ROSEWOOD | BGB-3111-212

ZanubrutinibFLPhase 2Completed

Summary

This clinical study examined the safety and efficacy of the combination of zanubrutinib and obinutuzumab versus obinutuzumab alone in adults with follicular lymphoma whose disease returned after or did not respond to prior therapy.

Detailed Description

This study randomly assigned participants in a 2:1 ratio to receive either zanubrutinib plus obinutuzumab or obinutuzumab alone. The assignment considered how many prior treatments participants had received, whether their cancer had stopped responding to rituximab, and whether they were enrolled in Mainland China or other regions. Each treatment cycle lasted 28 days, with zanubrutinib taken by mouth twice daily and obinutuzumab given intravenously on a set schedule, followed by optional maintenance for up to 24 months. Participants who had obinutuzumab alone could have switched to the combination treatment if their disease worsened or did not respond after 12 months, if confirmed by an independent review.

Study ArmPopulationInterventionComparisonOutcome

R/R FL


Zanubrutinib + Obinutuzumab


Obinutuzumab


Primary Endpoint: ORR (ICR)


Secondary Endpoints: ORR (INV), DoR (ICR), PFS (ICR), OS, CR rate, CMR rate


Study design

Phase II ROSEWOOD trial design in relapsed/refractory follicular lymphoma comparing zanubrutinib plus obinutuzumab with obinutuzumab alone, including eligibility criteria, stratification factors, and follow-up.

You are now leaving the website

This link is provided for information purposes only. You’ll be leaving beonemedaffairs.com and accessing a third-party website over which [BeOne Medicines | GmbH] has no control or influence.

This link will take you to a third-party website outside of beonemedaffairs.com.

[BeOne Medicines | GmbH] has no control over this website and makes no representations regarding its content or availability in your location. [BeOne Medicines | GmbH] declines any responsibility for third-party information, data usage policies, or personal data processing.

By proceeding, you acknowledge that you are part of the intended audience of the third-party website and confirm your compliance with applicable laws.

Do you want to leave beonemedaffairs.com

You are now leaving the the website beonemedaffairs.com and entering another BeOne website with different terms of use. Information included on this website may not be specific to your country. Click Continue to proceed