Trials / Completed
CompletedNCT02320487
A Study of Obinutuzumab + Bendamustine (BG) in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
A Phase II, Open-Label Study of Obinutuzumab Plus Bendamustine (BG) in Patients With Previously Untreated Chronic Lymphocytic Leukemia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2, open-label, multicenter study to evaluate the safety and efficacy of BG induction therapy in participants with previously untreated CLL. The anticipated time on study treatment is 24 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bendamustine | Bendamustine was administered as an intravenous infusion at a dose of 90 milligrams per square meter (mg/m\^2) on Days 2 and 3 Cycle 1; and on Days 1 and 2 Cycles 2-6. |
| DRUG | Obinutuzumab | Obinutuzumab was administered as an intravenous infusion at a dose of 100 milligrams (mg) on Day 1 Cycle 1; at a dose of 900 mg on Day 2 Cycle 1; at a dose of 1000 mg on Days 8 and 15 Cycle 1, and Day 1 Cycles 2-6. |
Timeline
- Start date
- 2015-03-31
- Primary completion
- 2016-11-07
- Completion
- 2019-02-06
- First posted
- 2014-12-19
- Last updated
- 2020-02-11
- Results posted
- 2017-12-21
Locations
26 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02320487. Inclusion in this directory is not an endorsement.