Trials / Terminated
TerminatedNCT01732926
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and 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 Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 475 (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 addition of idelalisib to bendamustine/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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Idelalisib | 150 mg tablet administered orally twice daily |
| DRUG | Rituximab | 375 mg/m\^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions) |
| DRUG | Bendamustine | 90 mg/m\^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated) |
| DRUG | Placebo | Tablet administered orally twice daily |
Timeline
- Start date
- 2013-01-02
- Primary completion
- 2016-05-17
- Completion
- 2016-05-17
- First posted
- 2012-11-26
- Last updated
- 2018-11-16
- Results posted
- 2017-05-11
Locations
144 sites across 15 countries: United States, Australia, Canada, Czechia, France, Germany, Israel, Italy, Poland, Russia, South Korea, Spain, Sweden, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01732926. Inclusion in this directory is not an endorsement.