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A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
Trial Status: active
This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax
(BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R
WM) and in combination with zanubrutinib in adult participants with previously untreated
WM.
Inclusion Criteria
Clinical and definitive histologic diagnosis of WM.
Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM).
For Cohorts 1-3, refractory or relapsed disease at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy.
For Cohort 4, patients must not have received prior therapy for WM (except for plasmapheresis).
Adequate organ function.
Exclusion Criteria
Central nervous system (CNS) involvement by WM.
Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.
History of other malignancies ≤ 2 years before study entry.
Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Additional locations may be listed on ClinicalTrials.gov for NCT05952037.