NCT02044822

Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. 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

• B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion

Interventions

Type	Name	Description
DRUG	Idelalisib	150 mg tablets administered orally twice daily
DRUG	Rituximab	375 mg/m\^2 administered intravenously once weekly x 8 weeks

Timeline

• Start date: 2014-08-06
• Primary completion: 2016-04-27
• Completion: 2016-05-17
• First posted: 2014-01-24
• Last updated: 2018-11-19
• Results posted: 2017-05-11

Locations

56 sites across 14 countries: United States, Australia, Austria, Belgium, Czechia, Denmark, France, Hungary, Italy, Poland, Portugal, Romania, Spain, United Kingdom

Regulatory

• FDA-regulated drug study