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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)
Trial Status: active
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.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06943872.
Locations matching your search criteria
United States
Connecticut
Fairfield
Smilow Cancer Hospital Care Center-Fairfield
Status: Active
Name Not Available
Greenwich
Smilow Cancer Hospital Care Center at Greenwich
Status: Active
Name Not Available
New Haven
Yale University
Status: Active
Name Not Available
North Haven
Yale-New Haven Hospital North Haven Medical Center