Trials / Completed
CompletedNCT02165397
Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia
iNNOVATE Study: A Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenström's Macroglobulinemia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 181 (actual)
- Sponsor
- Pharmacyclics LLC. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ibrutinib | Participants will receive 420 mg of Ibrutinib orally. |
| DRUG | Placebo | Participants will receive placebo capsules orally. |
| DRUG | Rituximab | Participants will receive rituximab 375 mg/m\^2 IV. |
Timeline
- Start date
- 2014-07-07
- Primary completion
- 2019-11-07
- Completion
- 2019-11-07
- First posted
- 2014-06-17
- Last updated
- 2021-03-03
- Results posted
- 2020-11-16
Locations
48 sites across 9 countries: United States, Australia, Canada, France, Germany, Greece, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02165397. Inclusion in this directory is not an endorsement.