A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

Official Title

An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

Summary:

The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.

Trial Description

Primary Outcome:

• Overall response rate (ORR) as Assessed by Independent Central Review

• Overall response rate (ORR) as Assessed by the Investigator
• Duration of response (DOR)
• Progression free survival (PFS)
• Overall Survival (OS)
• Complete Response Rate
• Complete Metabolic Response Rate
• Health-Related Quality of Life (HRQOL) as Assessed by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
• Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D version (EQ-5D-5L)
• Time to response (TTR)
• Occurrence and severity of treatment-emergent adverse events (TEAEs)

View this trial on ClinicalTrials.gov