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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sonrotoclax, Obinutuzumab, Rituximab, Venetoclax.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +16
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Interventions
- Drug Sonrotoclax
Administered orally - Drug Obinutuzumab
Administered intravenously - Drug Rituximab
Administered intravenously - Drug Venetoclax
Administered Orally
Primary outcome measures
- Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) for Arm A versus Arm D [Time frame: Up to approximately 51 months]
Secondary outcome measures (12)
- Progression-Free Survival (PFS) as assessed by BIRC for Arm B versus Arm D [Time frame: Up to approximately 69 months]
- Rate of uMRD4 for Arm A versus Arm D [Time frame: Up to approximately 12 months]
- Complete Response Rate as assessed by BIRC for Arm A versus Arm D [Time frame: Up to approximately 25 months]
- Overall Survival for Arm A versus Arm D [Time frame: Up to approximately 84 months]
- PFS per Investigator Assessment (INV) for Arm B versus Arm D [Time frame: Up to approximately 69 months]
- CRR per BIRC and by INV for Arm B versus Arm D [Time frame: Up to approximately 25 months]
- OS for Arm B versus Arm D [Time frame: Up to approximately 84 months]
- Rate of uMRD4 for Arm B versus Arm D [Time frame: Up to approximately 25 months]
- PFS per BIRC and by INV for Arm A versus Arm B [Time frame: Up to approximately 69 months]
- CRR per BIRC and by INV for Arm A versus Arm B [Time frame: Up to approximately 25 months]
- OS for Arm A versus Arm B [Time frame: Up to approximately 84 months]
- Rate of uMRD4 for Arm A versus Arm B [Time frame: Up to approximately 25 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 38 centers
- Uci Health Laguna Hills — Laguna Hills
- Chao Family Comprehensive Cancer Center — Orange
- Stanford Cancer Institute — Palo Alto
- Scripps Prebys Cancer Center — San Diego
- Rocky Mountain Cancer Centers (Williams) Usor — Aurora
- Yale University Yale Cancer Center — New Haven
- Eastern Connecticut Hematology and Oncology — Norwich
- Cleveland Clinic Florida — Weston
- … and 30 more centers
China · 35 centers
Center list to be confirmed — check the primary protocol.
Brazil · 14 centers
- CETUS — Belo Horizonte
- Universidade de Campinas Centro de Hematologia E Hemoterapia — Campinas
- Hospital Erasto Gaertner — Curitiba
- Complexo Hospitalar de Niteroi — Niterói
- Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre — Porto Alegre
- Hospital Sao Lucas — Rio de Janeiro
- Instituto Dor de Pesquisa E Ensino Rio de Janeiro — Rio de Janeiro
- Hospital Santa Izabel — Salvador
- … and 6 more centers
Australia · 13 centers
- Blacktown Cancer and Haematology Centre — Blacktown
- St George Hospital — Kogarah
- Northern Nsw Health District — Lismore
- Macquarie University — North Ryde
- Genesiscare North Shore — St Leonards
- Sunshine Coast Hospital and Health Service — Birtinya
- Princess Alexandra Hospital — Woolloongabba
- Monash Health — Clayton
- … and 5 more centers
Germany · 11 centers
Center list to be confirmed — check the primary protocol.
Canada · 9 centers
- Arthur Je Child Comprehensive Cancer Centre — Calgary
- Cross Cancer Institute — Edmonton
- British Columbia Cancer Agency the Vancouver Centre — Vancouver
- Cancercare Manitoba — Winnipeg
- Newfoundland and Labrador Health Services — St. John's
- The Ottawa Hospital — Ottawa
- … and 3 more centers
France · 9 centers
Center list to be confirmed — check the primary protocol.
Spain · 9 centers
Center list to be confirmed — check the primary protocol.
Italy · 7 centers
Center list to be confirmed — check the primary protocol.
South Korea · 7 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 7 centers
Center list to be confirmed — check the primary protocol.
Czechia · 4 centers
Center list to be confirmed — check the primary protocol.
Denmark · 4 centers
Center list to be confirmed — check the primary protocol.
Ireland · 4 centers
Center list to be confirmed — check the primary protocol.
Netherlands · 4 centers
Center list to be confirmed — check the primary protocol.
Sweden · 4 centers
Center list to be confirmed — check the primary protocol.
Argentina · 3 centers
- Hospital Aleman — CABA
- FUNDALEU — Caba
- Instituto Alexander Fleming (Iaf) — Ciudad Autonoma Buenos Aires
Austria · 3 centers
- Medizinische Universitatsklinik Innsbruck — Innsbruck
- Medical University Vienna Oncology — Vienna
- Hanusch Krankenhaus — Vienna
Belgium · 3 centers
- Cliniques Universitaires Saint Luc — Brussels
- Uz Antwerpen — Edegem
- University Hospitals Leuven — Leuven
New Zealand · 2 centers
Center list to be confirmed — check the primary protocol.
Poland · 2 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06943872 · BGB-11417-303 · 2024-517131-52-00 · CLL-RR1