Trials / Completed
CompletedNCT02947347
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 445 (actual)
- Sponsor
- Pharmacyclics LLC. · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study to evaluate the efficacy and safety of ibrutinib in combination with rituximab versus placebo in combination with rituximab in treatment naïve participants with follicular lymphoma (FL).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ibrutinib Oral Capsule | Ibrutinib 560mg administered orally daily |
| DRUG | Placebo | Placebo capsules to match ibrutinib administered orally daily |
| DRUG | Rituximab | Rituximab 375mg/m\^2 intravenously (IV) weekly |
Timeline
- Start date
- 2017-01-23
- Primary completion
- 2024-02-21
- Completion
- 2025-06-09
- First posted
- 2016-10-27
- Last updated
- 2026-03-17
- Results posted
- 2026-03-17
Locations
128 sites across 19 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Greece, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Russia, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02947347. Inclusion in this directory is not an endorsement.