An Observational Registration Study of Infusion-related Adverse Events at Administration of Mabthera (Rituximab) in the Treatment of Chronic Lymphocytic Leukemia.
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Lymphocytic Leukemia, Chronic
Both
Lymphocytic Leukemia, Chronic
Trial Information
An Observational Registration Study of Infusion-related Adverse Events at Administration of Mabthera (Rituximab) in the Treatment of Chronic Lymphocytic Leukemia.
Inclusion Criteria:
- adult patients, >/= 18 years of age
- chronic lymphocytic leukemia treated with rituximab (MabThera)
- rituximab (MabThera) dosage 375 mg/m2 in cycle 1, 500 mg/m2 in subsequent cycles
- informed consent to data collection
Exclusion Criteria:
- participation in an interventional clinical study
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
infusion-related adverse events
Outcome Time Frame:
data collection every 4-6 weeks for up to 6 months for each patient
Safety Issue:
Yes
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Sweden: Regional Ethical Review Board
Study ID:
ML22754
NCT ID:
NCT01072240
Start Date:
September 2009
Completion Date:
December 2012
Related Keywords:
- Lymphocytic Leukemia, Chronic
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Chronic Disease
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