NCT02968563

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

A Prospective, Open-Label, Multicenter, Phase 2 Trial to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib (GS-4059) and Idelalisib With and Without Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Tirabrutinib	Tablets administered orally
DRUG	Idelalisib	Tablets administered orally
DRUG	Obinutuzumab	Administered intravenously

Timeline

• Start date: 2016-12-13
• Primary completion: 2019-06-17
• Completion: 2021-01-14
• First posted: 2016-11-18
• Last updated: 2022-01-21
• Results posted: 2020-07-01

Locations

14 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study