Trials / Completed
CompletedNCT03374137
Observational Study to Monitor Safety and Effectiveness of Obinutuzumab in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia
Post-Marketing Surveillance of Gazyva in Treatment of Patients With Gazyva in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 55 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to collect clinical data, mainly focused on safety, in the local target population as per the requirement of Korea Ministry of Food and Drug Safety for market authorization. The study population comprises patients with approved local indications chronic lymphocytic leukemia (CLL) and/or follicular lymphoma (FL) in routine clinical practice after launch.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | obinutuzumab | Obinutuzumab 1000 mg solution used for infusion according to routine clinical practice. |
Timeline
- Start date
- 2018-03-09
- Primary completion
- 2022-11-10
- Completion
- 2022-11-10
- First posted
- 2017-12-15
- Last updated
- 2023-01-12
Locations
17 sites across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03374137. Inclusion in this directory is not an endorsement.