Trials / Terminated
TerminatedNCT01659021
Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 261 (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 effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Idelalisib | 150 mg tablets administered orally twice daily |
| DRUG | Ofatumumab | Administered intravenously |
Timeline
- Start date
- 2012-12-04
- Primary completion
- 2018-08-15
- Completion
- 2018-08-15
- First posted
- 2012-08-07
- Last updated
- 2019-08-14
- Results posted
- 2017-03-31
Locations
80 sites across 11 countries: United States, Australia, Belgium, Canada, Denmark, France, Ireland, Poland, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01659021. Inclusion in this directory is not an endorsement.