NCT01980875

Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia

A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (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 effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (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 those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Idelalisib	150 mg tablet administered orally twice daily
DRUG	Chlorambucil	2 mg tablets administered at a dose of 0.5 mg/kg orally every other week for a total of 12 doses
DRUG	Obinutuzumab	1000 mg/40 mL single-use vials administered intravenously for a total of 8 doses over 21 weeks

Timeline

• Start date: 2015-04-21
• Primary completion: 2016-05-13
• Completion: 2016-05-13
• First posted: 2013-11-11
• Last updated: 2018-11-19
• Results posted: 2017-06-28

Locations

18 sites across 8 countries: United States, Australia, Belgium, Canada, France, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study