A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Partic… (NCT06637501) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia
United States94 participantsStarted 2024-11-14
Plain-language summary
The purpose of this study is to support the registration plan of sonrotoclax plus zanubrutinib treatment in participants with previously untreated chronic lymphocytic leukemia (CLL). This study is designed to assess the contribution of sonrotoclax to the efficacy outcome of the combination of zanubrutinib and sonrotoclax.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Previously untreated adult patient ≥ 18 years with a confirmed diagnosis of CLL.
✓. CLL requiring treatment as per pre-defined criteria.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0,1, or 2.
✓. Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI).
✓. Adequate marrow function.
✓. Adequate liver function as indicated by aspartate aminotransferase (AST) alanine aminotransferase (ALT) and serum total bilirubin.
✓. Adequate renal function.
✓. Life expectancy \> 6 months.
Exclusion criteria
✕. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation