ALPINE | BGB-3111-305

ZanubrutinibCLL/SLLPhase 3Completed

Summary

This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Detailed Description

This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in 652 participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

 

The primary efficacy endpoint is overall response rate determined by investigator assessment. Participants were randomized in a 1:1 manner to either zanubrutinib or ibrutinib. Treatment with zanubrutinib and ibrutinib was open label.

Study ArmPopulationInterventionComparisonOutcome

R/R CLL/SLL


Zanubrutinib


Ibrutinib


Primary Endpoint: ORR


Key Secondary Endpoints: PFS, OS, safety


Study design

Phase III ALPINE trial design in relapsed/refractory CLL/SLL comparing zanubrutinib and ibrutinib, including eligibility criteria, stratification factors, treatment arms, and follow-up.

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