NCT01732913

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 295 (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 to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

Conditions

• Indolent Non-Hodgkin's Lymphomas

Interventions

Type	Name	Description
DRUG	Placebo	Tablets administered orally twice daily
DRUG	Rituximab	375 mg/m\^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)
DRUG	Idelalisib	150 mg tablets administered orally twice daily

Timeline

• Start date: 2013-01-16
• Primary completion: 2016-05-18
• Completion: 2016-05-18
• First posted: 2012-11-26
• Last updated: 2018-11-16
• Results posted: 2017-05-11

Locations

103 sites across 19 countries: United States, Australia, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Poland, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study