An Observational Study on Infusion-related Adverse Events at Administration of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia

Sponsor
Hoffmann-La Roche
Study ID
NCT01072240
Status
Completed

Conditions

  • Lymphocytic Leukemia, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2009
Status verified
Oct 2016
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
92 participants (actual)

Arms

  • Arm: Cohort

Primary Outcome Measure

infusion-related adverse events [ Time Frame: data collection every 4-6 weeks for up to 6 months for each patient ]

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