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.
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
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
Parallel
Sonrotoclax
DrugAdministered orally
Obinutuzumab
DrugAdministered intravenously
Rituximab
DrugAdministered intravenously
Venetoclax
DrugAdministered Orally
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.
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.
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)
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)
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
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BeOne Medicines
Lead sponsor
German CLL Study Group
Collaborator