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 in
participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.
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).
- 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.
- 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.