Trials / Completed
CompletedNCT01072240
An Observational Study on Infusion-related Adverse Events at Administration of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia
An Observational Registration Study of Infusion-related Adverse Events at Administration of Mabthera (Rituximab) in the Treatment of Chronic Lymphocytic Leukemia.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 92 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This observational study will monitor and register infusion-related adverse events and their handling in patients with chronic lymphocytic leukemia on treatment with MabThera (rituximab). Data will be collected from patients receiving intravenous MabThera at a dose of 375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6 months. Target sample size is 100 patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rituximab [Mabthera/Rituxan] | As prescribed by physician |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2011-06-01
- Completion
- 2011-06-01
- First posted
- 2010-02-22
- Last updated
- 2016-11-01
Locations
18 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT01072240. Inclusion in this directory is not an endorsement.