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
Secondary Outcome:
  • 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

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society