Trials / Completed
CompletedNCT03059251
Observational Study: Safety and Effectiveness of Obinutuzumab in Chronic Lymphocytic Leukemia in Argentina
An Observational Study of the Safety and Effectiveness of Obinutuzumab in Patients With Chronic Lymphocytic Leukemia Treated in Argentina
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This observational study aims to study the effectiveness and safety of Obinutuzumab in common clinical practice settings in Argentina. The study population comprises all patients with chronic lymphocytic leukemia (CLL) that have received the indication for treatment with Obinutuzumab as per routine clinical practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Obinutuzumab | Obinutuzumab will be administered as intravenous infusion for 6 cycles (28 days per cycle): 100 milligrams (mg) on day 1 Cycle 1, 900 mg on day 2 Cycle 1, 1000 mg on days 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6. |
Timeline
- Start date
- 2017-08-31
- Primary completion
- 2019-03-30
- Completion
- 2019-03-30
- First posted
- 2017-02-23
- Last updated
- 2020-04-17
Locations
3 sites across 1 country: Argentina
Source: ClinicalTrials.gov record NCT03059251. Inclusion in this directory is not an endorsement.