CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Idelalisibdrug
Likely dose
Not stated in 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/NCT01306643
NCT01306643Phase 2Completed
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Single-agent Idelalisib for Previously Treated Low-grade Lymphoma: A Phase 1/2 Study of Safety, Efficacy, and Flow-cytometric Assessment of Tumor-cell Signaling Events

Gilead Sciences·interventional·Posted Mar 2, 2011·Updated Nov 19, 2018

In Brief

A Phase 2 clinical trial evaluating Idelalisib for Indolent Non-Hodgkin's Lymphoma and 3 related conditions. Completed, enrolled 18 participants across 2 sites.

Detailed Summary

The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma (iNHL). Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIndolent Non-Hodgkin's Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2011
Enrollment StartFeb 1, 2011
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 15.3 years ago

Interventions

Idelalisibdrug

Tablet(s) administered orally twice daily