Combination of PCI-32765 With Obinutuzumab in Untreated Follicular Lymphoma
Status:
Active, not recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
Primary Objectives The primary objective of this study is to evaluate the efficacy of the
chemotherapy-free combination of ibrutinib and obinutuzumab (GA 101) in patients with
previously untreated follicular lymphoma (FL) and a high tumor burden. Primary endpoint to be
observed for this is the rate of progression free survival one year after start of therapy.
Hypothesis The hypothesis of the study is that ibrutinib in combination with obinutuzumab
will achieve response rates (CR and PR), rates of MRD negativity and PFS which are comparable
to currently used standard rituximab-chemotherapy combinations such as R-CHOP or
R-bendamustine in subjects with previously untreated FL and a high tumor burden.