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

This is an open-label study, which means that the participants, study doctor, and the research team know that the participants are receiving study medication and know participants are receiving which doses of study medication. This is a multicentre and Phase 2 study of BGB-11417.This study will look at the safety and effectiveness of an investigational anticancer medication currently known as BGB-11417 in the treatment of Waldenström’s Macroglobulinemia (WM). The study will also assess if BGB11417 is safe and well tolerated by participants and how BGB-11417 may interact and/or stay in participant’s blood after they take it. The study will evaluate how BGB-11417 impact quality of life by answers collected by participant reported outcomes questionnaires.The study is composed of a screening period (up to 28 days), a treatment period, and a follow-up period. After the screening period, eligible patients will receive BGB-11417 at 320 mg once daily after an 8-day ramp-up period. Participant will begin study treatment with at a low dose and study doctor will gradually increase the dose over 8 days (ramp-up scheme) until Cycle 1 Day 1. Each treatment cycle is 28 days in duration with Cycle 1 Day 1 starting on the day participant receive the first target dose of 320 mg. After treatment discontinuation, patients will have an End of Treatment (EOT) Visit followed by a Safety Follow-up Visit.The research study is conducted and funded by BeiGene, Ltd and approximately 85 patients will be enrolled in this global study.