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

Roche

Status: Completed

Conditions: Lymphocytic Leukemia, Chronic

Treatments: Drug: rituximab [Mabthera/Rituxan]

Study type: Observational

Funder types: Industry

Identifiers

NCT01072240

ML22754

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

92 participants in 1 patient group

Cohort

Treatment:

Drug: rituximab [Mabthera/Rituxan]