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)
Objective
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
Eligibility
- 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)
