NCT01569295

Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Idelalisib	Idelalisib 150 mg administered orally twice daily
DRUG	Rituximab	Rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a maximum of 6 infusions
DRUG	Bendamustine	Bendamustine 70 mg/mg\^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
DRUG	Placebo to match idelalisib	Placebo to match idelalisib administered orally twice daily

Timeline

• Start date: 2012-06-15
• Primary completion: 2019-06-10
• Completion: 2019-06-10
• First posted: 2012-04-03
• Last updated: 2020-03-10
• Results posted: 2018-02-27

Locations

106 sites across 18 countries: United States, Australia, Belgium, Canada, Croatia, Czechia, France, Greece, Hungary, Ireland, Italy, Poland, Portugal, Romania, Russia, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study