Overview

Safety and Efficacy of the Combination of Tirabrutinib and Idelalisib With and Without Obinutuzumab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Status:
Completed

Trial end date:
2021-01-14

Target enrollment:

Participant gender:

Summary

The primary objective of this study is to determine the preliminary efficacy of the combination of tirabrutinib and idelalisib with obinutuzumab in adults with relapsed or refractory chronic lymphocytic leukemia (CLL). The study has a 6 participant per arm safety run-in to evaluate safety prior to the enrollment of subsequent participants. The treatment period is adaptive, with a duration of active treatment up to two years and a total follow-up on study for up to 30 days post end of treatment, or up to Week 25 should a participant discontinue treatment prior to Week 25 for reasons other than disease progression.

Phase:

Phase 2

Details

Lead Sponsor:

Gilead Sciences

Collaborators:

German CLL Study Group
Ono Pharmaceutical Co. Ltd

Treatments:

Idelalisib
Obinutuzumab