Trials / Completed
CompletedNCT03112174
Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)
Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 366 (actual)
- Sponsor
- Pharmacyclics LLC. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ibrutinib | Administered orally once daily |
| DRUG | Venetoclax | Administered orally once daily |
| DRUG | Placebo Oral tablet to match Venetoclax | Administered orally once daily |
Timeline
- Start date
- 2017-06-19
- Primary completion
- 2024-06-26
- Completion
- 2024-06-27
- First posted
- 2017-04-13
- Last updated
- 2025-07-22
- Results posted
- 2025-07-22
Locations
120 sites across 17 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03112174. Inclusion in this directory is not an endorsement.