Trials / Completed
CompletedNCT02264574
A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
A Randomized, Multi-center, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 229 (actual)
- Sponsor
- Pharmacyclics LLC. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ibrutinib | Ibrutinib will be supplied as 140 mg hard gelatin capsules for oral (PO) administration. |
| DRUG | Obinutuzumab | Obinutuzumab will be supplied as 1000 mg/40 mL solution in a single-use vial for intravenous (IV) administration |
| DRUG | Chlorambucil | Chlorambucil will be supplied as 2 mg film-coated tablets for oral (PO) administration |
Timeline
- Start date
- 2014-10-06
- Primary completion
- 2018-03-26
- Completion
- 2019-09-03
- First posted
- 2014-10-15
- Last updated
- 2020-09-21
- Results posted
- 2019-04-16
Locations
71 sites across 16 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Israel, Italy, New Zealand, Poland, Russia, Spain, Sweden, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02264574. Inclusion in this directory is not an endorsement.