Trials / Completed
CompletedNCT02910583
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 323 (actual)
- Sponsor
- Pharmacyclics LLC. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ibrutinib | ibrutinib administered orally once daily (three 140 mg capsules) |
| DRUG | venetoclax | venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg. |
| DRUG | Placebo | placebo capsules to match ibrutinib administered orally once daily |
Timeline
- Start date
- 2016-09-28
- Primary completion
- 2020-11-12
- Completion
- 2024-03-27
- First posted
- 2016-09-22
- Last updated
- 2024-12-20
- Results posted
- 2022-02-18
Locations
46 sites across 6 countries: United States, Australia, Italy, New Zealand, Poland, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02910583. Inclusion in this directory is not an endorsement.