An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB-11417 in Patients With Relapsed/Refractory Waldenström’s Macroglobulinemia
Trial Description
This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417
(sonrotoclax) in participants with relapsed/refractory Waldenström's Macroglobulinemia
(R/R WM) and in combination with zanubrutinib in adult participants with previously
untreated WM.
Eligibility Requirements
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 to the most recent therapy 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.
- 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.