Trials / Terminated
TerminatedNCT01980888
Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 311 (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 progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care. 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 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 | Bendamustine | Administered intravenously at a starting dose of 90 mg/m\^2 for up to 6 cycles. Dosing will be based on mg/m\^2 of body surface area. |
| DRUG | Rituximab | Single-use vials administered intravenously weekly starting at 375 mg/m\^2 on Day 1 (Week 0) and 500 mg/m\^2 thereafter for a total of 6 infusions |
| DRUG | Placebo | Placebo to match idelalisib administered orally twice daily |
Timeline
- Start date
- 2014-02-05
- Primary completion
- 2016-05-30
- Completion
- 2016-06-16
- First posted
- 2013-11-11
- Last updated
- 2018-11-19
- Results posted
- 2017-10-11
Locations
91 sites across 13 countries: United States, Australia, Belgium, Canada, Croatia, Czechia, France, Hungary, Italy, Poland, Romania, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01980888. Inclusion in this directory is not an endorsement.