A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (>/= 70 Years of Age) With Chronic Lymphocytic Leukemia (CLL)


The purpose of this study is to compare the progression-free survival (PFS) between control treatment and experimental treatment strategies: ibrutinib/obinutuzumab (IO) with ibrutinib maintenance (IM) versus ibrutinib/venetoclax/obinutuzumab (IVO) regardless of IM or observation.

Study Arms

  • ARM I: Patients receive ibrutinib orally
  • ARM II: Patients receive ibrutinib PO QD on days 1-28  


  • Patients must have been diagnosed with chronic lymphocytic leukemia (CLL) and have > 5000 B-cells per uL of peripheral blood at any point during the course of their disease
  • Patients must be intermediate or high-risk Rai stage CLL.
  • Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)
  • 70 Years and older (Older Adult)