, United States
Recruiting
Stanford Cancer Institute
Palo Alto, California, United States
Recruiting
Scripps Prebys Cancer Center
San Diego, California, United States
Recruiting
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, United States
Recruiting
Yale University Yale Cancer Center
New Haven, Connecticut, United States
Recruiting
Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, United States
Recruiting
Cleveland Clinic Florida
Weston, Florida, United States
Recruiting
Northwestern University
Chicago, Illinois, United States
Recruiting
Illinois Cancer Specialists (Niles) Usor
Niles, Illinois, United States
Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Recruiting
Mission Cancer and Blood
Waukee, Iowa, United States
Recruiting
University of Louisville, Brown Cancer Center
Louisville, Kentucky, United States
Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Recruiting
The University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Recruiting
Beth Israel Deaconess Medical Center (Bidmc)
Boston, Massachusetts, United States
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
The Cancer and Hematology Centers
Grand Rapids, Michigan, United States
Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, United States
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, United States
Recruiting
Sidney Kimmel Comprehensive Cancer Center Washington Twp
Sewell, New Jersey, United States
Recruiting
Christus St Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Recruiting
Optum Medical Care, Pc
Westbury, New York, United States
Recruiting
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Recruiting
Levine Cancer Center
Charlotte, North Carolina, United States
Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Recruiting
Oncology Hematology Care Clinical Trials, Llc
Cincinnati, Ohio, United States
Recruiting
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, United States
Recruiting
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Recruiting
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, United States
Recruiting
Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga
Chattanooga, Tennessee, United States
Recruiting
Tennessee Oncology
Nashville, Tennessee, United States
Recruiting
Texas Oncology Baylorcharles A Sammons Cancer Center
Dallas, Texas, United States
Recruiting
Texas Oncology San Antonio Medical Center Usor
San Antonio, Texas, United States
Recruiting
Texas Oncology Tyler
Tyler, Texas, United States
Recruiting
Swedish Medical Center Swedish Cancer Institute First Hill Campus
Seattle, Washington, United States
Recruiting
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, United States
Recruiting
Hospital Aleman
Caba, Argentina
Recruiting
FUNDALEU
Caba, Argentina
Recruiting
Instituto Alexander Fleming (Iaf)
Ciudad Autonoma Buenos Aires, Argentina
Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Recruiting
St George Hospital
Kogarah, New South Wales, Australia
Recruiting
Northern Nsw Health District
Lismore, New South Wales, Australia
Recruiting
Macquarie University
North Ryde, New South Wales, Australia
Recruiting
Genesiscare North Shore
St Leonards, New South Wales, Australia
Recruiting
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, Australia
Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Recruiting
Monash Health
Clayton, Victoria, Australia
Recruiting
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Recruiting
The Alfred Hospital
Melbourne, Victoria, Australia
Recruiting
Rockingham Hospital
Cooloongup, Western Australia, Australia
Recruiting
Perth Blood Institute
West Perth, Western Australia, Australia
Recruiting
Medizinische Universitatsklinik Innsbruck
Innsbruck, Austria
Recruiting
Medical University Vienna Oncology
Vienna, Austria
Recruiting
Hanusch Krankenhaus
Vienna, Austria
Recruiting
Cliniques Universitaires Saint Luc
Brussels, Belgium
Recruiting
Uz Antwerpen
Edegem, Belgium
Recruiting
Showing 60 of 195 sites — filter to narrow it down. 181 of the 195 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06943872. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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