CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 125 enrolled
Drug / intervention
Idelalisibdrug
Likely dose
Idelalisib 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01282424
NCT01282424Phase 2Completed

A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents

Gilead Sciences·interventional·Posted Jan 25, 2011·Updated Jul 11, 2019

In Brief

A Phase 2 clinical trial evaluating Idelalisib for Follicular Lymphoma and 3 related conditions. Completed, enrolled 125 participants across 41 sites in 6 countries.

Detailed Summary

The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, Italy, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2011
Enrollment StartMar 18, 2011
Primary CompletionMay 2, 2018
Study CompletionMay 16, 2018
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 15.4 years ago

Interventions

Idelalisibdrug

Idelalisib 150 mg tablet administered orally twice daily