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)
NCT ID: NCT06943872
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
630 participants
INTERVENTIONAL
2025-06-11
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Sonrotoclax plus Obinutuzumab
Sonrotoclax and obinutuzumab will be administered in combination.
Sonrotoclax
Administered orally
Obinutuzumab
Administered intravenously
Arm B: Sonrotoclax plus Rituximab
Sonrotoclax and rituximab will be administered in combination.
Sonrotoclax
Administered orally
Rituximab
Administered intravenously
Arm C: Sonrotoclax plus Obinutuzumab (MRD)
Sonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD).
Sonrotoclax
Administered orally
Obinutuzumab
Administered intravenously
Arm D: Venetoclax plus Rituximab
Venetoclax and rituximab will be administered in combination.
Rituximab
Administered intravenously
Venetoclax
Administered Orally
Interventions
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Sonrotoclax
Administered orally
Obinutuzumab
Administered intravenously
Rituximab
Administered intravenously
Venetoclax
Administered Orally
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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German CLL Study Group
OTHER
BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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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
Illinois Cancer Specialists (Niles) Usor
Niles, Illinois, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
The Cancer and Hematology Centers
Grand Rapids, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, 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
Oncology Hematology Care Clinical Trials, Llc
Cincinnati, Ohio, United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, 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
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
Hanusch Krankenhaus
Vienna, , Austria
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
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
Osp Kurfuerstendamm
Berlin, , Germany
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
Mutlangen, , Germany
North Shore Hospital
Auckland, , New Zealand
Auckland City Hospital
Auckland, , New Zealand
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, South Korea
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do, South Korea
National Cancer Center (Korea)
IlsandongGu GoyangSi, 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
Countries
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Central Contacts
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Other Identifiers
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2024-517131-52-00
Identifier Type: CTIS
Identifier Source: secondary_id
CLL-RR1
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-11417-303
Identifier Type: -
Identifier Source: org_study_id